All Posts Biopharma Clinical Trials Company Updates CTMS Drug Safety Innovation Medical Information Medical Writing MedTech Pharmacovigilance Regulatory Affairs Validation & Assurance Case Study Oncology (Breast Cancer) June 10, 2025/ Case Study Oncology (Breast Cancer) Geography: N/A Type Service: N/A Background/Client Requirement: A leading global pharma healthcare provider, driven by… Read More Case Study Neurology (Anxiety) June 10, 2025/ Case Study Neurology (Anxiety) Geography: N/A Type Service: N/A Background/Client Requirement: A prominent Nano therapeutics company, renowned for its creation… Read More Case Study Endocrinology (Diabetes mellitus) June 10, 2025/ Case Study Endocrinology (Diabetes mellitus) Geography: N/A Type Service: N/A Background/Client Requirement: Our client a leading provider of in-vitro diagnostics… Read More Case Study on Randomization in Metastatic Breast Cancer June 10, 2025/ Case Study on Randomization in Metastatic Breast Cancer Geography: N/A Type Service: N/A Background/Client Requirement: A leading global pharma healthcare… Read More Case Study on anxiety disorders June 10, 2025/ Case Study on anxiety disorders Geography: N/A Type Service: N/A Background/Client Requirement: A global pharmaceutical innovation company with a strong… Read More Case Study on Meta-Analysis of Curcuma longa June 10, 2025/ Case Study on Meta-Analysis of Curcuma longa Geography: N/A Type Service: N/A Background/Client Requirement: Our client is a prominent pharmaceutical… Read More CASE STUDY ON REGULATORY STRATEGY DEVELOPMENT AND DOSSIER SUBMISSION SUPPORT June 10, 2025/ CASE STUDY ON REGULATORY STRATEGY DEVELOPMENT AND DOSSIER SUBMISSION SUPPORT Geography: N/A Type Service: N/A Background/Client Requirement: Techsol Life Sciences was… Read More CASE STUDY ON MEDICAL DEVICE PRODUCT REGISTRATION IN INDIA June 10, 2025/ CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL) MANAGEMENT SERVICES Geography: N/A Type Service: N/A Client Background/Client Requirements: The client is… Read More CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL)MANAGEMENT SERVICES June 9, 2025/ CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL) MANAGEMENT SERVICES Geography: N/A Type Service: N/A Background/Client Requirement: Our client, a U.S…. Read More 123 How can we help you? Contact us by submitting a business inquiry online. We will get back to you very soon.  Send Message

Techsol Life Sciences is Exhibiting at DIA 2025 – Join Us in Washington, D.C.! We’re thrilled to share that Techsol Life Sciences will be exhibiting at DIA 2025, taking place from June 15–19, 2025, in the vibrant city of Washington, D.C. This premier global event brings together leaders and innovators from across the life sciences industry, and we’re excited to showcase our cutting-edge capabilities that are redefining the future of drug development and patient safety. Transforming the Future with TOTAL SolutionsAt Techsol, we believe in delivering TOTAL value through our integrated Clinical, Regulatory, MedTech, and Pharmacovigilance services. Whether you’re navigating complex regulatory environments or aiming to optimize your clinical development strategies, our comprehensive solutions are designed to accelerate timelines, enhance data quality, and ensure patient-centric outcomes. Visit Us at Booth #627Witness live product demos that illustrate the power of digital transformation in life sciences.Engage with our scientific and regulatory experts for personalized insights.Explore innovative platforms and services that can streamline your clinical development lifecycle. Let’s Connect! We invite you to book a one-on-one meeting with our team during the event. Whether you’re looking to explore strategic collaborations or just curious about what’s next in the world of life sciences innovation, we’re eager to connect, exchange ideas, and co-create a healthier future. Book a meeting with our experts at DIA 2025 Why Partner with Techsol? At Techsol, we go beyond traditional outsourcing. We are your scientific partner, dedicated to delivering intelligent, agile, and compliant solutions that support your mission of advancing human health. Our cross-functional expertise, proven technology frameworks, and client-centric approach ensure that every partnership drives real-world impact. Learn More About Our Specialized Services Clinical Read more MedTech Read more Pharmacovigilance Read more Regulatory Read more

Oracle Safety Innovation Summit Exciting News! The Techsol Life Sciences team – Satya S S Sagi Sriram Varma Kimary Pomphrett Bala Kaviti – is looking forward to meeting attendees at Oracle Life Sciences Safety Innovation Summit 2025, Reston, VA We’d love to meet you and share how Techsol Life Sciences in StartegicPartnership with Oracle Life Sciences is driving meaningful change in the Pharmacovigilance and LifeSciences industry. Learn about our end-to-end, integrated Drug Safety & Pharmacovigilance Technology Solutions and Functional Services that we delivered for more than 80+ clients. Our strategic solution delivery model includes a combination of Oracle Argus Safety, Compier PV Ops platform and SciMax medical affairs platform. Have a chat with our team and send us your requirements and business priorities. We’d be happy to present our unified business solutions that increases quality, compliance, and overall value. Schedule a Meeting With Us Submit

Establish a Regulatory Compliant Drug Safety and Signal Management Platform Through Our Technology Services In today’s fast-paced pharmaceutical industry, ensuring patient safety while maintaining regulatory compliance is more challenging than ever. With the increasing complexity of global regulations, coupled with the growing volume of safety data, companies need a powerful solution to manage drug safety effectively. Establishing a robust drug safety and signal management platform is not just a regulatory requirement—it is essential for safeguarding patients, minimizing risks, and ensuring timely responses to safety signals. At Techsol, we are committed to helping you establish a regulatory-compliant drug safety and signal management platform that drives innovation and enhances patient safety. Our comprehensive technology services are designed to simplify the complex processes of drug safety monitoring while ensuring adherence to global regulatory requirements, such as those set by the FDA, EMA, and ICH. Our Solutions As an Oracle Partner, we specialize in delivering comprehensive Oracle Argus Safety and Empirica Signal Management services that empower pharmaceutical, biotechnology, and healthcare organizations to enhance their drug safety operations. With 14+ years of experience in the industry, our expert team ensures that your safety systems are fully optimized, compliant with global regulations, and tailored to your specific needs. Safety Technology Services Oracle Argus Safety Services Read more Empirica Signal Management Read more E-Submission Gateways Read more Argus Safety Service Desk Read more Safety Data Analytics Read more Why Clients Choose Us > Expertise and Experience: Over a decade of specialized knowledge in Oracle Argus Safety and Empirica Signal Management. > Tailored Solutions: Custom-built systems to meet your unique pharmacovigilance needs. > Regulatory Compliance: Ensuring full alignment with global pharmacovigilance standards and regulations. > End-to-End Support: Comprehensive services from system implementation to ongoing support. > Efficient Project Delivery: On-time, within-budget execution with minimal disruption to your operations. > Scalability: Flexible solutions that grow with your business and adapt to your evolving needs. Request More Information Submit

Ensuring Accurate and Regulatory Compliant Safety Data Migration to Oracle Argus Safety The migration of safety data between systems is a complex change management process and requires a strategic approach and specialized expertise to preserve data quality and integrity. With a stringent pharmacovigilance regulatory landscape, pharmaceutical companies ensure that they adhere to the principles of Good Pharmacovigilance Practice (GVP) during the entire data migration process to account for safety data integrity between the source and target systems. According to GVP Module I, computer systems involved in essential pharmacovigilance activities must undergo rigorous checks, qualification, and validation. Therefore, companies must adopt a risk-based data migration strategy based on the source safety data volume, data format, ongoing safety operations, compliance objectives, etc. to ensure a smooth and successful transition.  Our Capabilities in Safety Data Migration With 14+ years experience in Drug Safety and PV technnology consulting, we have completed 35+ safety data migration projects Dedicated team of 75+ seasoned Argus Safety Technical and Functional Consultants Our ready-to-use Argus Safety Data Migration and Validation accelerators saves 50 to 70% time and effort Experienced with on-prem, cloud to cloud and other forms of legacy data migrations to Oracle Argus Safety Recognized by Oracle Health Sciences as a preferred Tech Services Provider Clients trust us an extended Safety Technology Partner for end-to-end services Our Safety Database Migration & Related Validation Services At Techsol, we understand the critical nature of safety data. Our expert team uses proven data migration methods with advanced tools to ensure your data is transferred with the highest level of accuracy. We meticulously validate each data point to avoid discrepancies and preserve data integrity throughout the migration process. Our data migration qualification is performed using the GAMP5 Risk-based methodology. We provide consulting guidance to your team at every step right from defining the data migration strategy to post-launch and hypercare. Safety Data Migration Strategy & Planning We help clients to establish a risk-based safety data migration strategy and prepare the migration plan based on: >  Source data format and case volume in legacy safety systems  >  Data migration scope, business requirements, timelines & deliverables  >  Quality and regulatory compliance objectives  >  Readiness of the target Oracle Argus Safety Cloud platform >  Identified measures for data quality assessments   Safety Data Migration Execution >  Source Data Collection: Our team uses advanced ETL tools to perform safety data extraction from different source systems and raw files (PDF, XML, JSON, etc.). The collected data is then profiled with data quality checks to ensure that all data points are available for migration.  >  Data Preparation & Transformation : All E2B field mappings, data cleansing, data transformations are performed for accurate migration into Oracle Argus Safety. >  Post-Migration Review and Support: After migration, we conduct a thorough review to ensure data accuracy and compliance. We provide ongoing support to address any issues and optimize system performance. Safety Data Migration Testing & Validation We use the GAMP-5 Risk-based validation approach to perform Data Migration Qualification.  Key Deliverables Safety Data Management –  Requirements Gathering Completion Authoring Systems Requriements Specification  Safety Data Migration Plan Setup of Case Management Management workflows Validaton Master Plan Development  Risk Management Report IQ / OQ Test Scripts Preparation & Execution  Data Migration Qualification (DMQ) Incidents & Deviation Management  Requirements Traceability matrix 21 CFR Part 11 Compliance Assessment Report  EU Annex 11 Compliance Assessment Report  Validation Closure Report End user and administration training Project Management Talk to Our Experts Common FAQs What are the common pitfalls in safety data migration? The common pitfalls and challenges faced during safety data migration include: Inadequate planning and an insufficient data migration plan Limited knowledge of the safety database and its functionality Misinterpreted business rules within the safety database Technical issues related to types and limits of input characterization Inconsistent available data Follow-up or duplicates management Data cleaning process Case related documentation (source data, correspondence, etc.) Poorly defined scope and inadequate testing, leading to a typical success rate of only 16-60% for the data migration portion of projects Mapping errors, different dictionary maintenance practices, and MedDRA/WHO coding inconsistencies To mitigate these challenges, it is crucial to develop a thorough Data Migration Plan that evaluates different approaches, products, or the number of cases that will be migrated. The plan should include a clear strategy, guidance to mitigate interruptions, and steps to achieve compliance. Additionally, pre-migration testing, configuration of migration software, and parallel process reengineering can help address these pitfalls Can Techsol assist with regulatory reporting after migration? Yes, Techsol can set up and automate the generation of various regulatory reports, including ICH E2B R3 electronic submissions, periodic safety update reports, and other compliance-related documentation, ensuring ongoing adherence to regulatory requirements. What kind of training does Techsol provide for users post-migration? Techsol provides various training sessions tailored to different user roles, including case management, application administration, and superuser training. This ensures that all users are well-equipped to utilize the Argus Safety system effectively. Request a Free Consultation Submit

Urology Conducting clinical trials in urology presents several challenges due to the unique nature of urological conditions and the complexities involved in studying them. One significant hurdle is patient recruitment, as individuals with urological disorders may feel uncomfortable discussing their symptoms or may be hesitant to participate in clinical research. Additionally, the variability in disease progression and response to treatment among patients adds complexity to trial design and outcome assessment. Another challenge is ensuring adequate blinding and control in trials involving surgical interventions or medical devices, as these may pose challenges in maintaining standardization and minimizing bias.  Moreover, ethical considerations regarding patient privacy and informed consent, particularly in trials involving sensitive topics such as sexual health or fertility, require careful navigation. Additionally, regulatory requirements for urological clinical trials, including the need for robust endpoints and long-term follow-up, can pose logistical and financial challenges. Despite these obstacles, innovative trial designs, interdisciplinary collaborations, and patient-centered approaches can help overcome challenges and advance the field of urology by bringing new and effective treatments to patients. How We Can Help Our clinical research services have been pivotal in propelling progress in urology treatments. By focusing on enhancing patient outcomes and advancing urological health, we’ve made significant contributions to the development of innovative therapies and interventions. Covering a wide spectrum of urological conditions, including prostate disorders, urinary tract infections, kidney stones, and urinary incontinence, our expertise is dedicated to addressing the unique challenges in this field. Below are some of our key specialties: Urinary tract infections (UTIs): Proficient in conducting clinical trials to evaluate the efficacy of antibiotics, vaccines, and preventive measures for UTIs, addressing both acute and recurrent infections. Kidney stones: Experienced in testing pharmacological interventions, dietary modifications, and minimally invasive procedures for the prevention and management of kidney stones, focusing on reducing recurrence and alleviating symptoms. Benign prostatic hyperplasia (BPH): Specialized in assessing the effectiveness of alpha-blockers, 5-alpha reductase inhibitors, and minimally invasive treatments for BPH symptom relief and prostate volume reduction. Prostatitis: Skilled in conducting trials to evaluate antimicrobial therapies, alpha-blockers, and anti-inflammatory agents for the treatment of acute and chronic prostatitis, addressing pain management and symptom improvement. Erectile dysfunction (ED): Proficient in testing phosphodiesterase inhibitors, intracavernosal injections, and vacuum erection devices for the management of ED, focusing on enhancing sexual function and quality of life. Urinary incontinence: Experienced in evaluating pharmacological agents, pelvic floor exercises, and surgical interventions for the treatment of urinary incontinence, addressing both stress and urge incontinence. Bladder cancer: Specialized in conducting trials to assess the efficacy of chemotherapy, immunotherapy, and targeted therapies for bladder cancer management, focusing on tumor control and disease progression. Testicular cancer: Skilled in evaluating multimodal treatments, including surgery, chemotherapy, and radiation therapy, for the management of testicular cancer, with a focus on achieving optimal oncologic outcomes and preserving fertility. Overactive bladder (OAB): Proficient in testing anticholinergic medications, beta-3 adrenergic agonists, and neuromodulation techniques for OAB symptom relief and bladder function improvement. Interstitial cystitis/bladder pain syndrome (IC/BPS): Experienced in conducting trials to assess oral medications, bladder instillations, and neuromodulation therapies for the management of IC/BPS symptoms, focusing on pain reduction and improving bladder function. Our Services We offer a comprehensive suite of services designed to support every aspect of urology research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. Harnessing our extensive expertise in urological conditions, we meticulously design tailored trials aimed at addressing the diverse needs of patients. Our approach is characterized by a deep understanding of urological diseases, allowing us to contribute significantly to the development of innovative therapies and interventions. Through collaborative efforts and a patient-centered ethos, we ensure comprehensive care throughout the trial process, fostering trust and engagement while facilitating the collection of robust data. This commitment enables us to accelerate the translation of research findings into effective treatments, ultimately improving outcomes and quality of life for individuals grappling with urological disorders. Our Experience S. No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Solifinacine succinate   ✔         2 Alfuzosin Hydrochloride     ✔   ✔   3 ILUP ✔ ✔ ✔ ✔ ✔ ✔ 4 Lanthanum     ✔ ✔ ✔   5 Sildenafil     ✔ ✔ ✔   Request More Information Submit

Neurology & Psychiatry Conducting clinical trials in neurology and psychiatry presents a myriad of challenges stemming from the intricate nature of these conditions. With neurological and psychiatric disorders encompassing a diverse spectrum of diseases, each characterized by unique etiologies and manifestations, designing effective trials requires careful consideration of numerous factors. One significant obstacle lies in patient recruitment and retention, as individuals grappling with these conditions often face stigma, logistical barriers, and fluctuating symptoms that may impede their participation and adherence to trial protocols. Moreover, the subjective nature of many psychiatric symptoms adds complexity, necessitating the incorporation of objective biomarkers and rigorous methodologies to ensure the reliability and validity of trial outcomes. Ethical considerations also loom large, particularly regarding informed consent, privacy, and the potential risks associated with experimental interventions. However, amidst these challenges, best practices in neurology and psychiatry clinical trials emphasize interdisciplinary collaboration, innovative trial designs, and patient-centered approaches. By leveraging advances in technology, such as neuroimaging and digital health tools, researchers can enhance trial efficiency and precision while facilitating remote monitoring and data collection. Furthermore, promoting diversity and inclusivity in trial populations and fostering transparent communication with stakeholders are vital for ensuring the generalizability and impact of trial findings.  How We Can Help Our clinical research services have been instrumental in driving forward therapies for a diverse spectrum of neurological and psychiatric disorders. Through our dedication and expertise, we have contributed significantly to the development of innovative treatments and interventions aimed at alleviating symptoms and improving the quality of life for individuals affected by these conditions. Below are some of our key areas of expertise: ADHD: Specialized in evaluating the efficacy and safety of novel medications and behavioral interventions for attention-deficit/hyperactivity disorder. Alzheimer’s: Expertise in conducting trials focusing on disease-modifying therapies, cognitive enhancers, and symptom management approaches for Alzheimer’s disease. Anxiety disorders: Proficient in testing pharmacological agents, psychotherapeutic interventions, and neuromodulation techniques for various anxiety disorders, including generalized anxiety disorder and panic disorder. Depression: Experienced in assessing the effectiveness of antidepressant medications, psychotherapy modalities, and emerging treatments such as ketamine infusion therapy for depression. Schizophrenia: Skilled in conducting trials to evaluate antipsychotic medications, psychosocial interventions, and cognitive remediation strategies for schizophrenia spectrum disorders. Bipolar disorder: Proficiency in testing mood stabilizers, antipsychotics, and adjunctive therapies for bipolar disorder management, including both acute episodes and maintenance treatment. Diabetic neuropathic pain: Specialized in evaluating pharmacological agents and non-pharmacological interventions for managing neuropathic pain in individuals with diabetes. Fibromyalgia: Expertise in conducting trials to assess the efficacy of pharmacological treatments, cognitive-behavioral therapy, and exercise interventions for fibromyalgia symptom management. Epilepsy: Proficient in testing antiepileptic medications, surgical interventions, and neuromodulation techniques for seizure control and epilepsy management. Migraine: Skilled in evaluating acute and preventive migraine treatments, including medications, neuromodulation devices, and behavioral therapies. Seizures: Experienced in conducting trials to assess the efficacy of antiepileptic drugs and interventions for seizure management across various seizure types and epilepsy syndromes. Our Services We offer a comprehensive suite of services designed to support every aspect of neurology and psychiatry research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. Drawing upon our extensive expertise in neurological and psychiatric disorders, we meticulously design tailored trials to address the diverse needs of patients. By integrating innovative methodologies and leveraging cutting-edge technologies, we not only track patient progress with precision but also contribute to the development of novel treatment modalities, encompassing pharmacological agents, psychotherapeutic interventions, and neuromodulation techniques. Our patient-centric ethos ensures that individuals receive comprehensive care throughout the trial process, fostering trust and engagement while facilitating the collection of robust data. This commitment to excellence enables us to accelerate the translation of research findings into effective therapies, ultimately improving outcomes and quality of life for individuals grappling with neurological and psychiatric disorders. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Topiramate ✔   ✔   ✔   2 Donepezil   ✔         3 Divalproex Sodium   ✔         4 Amantadine Capsules ✔   ✔ ✔ ✔   5 Atomoxetine   ✔         6 Memantine   ✔   ✔ ✔   7 Mirtazepine   ✔         8 Cannabidol ✔ ✔ ✔ ✔ ✔ ✔ 9 Vilazodone Hydrochloride     ✔       10 Lurasidone Hydrochloride   ✔ ✔       11 Deuloxitine   ✔         12 Citalopram     ✔   ✔   13 Escitalopram     ✔ ✔ ✔   14 Sertraline ✔   ✔       15 Bupropion     ✔   ✔   Request More Information Submit

Allergy and Immunology Conducting allergy and immunology clinical trials presents a myriad of challenges stemming from the intricate nature of immune responses and the diversity of allergens and immune-mediated diseases. One primary obstacle lies in patient recruitment and retention, as individuals with specific allergies or immunological conditions may be geographically dispersed or hesitant to participate due to the complexities of their conditions. Additionally, the variability in allergic reactions and immune responses among participants necessitates meticulous trial design and outcome measures to ensure robust data collection.  Furthermore, navigating ethical considerations, such as potential risks associated with allergen exposure during trials, requires careful deliberation and adherence to stringent safety protocols. Moreover, the evolving landscape of allergens and immunomodulatory therapies underscores the importance of staying abreast of scientific advancements and regulatory guidelines to effectively address emerging challenges and optimize trial outcomes. Overall, overcoming these hurdles demands a multidisciplinary approach, robust collaboration between stakeholders, and a steadfast dedication to advancing our understanding and treatment of allergic and immunological disorders. How We Can Help Our clinical research services have been instrumental in driving forward therapies for a broad spectrum of allergy and immunology disorders. Through our dedication and expertise, we’ve contributed significantly to the development of innovative treatments and interventions aimed at mitigating allergic reactions and modulating immune responses. Our specialized focus encompasses a diverse array of conditions which are listed below: Allergic rhinitis: Our expertise in conducting clinical trials for allergic rhinitis stems from our comprehensive understanding of allergen exposure dynamics and our ability to assess the efficacy of novel treatments in alleviating symptoms. Asthma: With a focus on personalized treatment approaches, our clinical trials expertise in asthma revolves around optimizing bronchodilator therapies and exploring immunomodulatory interventions to manage airway inflammation effectively. Food allergies: We excel in conducting clinical trials for food allergies by meticulously evaluating allergen-specific immunotherapies and elucidating underlying mechanisms to develop targeted interventions for improved tolerance. Atopic dermatitis: Leveraging our knowledge of skin barrier function and immune dysregulation, our clinical trials expertise in atopic dermatitis centers on testing novel topical agents and biologic therapies to alleviate symptoms and prevent flare-ups. Allergic conjunctivitis: Our proficiency in conducting clinical trials for allergic conjunctivitis lies in our ability to assess the efficacy of antihistamines, mast cell stabilizers, and immunomodulatory agents in alleviating ocular symptoms and improving quality of life. Drug allergies: With a focus on precision medicine, our clinical trials expertise in drug allergies involves rigorous allergen testing and individualized desensitization protocols to safely manage hypersensitivity reactions and expand therapeutic options. Allergic reactions to insect stings: We specialize in conducting clinical trials for allergic reactions to insect stings by evaluating the efficacy of venom immunotherapy and exploring novel approaches to prevent severe systemic reactions. Immunodeficiencies: Our expertise in conducting clinical trials for immunodeficiencies revolves around identifying genetic predispositions, evaluating immune system function, and testing innovative immunomodulatory therapies to enhance immune response and prevent infections. Autoimmune diseases: With a focus on immune modulation and tolerance induction, our clinical trials expertise in autoimmune diseases encompasses testing biologic agents, small molecule inhibitors, and cell-based therapies to mitigate disease progression and restore immune homeostasis. Our Services We offer a comprehensive suite of services designed to support every aspect of allergy and immunology related  research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage.  By leveraging our in-depth understanding of immunological mechanisms and allergen-specific pathways, we’ve played a pivotal role in improving patient outcomes and advancing the frontier of allergy and immunology care. We distinguish ourselves in clinical research within allergy and immunological disorders by adopting a holistic approach that extends beyond medication testing. Drawing upon our profound understanding of immune system dynamics and allergen-specific pathways, we design meticulously tailored trials to address the nuanced needs of patients. By integrating innovative methodologies and leveraging cutting-edge technologies, we not only track patient progress with precision but also contribute to the development of novel treatment modalities, encompassing immunotherapies, biologics, and personalized interventions. Our patient-centric ethos ensures that individuals receive comprehensive care throughout the trial process, fostering trust and engagement while facilitating the collection of robust data. This commitment to excellence enables us to accelerate the translation of research findings into effective therapies, ultimately improving outcomes and quality of life for individuals grappling with allergy and immunological disorders. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Desloratidine ✔ ✔   ✔ ✔   2 Bilastine   ✔ ✔ ✔ ✔   3 Cetrizine ✔ ✔   ✔   ✔ 4 Montelukast Sodium and Levocetirizine Dihydrochloride   ✔   ✔   ✔ Request More Information Submit

Dermatology Conducting dermatology clinical trials presents a unique set of challenges due to the diverse nature of skin conditions and the intricacies of skin biology. One significant challenge is the subjective nature of many dermatologic assessments, making standardization and reproducibility difficult. Additionally, patient recruitment can be challenging as dermatologic conditions often vary in severity and manifestation, requiring specific inclusion criteria. Furthermore, ensuring adequate blinding in trials evaluating topical treatments poses challenges, particularly when comparing to placebo or other active agents.  Variability in environmental factors such as climate and sun exposure can also impact trial outcomes. Moreover, adherence to treatment regimens and follow-up visits can be influenced by cosmetic concerns, lifestyle factors, and socioeconomic status. Despite these challenges, advancements in imaging techniques, biomarkers, and patient-reported outcomes are helping to overcome these hurdles and improve the quality and reliability of dermatology clinical trials, ultimately leading to better treatments for skin disorders. How We Can Help Our clinical research services have been instrumental in driving progress in dermatology, tackling a diverse array of skin conditions and advancing therapeutic options for patients worldwide. Through our efforts, we have contributed significantly to the development of novel dermatologic medications and treatment modalities, thereby elevating patient outcomes and promoting skin health. Following are some of our key areas of dermatological expertise: Alopecia: Our clinical expertise includes various forms of hair loss, including alopecia areata, androgenetic alopecia, and telogen effluvium, with a focus on identifying effective treatment options to promote hair regrowth and improve patient quality of life. Plaque Psoriasis: We specialize in conducting clinical trials for plaque psoriasis, evaluating novel therapeutics aimed at reducing inflammation, alleviating symptoms, and achieving long-term remission, thus enhancing the management of this chronic skin condition. Eczema: Our clinical research expertise extends to eczema, encompassing atopic dermatitis and other forms of this inflammatory skin condition. We specialize in evaluating novel treatments to alleviate itching, reduce inflammation, and improve the overall quality of life for patients with eczema, addressing both acute flare-ups and long-term management strategies. Cosmetic Concerns: Our research extends beyond medical dermatology to address cosmetic concerns such as fine lines, smoker lines, crow’s feet lines, and superficial frontal wrinkles, with a focus on developing innovative interventions to rejuvenate and enhance skin appearance. Skincare Concerns: We also have expertise in skincare concerns beyond facial aesthetics, including the management of necklines, décolleté lines, and dry skin, offering comprehensive solutions to promote skin health and address cosmetic issues across various body areas. Our Services We offer a comprehensive suite of services designed to support every aspect of dermatology research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. At the forefront of dermatology clinical trials, we transcend conventional methodologies by embodying a relentless commitment to innovation and patient-centric care. With a deep understanding of dermatological conditions, we meticulously craft trials that not only assess treatment efficacy but also unravel underlying mechanisms, paving the way for tailored interventions. Our approach is anchored in collaboration, actively engaging with patients to enrich our insights and refine treatment approaches. By seamlessly integrating scientific rigor with empathy and creativity, we catalyze the development of transformative therapies, ultimately reshaping the landscape of dermatological care and empowering individuals to embrace a brighter, healthier future. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Mintop Shampoo ✔ ✔         2 Venusia Baby Moisturizer   ✔       ✔ 3 Hyaluronic Acid- Dermal filler ✔ ✔   ✔ ✔   4 Gloderm Comfort 12L   ✔   ✔ ✔   5 Apremilast ✔   ✔ ✔     Request More Information Submit

Diabetes & Endocrinology Conducting clinical trials in the field of Diabetes & Endocrinology presents a myriad of challenges that demand meticulous planning and execution. One significant obstacle lies in patient recruitment and retention, as individuals with these conditions often have complex medical histories and may be hesitant to participate in lengthy trials. Moreover, ensuring compliance with treatment protocols and managing confounding variables such as diet, exercise, and concomitant medications poses a constant challenge. Standardizing outcome measures across diverse patient populations can also be arduous, given the heterogeneous nature of diabetes and endocrine disorders.  Additionally, regulatory requirements and ethical considerations add layers of complexity to trial design and implementation. Despite these hurdles, innovative approaches such as decentralized trials and personalized medicine hold promise for overcoming these challenges and advancing our understanding and treatment of these conditions. How We Can Help Our expertise encompasses a range of specialties within Diabetes and Endocrinology, including but not limited to innovative approaches to insulin therapy, novel treatments for hormone imbalances, and groundbreaking research into metabolic disorders. By focusing on these key areas, we aim to continue making strides in the field, ultimately improving the lives of those affected by diabetes and endocrine disorders. Type-2 diabetes: Extensive experience in conducting clinical trials for novel medications and treatment strategies aimed at managing Type-2 diabetes, focusing on improving glycemic control and reducing complications. Diabetic dyslipidemia: Specialized expertise in investigating the relationship between lipid metabolism and diabetes, with a focus on developing interventions to address dyslipidemia in diabetic patients. Wound care: Proven track record in conducting clinical trials to evaluate innovative wound care products and therapies, aimed at accelerating wound healing and reducing the risk of complications in diabetic patients. Hyperglycemia: In-depth understanding of the mechanisms underlying hyperglycemia and extensive experience in testing new interventions to effectively manage blood glucose levels in diabetic patients. Acromegaly: Specialized knowledge and experience in conducting clinical trials for therapies targeting the underlying causes of acromegaly, focusing on improving symptom management and quality of life for affected individuals. Hypothyroidism: Expertise in designing and implementing clinical trials to evaluate the safety and efficacy of treatments for hypothyroidism, with a focus on optimizing thyroid hormone replacement therapy. Blood glucose monitoring: Comprehensive understanding of blood glucose monitoring technologies and methodologies, with a focus on validating and improving the accuracy and usability of glucose monitoring devices through rigorous clinical testing. Our Services We offer a comprehensive suite of services designed to support every aspect of diabetes and endocrinology research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. Our approach to conducting diabetes and endocrinology clinical trials is characterized by a patient-centric focus, emphasizing the needs and experiences of patients while minimizing burdensome procedures and fostering clear communication to enhance engagement and retention. We promote multidisciplinary collaboration among healthcare professionals to address the complexity of these conditions comprehensively. Leveraging innovative technologies such as continuous glucose monitoring systems and wearable devices, we collect real-time data and monitor patient progress remotely, improving accuracy and convenience.  Personalized medicine is at the forefront of our trials, tailoring treatment strategies based on individual characteristics and biomarker analysis. Through community engagement and outreach programs, we raise awareness and advocate for preventive measures. Longitudinal follow-up is integral to our trials, allowing us to assess the sustained efficacy and safety of interventions over time, informing long-term management strategies. This holistic approach aims to advance the field, improve patient outcomes, and positively impact the lives of those affected by diabetes and endocrine disorders. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Evogliptin ✔           2 Saroglitzar           ✔ 3 A Study on Control of Diabetes in School and Hostel   ✔         4 Metformin   ✔         5 Accu check Safe-T-Pro Uno     ✔ ✔ ✔   6 Roche diabetes care platform     ✔   ✔   7 Accu check my sugar log book     ✔       8 Insulin ✔ ✔   ✔ ✔   9 Dapagliflozin 5mg & 10 mg   ✔         10 Accu-Chek Active, Accu-Chek Instant, Accu-Chek Instant S     ✔ ✔ ✔   11 Blood Glucose Monitoring test strips and  app ✔   ✔       12 Linagliptin 5 mg   ✔         13 Accu-Chek Softclix Kits (Lancets + Lancing Device) ✔   ✔       14 Accu-Chek SugarView Color Card ✔   ✔       15 Vildagliptin + Metformin   ✔         16 Dapagliflozin+Metformin   ✔         17 KAP Survey   ✔   ✔ ✔   18 Beat sugar view(Accu check)       ✔ ✔ ✔ 19 Jusline-R ✔   ✔ ✔ ✔ ✔ 20 Jusline-N ✔   ✔ ✔ ✔ ✔ 21 Jusline-30/70 ✔   ✔ ✔ ✔ ✔ 22 Smart  Survey   ✔   ✔ ✔   23 OAD  Survey   ✔         24 MNT & DID Survey   ✔   ✔ ✔   25 GALACTOSEMIA   ✔         26 A study on Transient thyro-adrenal failure   ✔         27 A study on Hypothyroidism (Q’SHY)       ✔ ✔ ✔ 28 Sevelamer Carbonate     ✔       29 Lanreotide     ✔       Request More Information Submit

Cardiology Cardiovascular clinical trials are scientifically complex due to the multifaceted nature of heart disease. Patient variability, the need for diverse endpoints (mortality, function, quality of life), long-term follow-up requirements, and the challenge of finding reliable biomarkers all necessitate a team with deep scientific understanding, robust trial design skills, and meticulous data analysis capabilities. We are a leading Contract Research Organization (CRO) with extensive experience in designing, managing, and executing successful clinical trials for a wide range of cardiovascular diseases. Our team of seasoned medical and clinical experts is passionate about propelling the development of life-saving therapies that improve patient outcomes. How We Can Help Our clinical research services have played a pivotal role in advancing therapies for a wide range of cardiovascular diseases. We have contributed to the development of cardiovascular medications and medical devices that have enhanced patient outcomes and improved cardiovascular health. Following are some of our key specialties: Hypertension: Expertise in developing and evaluating medications for long-term blood pressure control, including innovative therapies for resistant hypertension. Chronic Stable Angina Pectoris: Proven track record in designing and conducting trials for medications that improve exercise tolerance and quality of life in angina patients. Vasospastic Angina: Experience in researching and developing therapies specifically targeting vasospasms and reducing angina attacks. Edema due to Cardiac Failure: A focus on clinical trials for diuretics and other medications that effectively manage fluid buildup and improve patient outcomes in heart failure. Stroke and Systemic Embolism: Expertise in trials for stroke prevention medications, including blood thinners and antiplatelet drugs, as well as interventions to reduce blood clot formation. Coronary Heart Disease: A comprehensive approach to developing and testing medications for coronary artery disease prevention and management, including cholesterol-lowering drugs and therapies that improve blood flow to the heart. Acute Coronary Syndrome and Acute Myocardial Infarction: Proven experience in designing and conducting time-sensitive clinical trials for medications that improve outcomes in patients experiencing heart attacks and acute coronary events. Left Ventricular Hypertrophy: Expertise in researching and developing therapies that prevent or reverse heart muscle thickening, a major risk factor for heart failure. Ventricular Arrhythmias: A focus on clinical trials for medications and devices that effectively control irregular heartbeats and reduce the risk of sudden cardiac death. Aortic Stenosis: Experience in designing trials for medications and minimally invasive procedures to improve outcomes in patients with a narrowed aortic valve. Our Services We offer a comprehensive suite of services designed to support every aspect of cardiovascular research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. We set ourselves apart in clinical research by going beyond just testing medications. We leverage our in-depth knowledge of cardiovascular diseases to design targeted trials, meticulously track patient progress, and contribute to the development of innovative treatment approaches for a broad spectrum of heart conditions. This patient-centric approach ensures we gather robust data to bring effective therapies to market faster. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Amiodarone   ✔         2 Amlodipine   ✔         3 Furosemide ✔ ✔   ✔ ✔   4 Apixaban   ✔         5 Ezetimibe ODT 10 mg   ✔         6 Telmisartan+ Hydrochlorothiazide   ✔   ✔ ✔   7 Telmisartan+ Amlodipine   ✔         8 Telmisartan + Amlodipine +Hydrochlorothiazide   ✔   ✔ ✔ ✔ 9 Ezetimibe and Atorvastatin   ✔         10 Lisinopril     ✔       11 Diltiazem     ✔       12 Clopidogrel   ✔   ✔ ✔   13 Losartan Potasium   ✔   ✔ ✔   14 Fenofibrate     ✔     ✔ 15 Trans catheter Aortic Valve System ✔           16 Lidocaine     ✔ ✔ ✔   17 Nadolol     ✔       Request More Information Submit

Oncology Oncology clinical trials face a multitude of challenges stemming from the inherent complexity and heterogeneity of cancer, as well as the rapidly evolving landscape of oncology research and treatment modalities. One of the primary challenges lies in patient recruitment and retention, as oncology trials often require specific eligibility criteria and may involve intensive treatments or lengthy follow-up periods. Additionally, the diversity of cancer types, subtypes, and molecular alterations necessitates tailored trial designs and personalized treatment approaches, posing logistical and methodological complexities. Regulatory requirements, ethical considerations, and patient safety concerns further contribute to the intricate nature of oncology trials, requiring meticulous oversight and adherence to stringent protocols.  Furthermore, the emergence of novel targeted therapies, immunotherapies, and biomarker-driven approaches introduces complexities related to patient stratification, biomarker validation, and predictive modeling, demanding innovative trial methodologies and collaborative efforts across multidisciplinary teams. Despite these challenges, oncology clinical trials play a crucial role in advancing cancer care and improving patient outcomes by facilitating the development and validation of new treatments and diagnostic strategies. How We Can Help At Techsol Life Sciences we have developed competence in conducting oncology clinical trials, leveraging our extensive expertise, innovative methodologies, and dedicated team of oncology specialists. We have partnered with sponsors to successfully launch new products in the following areas: Treatment of Metastatic Breast Cancer: Extensive experience in conducting clinical trials evaluating novel therapies for metastatic breast cancer. Non-Small Cell Lung Cancer (NSCLC): Specialized knowledge in the management of NSCLC, including both early-stage and metastatic disease. Myelofibrosis: In-depth understanding of the pathophysiology and treatment landscape of myelofibrosis. Severe Thrombocytopenia: Expertise in conducting trials focused on the management of severe thrombocytopenia in various disease contexts. Prostate Cancer: Comprehensive understanding of prostate cancer biology, including hormone-sensitive and castration-resistant disease states. Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Specialized expertise in the diagnosis and management of GEP-NETs, encompassing a spectrum of gastrointestinal and pancreatic neuroendocrine tumors. With a profound understanding of the complexities inherent in cancer research, we meticulously design tailored trial protocols, optimize patient recruitment strategies, and implement rigorous quality assurance measures to ensure data integrity and reliability.  By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. Through strategic collaborations with diverse clinical sites, and academic institutions, we facilitate access to diverse patient populations and cutting-edge research methodologies, enabling the development and validation of novel oncology therapies and diagnostic tools. Our unwavering commitment to advancing cancer care and improving patient outcomes drives us to remain at the forefront of oncology research, continuously striving for innovation and excellence. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Pertuzumab (ZRC-3277) ✔       ✔   2 Pacritinib   ✔       ✔ 3 Leuprolide     ✔       4 Doxorubicin ✔ ✔ ✔ ✔ ✔   5 ZRC-3276 (Nivolumab) IV infusion       ✔ ✔   6 Alfuzosin Hydrochloride   ✔ ✔       7 Tamsulosin Hydrochloride ✔   ✔   ✔   Request More Information Submit

Orthopaedics & Rheumatology Bone and joint (orthopedic) and arthritis (rheumatology) clinical trials are difficult especially when it comes to recording patient outcomes.  The sheer number of conditions, from various arthritis subtypes to fractures and sports injuries, makes finding a consistent patient group tricky. This directly impacts how well the results can be applied more broadly. On top of that, measuring success is no walk in the park. Pain, stiffness, and function can vary greatly between people, making it hard to objectively measure a treatment’s effectiveness compared to other fields with clear-cut metrics. These challenges demand specialized expertise to navigate the complexities of musculoskeletal research. How We Can Help Our highly skilled team brings unparalleled experience to designing, managing, and executing successful clinical trials across the entire spectrum of musculoskeletal conditions. We have a proven track record in both surgical and non-surgical interventions, focusing on improving patient outcomes and mobility. Following are some of the key indications where we have provided our clinical & data services: Rotator Cuff Tears: Leaders in clinical trials for surgical techniques, rehabilitation methods, and implants to repair rotator cuff tears. Arthroscopic ACL Reconstruction: Extensive experience in trials for new approaches and technologies in ACL reconstruction using minimally invasive arthroscopic techniques. Arthroscopic Shoulder Ligament Tear Repair: Expertise in designing and conducting trials for arthroscopic repair of various shoulder ligament tears. Arthroscopic Bankart Repair: Proven track record in trials focused on arthroscopic Bankart repair for recurrent shoulder instability. Sprains and Acute Traumatic Tendinitis: Leaders in clinical trials for treatments and rehabilitation strategies for sprains and acute traumatic tendinitis. Knee Osteoarthritis: Broad expertise in trials for managing knee osteoarthritis, including pain management strategies and potential joint replacement solutions. Musculoskeletal Pain: Extensive experience in designing and conducting trials for various causes of musculoskeletal pain, exploring treatment options and pain management approaches. Rheumatoid Arthritis: Proven track record in trials for new medications and therapies to manage inflammation, pain, and joint damage associated with rheumatoid arthritis. Ankylosing Spondylitis: Expertise in designing clinical trials for ankylosing spondylitis, focusing on new therapies to manage inflammation, pain, and stiffness associated with this condition. Joint Pain: Leaders in trials for treatments and management strategies for various causes of joint pain. Our Services Our team leverages cutting-edge clinical trial technology and deep expertise in musculoskeletal conditions to deliver efficient and cost-effective solutions. We offer a comprehensive suite of services, guiding you through the entire clinical trial journey – from feasibility assessments and investigator selection to patient recruitment, regulatory submissions, and post-approval support. This includes expert medical writing for trial protocols, meticulous clinical data management, robust biostatistical analysis, and unwavering vigilance in ensuring patient safety and device performance reporting By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Suture Button and Interference Screw (Knee) ✔ ✔   ✔ ✔ ✔ 2 Suture Anchor-Repair (Shoulder) ✔ ✔   ✔ ✔ ✔ 3 Suture Anchor-Restoration (Shoulder) ✔ ✔   ✔ ✔ ✔ 4 Suture Anchor-Ligment Tear Repair (Shoulder) ✔ ✔   ✔ ✔ ✔ 5 Suture Button/ Intereference Screw (Knee) ✔ ✔   ✔ ✔ ✔ 6 Fixed Loop UHMWPE Suture Titanium Button and Titanium Inteference Screw (Knee) ✔ ✔   ✔ ✔ ✔ 7 Knotted UHMWPE Suture Titanium Anchor (Shoulder) ✔ ✔   ✔ ✔ ✔ 8 Knotted UHMWPE Suture Anchor (Shoulder) ✔ ✔   ✔ ✔ ✔ 9 Suture Button & Peek Button (Knee) ✔ ✔   ✔ ✔ ✔ 10 Nimesulide ✔ ✔   ✔ ✔ ✔ 11 Butaproxyvon   ✔         12 Aceproxyvon   ✔         13 Enzoflam   ✔         14 Penicillamine     ✔       15 Ibuprofen   ✔   ✔     Request More Information Submit

Gastroenterology Gastroenterology clinical trials grapple with multifaceted challenges, including the intricacies of patient recruitment and retention, especially in long-term studies necessitated by chronic gastrointestinal conditions. The diverse spectrum of gastrointestinal diseases adds another layer of complexity, demanding tailored trial designs to capture the heterogeneity of patient populations and disease manifestations. Moreover, placebo responses, particularly pronounced in functional gastrointestinal disorders, pose a significant hurdle to demonstrating treatment efficacy.  Additionally, the identification of suitable endpoints and biomarkers remains a pressing concern, as does navigating the intricate landscape of regulatory requirements, especially for conditions with systemic implications like inflammatory bowel disease. Addressing these challenges necessitates innovative approaches and collaborative efforts across stakeholders to advance the development of effective therapies in gastroenterology. How We Can Help At Techsol Life Sciences, we have unparalleled expertise in gastroenterology clinical trials, specializing in the following areas: Acute Nausea: Profound understanding of the underlying mechanisms and effective management strategies, ensuring comprehensive treatment evaluation in clinical trials. Duodenal Ulcers: Extensive experience in assessing novel therapeutic interventions for the prevention and treatment of duodenal ulcers, including rigorous endpoint selection and patient monitoring. Esophagitis: In-depth knowledge of esophageal inflammation mechanisms and innovative approaches for evaluating treatment efficacy and safety in clinical trials. Gastric Ulcer: Expertise in designing trials to address the complexities of gastric ulcer pathophysiology, with a focus on developing targeted therapies and optimizing patient outcomes. Gastroesophageal Reflux Disease (GERD): Proven track record in conducting GERD trials, incorporating state-of-the-art diagnostic tools and patient-reported outcomes to assess treatment effectiveness and symptom relief. Vomiting: Specialized protocols for evaluating novel antiemetic agents and identifying optimal treatment regimens for managing vomiting in various clinical settings. Zollinger-Ellison Syndrome: Comprehensive understanding of the pathogenesis of Zollinger-Ellison Syndrome and experience in evaluating innovative treatment modalities to control gastric acid hypersecretion and improve patient quality of life. Our Services We offer a comprehensive suite of services designed to support every aspect of gastroenterology research and clinical development. From designing and conducting clinical investigations to managing data, analyzing results, and ensuring regulatory compliance. Our services encompass site feasibilities, investigator selection, patient recruitment strategies, IRB submissions, GCP site audits, medical writing, biostatistics, SAS programming, device vigilance, safety reporting, and regulatory support. By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. With our specialized expertise, Techsol Life Sciences excels in conducting gastroenterology trials, implementing unique approaches to ensure success. One such approach involves leveraging advanced data analytics and patient recruitment strategies to identify and enroll suitable participants efficiently. Additionally, we employ patient-centric trial designs, integrating digital health technologies and remote monitoring solutions to enhance patient engagement and retention throughout the study duration. Our multidisciplinary team collaborates closely with key opinion leaders and regulatory authorities to develop robust endpoints and biomarkers tailored to the complexities of gastrointestinal diseases. Our Experience S.No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Fosaprepitant & Palonosetron ✔ ✔   ✔ ✔   2 pantraprozole   ✔         3 Esomeprazole   ✔       ✔ 4 Granisetron   ✔   ✔ ✔   5 Famotidine ✔ ✔         6 Omeprazole and Sodium Bicarbonate     ✔ ✔ ✔   7 Study on Gut Microbiome   ✔           Request More Information Submit

Ophthalmology At Techsol Life Sciences, we have the scientific knowledge to accelerate the development of innovative ophthalmic medications and devices. We understand the unique complexities of conducting clinical trials for the eye, and our team of experts possess specialized knowledge and experience to navigate these challenges seamlessly. We are committed to partnering with pharmaceutical and biotechnology companies to bring innovative treatments to patients suffering from vision disorders. How We Can Help Our team of experts possesses unparalleled experience in designing, managing, and executing successful clinical trials across a wide range of ophthalmic indications, with a strong presence in these specific areas: Cataract Surgery: We have extensive experience supporting trials for new cataract surgery techniques, including innovative technologies and devices. Intraocular Lens (IOL) Technology: Our expertise encompasses clinical trials for next-generation IOLs, including trifocal IOLs and other advanced lens designs. Macular Degeneration Treatment: We are well-versed in the complexities of macular degeneration trials, helping sponsors bring promising new treatments to patients. Ophthalmic Instruments: From advanced diagnostic tools to surgical instruments, we have the experience to manage trials for cutting-edge ophthalmic devices. Vision Care Surveys: We offer comprehensive services for conducting vision care surveys to gather valuable patient data and market insights. Beyond these core areas, our expertise extends to a comprehensive range of ophthalmic clinical trials, including: Dry Eye Disease Glaucoma Diabetic Retinopathy Retinal Detachment Corneal Disorder Uveitis By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. We leverage our cutting-edge e-clinical systems and deep ophthalmic knowledge to deliver efficient and cost-effective clinical solutions specifically for ophthalmic devices. Our comprehensive suite of services encompasses the entire clinical trial journey, from feasibility assessments and investigator selection to patient recruitment strategies, regulatory submissions, and post-approval support. This includes expert medical writing, meticulous clinical data management, robust biostatistics & SAS programming, and unwavering vigilance regarding device safety reporting. Our Experience S. No Product Details Techsol’s Contribution Clinical Operations Medical Writing Regulatory Affairs Statistical & Analysis Clinical Data Management PV 1 Bioject -P220 ✔ ✔ ✔ ✔ ✔ ✔ 2 Bio Hydro Cartridge BHC 150   ✔   ✔ ✔   3 Bio-Hydroject Injector     ✔       4 Medicel Accuject   ✔         5 Bioject -P260     ✔       6 IRIS Refractor Device ✔ ✔   ✔ ✔   7 Aflibercept 2 mg (0.05 mL) vial (ZRC-3285)         ✔   8 Keratoplasty (SOTA) Microkeratome, Artificial Chambers, Punches, Trephines, Manipulators, Markers, Speculums, Calipers   ✔ ✔       9 Refractive Surgery (SOTA) Microkeratones, Speculums, Markers, Manipulators   ✔ ✔       10 Bio-Hyalur HV 1.0%   ✔   ✔ ✔   11 Bio-Hyalur HV 2.4%   ✔   ✔ ✔   12 Trifocal Intra Ocular Lens   ✔   ✔ ✔   13 Bioblade   ✔   ✔ ✔   14 Ophthalmic Viscosurgical Device   ✔   ✔     15 Bio-Hyalur Plus 1.4%             16 Drug Delivery System   ✔   ✔ ✔   Request More Information Submit

Our Expertise & Experience Across Therapeutic Areas At Techsol Life Sciences, we understand that every therapeutic area comes with its unique set of challenges and requirements. That’s why we’re dedicated to providing unparalleled expertise across a diverse range of therapeutic areas, empowering you to navigate the complexities of clinical research with confidence. As a Contract Research Organization (CRO) specializing in Biopharma, Medical Devices, Food & Nutraceuticals, we have an experienced medical team who are aligned on the latest scientific developments on different therapeutic areas and indications to deliver scientific value across clinical studies. Our team of dedicated clinical research professionals bring in deep domain knowledge and several years of experience to every project, ensuring precision, efficiency, and ultimately, successful outcomes. How We Can Help Our approach to therapeutic area expertise is rooted in a deep understanding of the specific nuances and intricacies of each field. We combine this knowledge with cutting-edge technology and innovative solutions to deliver tailored strategies that address your most pressing needs. We recognize that no two therapeutic areas are alike, and neither are their challenges. That’s why we take a customized approach to every project, leveraging our therapeutic expertise to develop tailored solutions that align with your unique objectives and goals. Ophthalmology Cardiology Orthopaedics & Rheumatology Oncology Gastroenterology Diabetes & Endocrinology Dermatology Allergy & Immunology Neurology & Psychiatry Urology By collaborating with Techsol, you gain access to tailored solutions designed to meet the unique challenges of your therapeutic area. From protocol design to regulatory compliance, our comprehensive services are tailored to support your trial at every stage. Request More Information Submit

Engage With Us As the platinum sponsor of WDS 2023, Techsol Life Sciences is looking forward to meeting you and your team at this years’ event. Stop by our booth to have a conversation about your business needs and present our solutions. Day – 1 (October 18th, 2023) We are proud to announce that Satya Sagi, Founder & CEO of Techsol Life Sciences will be delivering an insightful presentation on the “Establishing pro-active and real-time pharmacovigilance operations oversight using digitalization & automation to enhance operational efficiency, quality and compliance” at 2:25 PM. Key takeaways: Get introduced to concept of Pharmacovigilance OversightLearn about how to address current PV Operational ChallengesFormulate a roadmap for PV process digitalization, andLearn about the long-term benefits after PV Ops Digitalization & Oversight implementation. During the conference session breaks, you are welcome to attend the following presentations at the Techsol booth. Digitalize and Automate Literature Screening while increasing efficiency and achieving compliance Streamline Drug Safety Aggregate Reporting Through Digitalization AccelSafety – Integrated Drug Safety and Signal Management Solution, Powered By: Oracle Argus The Future of GxP Operations Oversight & Compliance Governance Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Day – 2 (October 19th, 2023) Automation in PSMF is to streamline and enhance the management of safety data. It also enables faster response to safety concerns, ultimately improving patient safety and the quality of pharmaceutical products. Don’t miss this insightful panel discussion with thought leaders from the industry to streamline agreements, exchange, and reconciliation. Topic: How digitalization and automation can enable pharma to establish an audit-ready electronic Pharmacovigilance Systems Master File (ePSMF) Kimary Pomphrett, Associate Vice President, Client Services, Techsol Life Sciences Philisha Mack, Director Drug Safety, Azurity Pharmaceuticals Sriram Varma, Co-Founder & Senior Vice President, Technology & Data, Techsol Life Sciences Matthew Wieczorek, Director / PSMF Lead, Quality Management & Inspections, Pfizer Joe Elicone, Global Business Process and Technology Lead, CSL Behring Learn about our end-to-end, integrated Drug Safety & Pharmacovigilance Technology Solutions and Functional Services that we delivered for more than 80+ clients. Our strategic solution delivery model includes a combination of Oracle Argus Safety, Compier PV Ops platform and SciMax medical affairs platform. Have a chat with our team and send us your requirements and business priorities. We’d be happy to present our unified business solutions that increases quality, compliance, and overall value. Schedule a Meeting With Us Submit

Thanks For Connecting With Us It was a pleasure to meet you at the 2023 MedTech conference! Techsol Life Sciences is an integrated clinical development, medical affairs, and post-marketing surveillance business solutions provider to global medical device companies. We specialize in delivering value-focused MedTech clinical services that include regulatory lifecycle management, EU-MDR / IVDR consulting, medical writing, clinical investigations, biometrics, device vigilance, product certification, device labeling, artwork management and conducting different types of post-marketing and real-world evidence studies. Using our deep-domain scientific expertise, we are a trusted partner for medical device sponsors to navigate through complex regulatory requirements, gather clinical and safety evidence, launch new products, and proactively perform post-market surveillance reporting across different classes of medical devices. Tell Us About Your Business Needs MedTech PIVOT Solutions: Medical Writing & Clinical Affairs Medical Device Product RegistrationRegional Medical Device Clinical Studies (India)Central / Medical MonitoringCER, PER & BER WritingTechnical Files & Dossier PreparationClinical Data ManagementBiostatistics & SAS Programming Device Vigilance & Regulatory Reporting Device Safety Data ManagementLiterature Search & ReviewSafety Report Submissions (PSUR, DSUR, etc.)Medical Device PMCF Plan & ReportsProduct Certification: CE MarkingDevice Labeling & Artwork ManagementEU MDR / IVDR Consulting Your Contact Information: Submit

Connect With Us & Get Lucky Its a pleasure to meet you at this event.   Hope you are having a good time. Did you know that today could be your lucky day?  Don’t miss out on this amazing opportunity to win a JBL Bluetooth Speaker, a high-quality audio device that you can enjoy for years to come. To participate in this exciting giveaway, all you have to do is provide your contact information in the below form.  Thank you for participating and good luck! Contact Information: I want to know more about: TrackWise Implementation & Validation ServicesTrackWise System IntegrationsTrackWise Application Support ServicesQuality Insights GenerationValidation & Assurance Services Other Business Needs (if any):  Submit Learn More About Our Specialized TrackWise QMS Services TrackWise Implementation & Validation Read more TrackWise System Integrations Read more TrackWise EQMS Application Support Read more Quality Insights Generation Read more

Page Not Found We’re sorry, but the page you’re trying to access may have been moved, deleted, or never existed in the first place. Please check the URL you entered and try again. Clinical Explore our Clinical technology and functional solutions. Regulatory Learn more about our capabilities around Regulatory Business Services. Pharmacovigilance Explore our Drug Safety & pharmacovigilance business solutions. Quality Learn about our TrackWise EQMS and IDBS E-workbook solutions. MedTech Explore our end-to-end Medical Device business solutions.  About Us Learn more about our company and our values. If you have any questions or would like to get information about any of our products and services, please send us a message.  Request More Information Submit

PV PIVOT – Simplifying End-to-End Drug Safety & Pharmacovigilance Operations As a pharmaceutical company, you need a proactive pharmacovigilance practice to ensure patient safety and minimize risks across your product portfolio. However, managing PV operations can be a complex and time-consuming task, requiring significant resources and expertise. That’s why outsourcing your PV needs to a specialized service provider can offer significant benefits for your organization. Introducing PV PIVOT “PV PIVOT” is a value-focused business solution that aims to deliver high-quality and regulatory compliant Pharmacovigilance functional services using a powerful combination of subject matterexperts, PV domain knowledge, lean business processes, cost-effective service models coupled withmodern technology. It leverages Techsol’s 14+ years of technology, medical and scientific PV thoughtleadership in an integrated approach to enable superior regulatory compliance and patient safety. By leveraging digitalization, automation, and real-time oversight, our solution eliminates up to 60% of the manual effort required for various PV functions. This means that your team can focus on more strategic tasks, rather than being bogged down by time-consuming and error-prone manual activities. PV Consulting & Functional Services Drug Safety Case Processing Read more Aggregate Safety Reports Read more Literature Monitoring Read more Safety Signal Management Read more QPPV & LPPV Services Read more PSMF Lifecycle Management Read more Medical Device Vigilance Read more PV Risk Management Read more Medical Information Call Center Read more PV Audits & Training Services Read more PV Regulatory Intelligence Read more Solution Features & Benefits With PV PIVOT, you can enjoy centralized oversight and real-time monitoring of your PV operations, ensuring that all activities are in compliance with regulatory requirements and industry best practices. Our platform is also designed to seamlessly integrate with your existing systems, making it easy to implement and use. Moreover, our flexible subscription model allows you to tailor our services to your specific needs, giving you the ability to scale up or down as required. This means that you can benefit from our expertise and technology without having to commit to a long-term contract. Request More Information Submit

Connect With Us & Get Lucky Its a pleasure to meet you at the DIA 2023 event. Hope you are having a good time. Did you know that today could be your lucky day? Don’t miss out on this amazing opportunity to win a JBL Bluetooth Speaker, a high-quality audio device that you can enjoy for years to come. To participate in this exciting giveaway, all you have to do is provide your contact information in the below form. Thank you for participating and good luck! Tell Us About Your Business Needs Biopharma PIVOT Solutions: Clinical & Regulatory Services Scientific And Medical WritingRegional Clinical Operations (India)Medical Monitoring & ReviewANDA/IND Submission SupportSPL conversions and labelling (smPC/UsPI)Literature Summary Reports for Pre INDsProduct RegistrationsImport/Export Licenses Clinical Data & Safety Management Services Clinical Data ManagementBiostatistics & SAS ProgrammingICSR Case ProcessingSafety Reports Writing (PSUR, DSUR, PBRER, etc.)Literature MonitoringAggregate ReportingPSMF Management MedTech PIVOT Solutions: Medical Writing & Clinical Affairs Medical Device Product RegistrationRegional Medical Device Clinical Studies (India)Central / Medical MonitoringCER, PER & BER WritingTechnical Files & Dossier PreparationClinical Data ManagementBiostatistics & SAS Programming Device Vigilance & Regulatory Reporting Device Safety Data ManagementLiterature Search & ReviewSafety Report Submissions (PSUR, DSUR, etc.)Medical Device PMCF Plan & ReportsProduct Certification: CE MarkingDevice Labeling & Artwork ManagementEU MDR / IVDR Consulting Digital Transformation Technology Solutions & Consulting Services GxP System Validation & Assurance ServicesOracle Argus Safety Implementation & SupportOracle Empirica Signal Implementation & SupportCompier PV Ops Management PlatformMedidata Rave EDC – Study Setup & ProgrammingOracle Clinical One EDC – Study Setup & ProgrammingTrackWise Digital eQMS Implementation & SupportPharma Custom Applications DevelopmentLife Sciences Data Analytics & Custom ReportsPharma Process Automation using AIIDBS Polar for Biopharma Lab R&D Automation Your Contact Information: submit Learn More About Our Specialized Services Clinical Read more MedTech Read more Pharmacovigilance Read more Regulatory Read more

Increase Safety Case Management Efficiency by Integrating with Leading Safety Systems Case assignment in safety systems is basically a manual job making it very tedious for the workflow manager to assign cases to individuals. This challenge of case assignment is particularly accentuated in a scenario of globally dispersed teams. Based on the case count and team availability, the workflow manager has to perform a periodic reconciliation of cases’ statuses and then start the process of assigning and re-assigning the cases to ensure their speedy processing. Managers find it extremely difficult to obtain an overview of their team’s productivity and efficiency as there is a lack of insights to help them make their decisions. There is an absence of informative dashboards in the safety systems which are in use. Gaining an overview of the team performance becomes even more complicated when Pharma companies have more than one MAH configured as different tenants in a single safety system or in multiple ones and when a Service Provider is processing cases for multiple Pharma companies on multiple safety databases. Communication Challenges: Effective communication is essential for successful pharmacovigilance case management, and this can be difficult when dealing with multiple MAHs and safety systems. There may be differences in terminology and processes between the different systems, leading to confusion and delays in case management. Resource Allocation: Having multiple MAHs and safety systems can place a significant burden on resources, including staff, budget, and IT infrastructure. Allocating resources to manage cases across multiple systems can be challenging, and it may be necessary to prioritize cases based on their potential impact on patient safety. Introducing Compier ICSR Management Compier ICSR Operations provides digitalization and automation of case assignment along with insights on the case and user progress. Cases can be auto assigned to users thereby reducing the manual work of a workflow manager. Managers are provided with complete insights of the case processing business workflow. They are given information on different insights such as case details, user details and the details of the time taken to process the case. This information helps them assess their team’s productivity and efficiency. Solution Features & Benefits Eliminate lengthy, redundant and error-prone process in assigning safety cases to global PV team members Managers can perform periodic reconciliation of cases’ statuses and re-assign cases for speedy processing WIth Compier, decision makers can assess their team’s productivity and efficiency with operational insights Simplify the overall case processing effort when Pharma companies have more than one MAH configured Gain visibility on case processing outcomes with connected communication and historical tracking Stay informed on reporting delays and other issues that could result as findings during audits and inspections Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier ICSR Management solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier ISCR Ops Management system along with the required system integrations. Is the Compier ICSR Management solution validated? Compier ICSR Management is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier ICSR Management application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier ICSR Management solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo Submit

Compier AE Intake & Integrated Mailbox Pharma companies are required to download files from the EV Web portal and Canada Vigilance based on active substances (not based on the company’s products). Due to this regulatory change, Pharmacovigilance operations at small to mid-size companies are challenged with timely completion of review and submission of huge volumes of ICSRs.  It is must for companies to include these ICSRs in the company’s centralized safety database to comply with other regulatory agencies for expedited reporting. Common Regulatory Intake Challenges  Manual filtering of company specific AE cases from Eudravigilance Web and Canada Vigilance database and completing ICSR intake Lengthy redundant and error-prone process to compile Individual Case Safety Reports (ICSRs) and finish case processing Users have to download multiple excel files from the Canada Vigilance database and apply filters to segregate their company data Poor visibility on case volume processed from these regulatory safety databases with disconnected communication and no historical tracking Lack of awareness on reporting delays and other issues that could result as findings during audits and inspections Introducing Compier Intake & Mailbox Compier Intake enables seamless AE intake, receipt, and triaging from various sources such as PDFs, emails, etc. through automated data point check and import of safety cases directly into the safety database. It also has a built-in Inbox for distribution of safety case related emails to different business partners and vendors. It also enables automated case filtering and ICSR intake from safety data obtained from the Canada Vigilance and Eudravigilance database. Our platform automatically reads the product information from the E2B R3 files (from EV Web) and CSV files (from Canada Vigilance) and auto-creates a valid safety case without any manual intervention. Solution Features & Benefits >   Regulatory Intake provides various, ready to use dashboards and reports to manage the process efficiently. >   Dashboard for total cases processed in a specific time interval with details of success and non-success numbers >   Total number of cases received for a country and processed based on report type >   Multiple trend reports indicating total number of cases reported by time interval, source, product etc >   Reduces manual effort and address the regulatory compliance needs of the pharmacovigilance department. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Intake & Mailbox modules along with the required system integrations. Is the Compier Intake & integrated Mailbox solution validated? Compier Intake & Mailbox modules are part of the PVOps Management platform. All modules are GxP compliant and meet FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier Intake application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Aggregate solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo Submit

Event Description We are thrilled to be a gold sponsor and exhibitor at the 16th Annual ISCR Conference happening in Delhi on Feb 24th and 25th. At Techsol, we are committed to improving patient outcomes through innovative solutions that drive efficiency, safety, and cost-effectiveness in the clinical research and medtech industry. We believe that our expertise and cutting-edge technologies can make a significant difference in the lives of patients around the world. Our clinical research solutions cover a wide range of areas, including clinical trial management, data management, regulatory compliance, and safety reporting. We offer a suite of customizable tools and services that are designed to streamline processes, reduce errors, and enhance the accuracy of clinical data. Our medtech solutions are focused on providing clinicians and patients with advanced medical technologies that improve the diagnosis, treatment, and management of various medical conditions. Our products include state-of-the-art medical devices, diagnostic tools, and telemedicine solutions that are designed to deliver real-time, actionable insights and improve patient outcomes. As a gold sponsor and exhibitor at the 16th Annual ISCR Conference, we are excited to showcase our latest offerings and meet with industry leaders, clinicians, and researchers to discuss the latest trends and developments in the field of clinical research and medtech. If you’re attending the conference, we invite you to visit our booth to learn more about our solutions and how they can help you drive efficiency, safety, and cost-effectiveness in your clinical research or medtech practice. We look forward to seeing you there! Event Details:  Dates: 24 – 25 February 2023 Location: Hotel Pullman, New Delhi Registration Link: http://iscrconference2023.org/ Schedule a Meeting With Our Team Area of Interest *ClinicalMedical DevicesPharmacovigilanceRegulatoryQualityLabs & ManufacturingOthers Submit Our Expertise Biopharma Clinical Services Pharmacovigilance MedTech Solutions

Accelerate Your Biopharma R&D with IDBS Polar, the World’s Best Scientific Process Management Platform Today, the development of new biologics takes almost 10 to 13 years with a cost of more than 1 billion USD to bring to market. To shorten this massive journey, biopharma development teams can leverage the power of connected technology that interfaces with a wide-range of R&D instruments, LIMS, and other electronic devices to achieve faster method development and conduct of experiments. The need of the hour is to harmonize data collection, information sharing, and gaining actionable insights across biopharma processes such as cell-line development, upstream and downstream processing, and bioanalytical development. To address this industry challenge, Techsol has partnered with IDBS which specializes in providing purpose-built software solutions to address the data management challenges prominent across the BioPharma lifecycle and supply chain. IDBS Polar and Skyland PIMS platforms enable customers in research, development and manufacturing to efficiently and compliantly access crticial data and insights to make faster, smarter decisions with greater confidence. Introducing IDBS Polar IDBS Polar, a cloud-based BioPharma Lifecycle Management (BPLM) platform, helps to efficiently execute your processes while curating the data you need to accelerate time to market by tackling the biggest challenges in process design, optimization, scale-up and technology transfer. There are two main applications which are part of the core IDBS Polar platform.  IDBS Polar BioAnalysis enables CROs and biopharma to improve quality and reproducibility, reduce study cycle times and accelerate time-to-market. With 25 years experience, IDBS best practice workflows to optimize quality, data accuracy and operational efficiency for developing methods and conducting experiments. Registration Facilitates Integrated inventory management along with tracking the entire sample lifecycle which results in 50% lesser documentation time. Planning Enable Study Directors and Principal Investigators to define the recipes, procedures and parameters of the methods and assays that will be conducted, ensuring that execution is repeatable. Execution Document the procedures and preparations of bioanalysis, ensuring quality while retaining flexibility. Capture data in a consistent and traceable way, flag exceptions in process for immediate correction or explanation, and log all items used including genealogy tracking Reporting Summarize results across the execution workflows within a study including the calibration curve, quality controls, validation and stability assessment sample. Request a Demo Submit

Leverage our Ready-to-Use Clinical Study Platform with integrated EDC, Medical Coding, CTMS and Drug Safety Applications ‘AccelStudy’ is a full-managed, cloud-based integrated solutions platform designed for  biopharmaceutical and medical device companies to perform clinical data management, trial management, and manage drug safety functions in a single place. Clients can realize significant benefits almost immediately with a ready-to-use, validated and industry recognized application suite. Our flexible pricing model can lower the total cost of ownership. What is Offered with AccelStudy The ‘AccelStudy’ platform has a robust EDC, CTMS and a Drug Safety System which allows clients to centrally manage the entire lifecycle of a clinical study. It also includes the study design support services from Techsol for setting up sites, investigators, study visits and the associated case report forms. Solution Subscription Model >  Clients can subscribe for one study or for multiple studies in a program by selecting only the required modules for their business need >  The technical solution is offered with ancillary services such as Study Build, Edit Checks Programming, Setting up Data Extraction schedules, and developing custom reports >  Additional System integrations with eCOA, IVRS/IWRS, etc. can be optionally selected as part of the subscription Solution FAQs How do we provide the AccelStudy Platform? ‘AccelStudy’ is delivered on a GxP compliant fully-managed cloud platform hosted on Amazon Web Services (AWS) which has security and quality certifications such as ISO 9001, ISO 27001, ISO 27017 and ISO 27018. All ongoing systems validation and preventive maintenance of the AccelStudy platform and associated add-on applications will be managed by Techsol throughout the business lifecycle. Why ‘AccelStudy’ is an ideal choice for Clients? Techsol owns the responsibility for the end-to-end management of all applications Burden of validation & compliance management is significantly reduced Security option with Single sign-on is available Includes all future application version upgrades, dictionary upgrades, and security updates Considerably reduces Total Cost of Ownership (TCO) Request a Demo Submit <br />

Leverage our Specialized Consulting Services for Oracle’s Unified Clinical One Platform The landscape of clinical trials has long suffered from redundancy and inefficiency, often due to isolated data systems, fragmented technologies, and inconsistent operational methods. But imagine a scenario where you design a study once, input data once, and manage every aspect within a single platform. Clinical One emerges as the pioneering solution, uniquely bringing together individuals, workflows, and data to streamline and expedite both present-day and future clinical trials. With Oracle’s Clinical One platform, pharmaceutical sponsors can manage and unify all elements of the Clinical Development Lifecycle in a safe, secure and compliant manner, while also being open, collaborative and adaptive to change. As one of Oracle’s preferred technology partner, we offer best-in-class cloud software implementation validation services to global pharma and life sciences companies. Read Solution Brief Our Specialized Clinical One Professional Services Clinical Study Setup Our team of Oracle certified Clinical One Solution Engineers can execute fast and accurate study design setup with all the data validation rules. With our strong clinical data management and Clinical One application knowledge, we can help sponsors to reduce the time for study database Go-Live. Clinical One External Application Integrations Clinical One supports a wide-range of external application integrations for facilitating data exchange with cross-functional business groups. With our extensive technical expertise, we can setup and validate different types of API and file-based system integrations that are ideal for your business process on the Clinical One platform for increasing operational efficiency. Clinical Site Support Services From the initial study setup to database lock, our team can provide timely support to manage all mid-study changes. Additionally, our service desk can provide assistance to study managers and site personnel with a comprehensive technical and functional support for fulfilling user requests, troubleshooting and resolving incidents, and executing ongoing change management. Custom Reporting and Data Analytics Clinical One allows the integration of external business intelligence and reporting tools. With our technical expertise, we can establish database connectivity and develop powerful custom reports and dashboards for generating valuable insights across the clinical development lifecycle. End-User Training of Clinical One Although Clinical One has built-in training modules, we can deliver process-oriented application training which is tailored according to your internal standard operating procedures. Our training formats are designed to deliver practical hands-on learning experience for each user group. New to Clinical One? Take a Look Take a look at how Oracle’s Clinical One Platform enables  Sponsor Users to easily setup clinical studies, perform randomization, track study supplies, complete source data verification, and timely resolve data queries.  Play Video Request a Demo Submit

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo Submit

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo submit Client Success Stories Business Services Healthcare giant overcomes merger in 2015 Travel & Aviation Focus on core delivers growth for retailer trading Business Services Transformation sparks financial income for all

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo submit Client Success Stories Business Services Healthcare giant overcomes merger in 2015 Travel & Aviation Focus on core delivers growth for retailer trading Business Services Transformation sparks financial income for all

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo submit Client Success Stories Business Services Healthcare giant overcomes merger in 2015 Travel & Aviation Focus on core delivers growth for retailer trading Business Services Transformation sparks financial income for all

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo submit Client Success Stories Business Services Healthcare giant overcomes merger in 2015 Travel & Aviation Focus on core delivers growth for retailer trading Business Services Transformation sparks financial income for all

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo submit Client Success Stories Business Services Healthcare giant overcomes merger in 2015 Travel & Aviation Focus on core delivers growth for retailer trading Business Services Transformation sparks financial income for all

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo submit Client Success Stories Business Services Healthcare giant overcomes merger in 2015 Travel & Aviation Focus on core delivers growth for retailer trading Business Services Transformation sparks financial income for all

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo <br /> Submit

Powerful Insights-driven Technology Platforms to Transform Your Clinical Development Techsol specializes in providing integrated GxP compliant, ready-to-use software platforms for sponsors to streamline data collection, stakeholder collaboration, oversee business processes and gain insights across the clinical development lifecycle. We work with the best-in-class software providers to bring-in next-generation technology to optimize your clinical development path.  Clinical Technology Solutions & Services We help sponsors to leverage the best of integrated Electronic Data Capture platforms to facilitate accurate clinical data collection with built-in medical coding, source data verification, discrepancy management and faster query resolution. Our clinical team has the expertise to execute the following activities: Rapid EDC Study Database Setup (Visits, Subjects, Forms, Logs, etc.) Configure eConsent in EDC Platforms with local language translations Edit Checks Programming for Data Cleaning (Univariate & Multi-variate) Completing mid-study changes in the EDC platform with minimal downtime Setting up Medical Dictionaries (MedDRA, WHO-Drug, SnoMed) Establishing system integrations with ePRO, eCOA and other eSource data Facilitating data export and creating custom reports for tracking DM metrics Our EDC Systems Expertise >  Oracle Clinical / RDC / TMS >  Clinion  >  Viedoc >  Medidata Rave  Explore Our Solutions Electronic Data Capture, eConsent & RTSM We help sponsors to leverage the best of integrated Electronic Data Capture platforms to facilitate accurate clinical data collection with built-in medical coding, source data verification, discrepancy management and faster query resolution. Clinical Trial Management System & Site Payments Emerging biopharma, device manufactures, and contract research organizations can leverage our AccelCTMS cloud solution to plan, manage and track early to late-stage clinical trials. It enables holistic management of critical clinical trial activities from study start to site close-out for global studies. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo Submit

Leverage the Power of Digital Safety Data Exchange Agreements and Streamline Partner Oversight Market Authorization Holders (MAHs) outsource a wide-range of PV business process functions to partners and vendors for safety data management. This involves drafting a comprehensive PV Agreement that describes all contractual and legal obligations that must be fulfilled by multiple partners and vendors for different products and safety programs.  Common Challenges faced by MAH Representatives Inefficiencies in identifying suitable partners and vendors without a centralized partner database Lack of historical performance measures to qualify partners and vendors for future engagements Long time to define scope, responsibilities, acceptable contractual terms and draft complex agreements due to lack of pre-defined PVA templates Delays in completing the agreement review and sign-off with manual sharing of documents Poor visibility on ongoing partner and vendor engagements without the provision to track SLA timelines and compliance adherence Lack of awareness on potential operational risks and PVA non-compliance issues that could result as findings during audits and inspections Introducing Compier Agreements Compier Agreements facilitates the end-to-end digital lifecycle management of all SDEA / PV Agreements across your global safety programs. For each agreement, you can easily configure the scope, milestones, partner activities and responibilities with the relevant quality, risk and timeline measures to proactively track, and oversee partner PVA compliance. Solution Features & Benefits Centralized Partner Data Management Create Partners and Vendors only once and manage all related contracts in Compier Agreements. This enables easy real-time tracking of all partner engagements in one place.  Templatized Digital PVA Authoring & Versioning Complete faster authoring of PVA agreements using reusable pre-configured templates and checklists. All documents are fully version controlled and managed securely with user-role permissions. Collaborative PVA Review and Approval Initiate real-time collaborative agreements review and approval with multiple team members for fast and smooth digital sign-off with electronic signatures. SLA Definition and Tracking Configure multiple Service Level Agreement measures for each agreement to track partner’s activity timelines and overall compliance adherence Integration with Exchange Tracker Perform real-time tracking of all inbound and outbound cases shared and managed by each Partner using the out-of-the-box integration with the Case Exchange Tracker. Automated Safety Data Exchange Reconciliation Compier automatically performs safety data exchange reconciliation across partners based on periodicity definition. Time compliance and data quality of exchanged case data can be tracked and monitored with built-in reports and dashboards. Correspondence and Collaboration Leverage the built-in centralized Compier mail inbox which streamlines all stakeholder communication and information exchange between MAH and partners. Process Alerts & Notifications Proactively address all operational issues and stay informed on the progress of all partner activities through configurable system alerts and notifications.  Process Insights & Partner Oversight Gain comprehensive actionable operational insights for informed decision making. Importanly, the built-in PVA specific SLA Reports and KPI dashboards allows MAH to perform partner oversight. Solution FAQs How is the Compier solution provided by Techsol? We offer the Compier PV Agreements solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier PV Agreements system along with the required system integrations. Is the Compier PV Agreements solution validated? Compier Agreements is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.  What kind of training is provided for Compier? Our subject matter experts will deliver a hands-on Compier PV Agreements application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations. Can the platform support external system integrations? The Compier PV Agreements solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity. The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions. Request a Demo Submit

Leverage Our Expertise for End-to-End Clinical Development & Data Management As a full-range clinical research services provider, we have delivered scientific process solutions to several multi-national sponsor companies across different therapeutic areas using our highly experienced team of Scientists, Biostatisticians, and other Medical Professionals. Our Quality Certifications We always strive towards delivering products and services with the highest quality by adhering to best practices, global standards and applicable regulations. As an organization, we have ISO 9001:2015, ISO 27001, ISO 14155:2011 and ISO 13485:2016 certifications to account for GxP Quality and Compliance. Techsol’s Clinical PIVOT Framework With our 20+ years of combined team experience, sponsors have entrusted us as a reliable CRO partner  because of our unwavering focus on patient safety, regulatory compliance and data quality. With our domain expertise, we have a well-established clinical operations team for managing the conduct of pre-clinical studies to post-marketing surveillance.  Dedicated Experienced Team with Scientific & Regulatory Knowledge 100% Quality and Compliance focused Clinical Trial Operations Leveraging best-in-class technology for close-knit collaboration Flexible Global Service Delivery Models to remove cost-burden Proactive Process Operations Oversight to eliminate risks Generating Actionable Insights for informed decision making Therapeutic Expertise Oncology Respiratory Infectious Diseases Oncology Cardiology Gastroenterology Nephrology Diabetes Obstetrics & Gynecology Urology Dermatology Ophthalmology Neurology Parental nutrition Services We Offer Scientific And Medical Writing Read more Clinical Operations and Study Monitoring Read more Clinical Data Management Read more Biostatistics & SAS Programming Read more Regulatory Affairs Read more Drug Safety And Pharmacovigilance Read more Regulatory Lifecycle Management Read more Launch & Commercialization Read more Data Safety Monitoring Board Read more Medical Monitoring & Review Read more Request for More Information Submit

Event Highlights Techsol is excited to announce its participation as Platinum Sponsor and Exhibitor at the World Drug Safety Congress Americas 2021. We look forward to meeting you and your team at Booth# 26 to have a conversation about your business needs and present our solutions. Day – 1 (October 20th, 2021) We shall be introducing Compier, our latest AI-powered innovation that enables comprehensive GxP Operations and Compliance Oversight. The event will take place at Booth# 26 at 12:30 PM during the lunch break. During the unveil, our team will be presenting a quick demo of several automation modules such as Literature Screening, Aggregate Reporting, SDEA Management, ICSR Processing, and so on to showcase the platform’s value-generation capabilities. Day – 2 (October 21st, 2021) Our CEO, Satya Sagi is presenting an insightful topic on the use of Artificial Intelligence, Machine Learning & Automation for Pharmacovigilance Literature Management between 11:00 AM to 11:20 AM EST. He will be discussing how Human-Driven AI Automation Simplifies Global Literature Screening. The second part of the talk will be focused on handling Large Volume of Structured and Unstructured Data with the Power of AI & NLP and he will conclude with optimizing AI-based Literature Search Capability with Advanced Machine Learning & Analytics. Stop by Booth#26 to know more about our Pharmacovigilance Solutions (Oracle Argus Safety), Compier Platform, Clinical & Data Services and other Scientific Process Solutions. Our team will be happy to present a personalized solution tour and you can also get to win exciting giveaways. Let us Know How We Can Help submit

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About Us Techsol Life Sciences is an integrated clinical development, medical affairs and post-marketing surveillance business solutions provider to global biopharmaceutical, medical device, food, and nutraceuticals companies. With our commitment to bringing novel treatments and therapies faster to market, we deliver regulatory compliant clinical research services, GxP technology consulting solutions in combination with our unified SaaS platforms. Using our deep-domain scientific expertise and technology innovation, we help sponsors to reduce time-to-market, save costs, and realize maximum value, across pharmaceutical and medical device business functions through clinical research, compliance oversight, insights generation, digitalization and GxP process automation. Our Business Solutions Datasheets AccelSafety (Integrated Drug Safety, Regulatory Reporting & Signal Management Platform) Drug Safety & PV Functional Services Honeywell Sparta TrackWise QMS – System Integrations & Technology Consulting Serivces Compier PV Ops Platform Validation & Assurance Services Biopharma Clinical & Data Services MedTech Clinical & Regulatory Consulting Services Get in Touch With Us submit

Cookie Policy Last updated: 18th November, 2021 This Cookie Policy explains how Techsol Life Sciences (“Techsol“, “we“, “us“, and “ours“) use cookies and similar technologies to recognize you when you visit our website at www.techsollifesciences.com, (“Website“). It explains what these technologies are and why we use them, as well as your rights to control our use of them. In some cases, we may use cookies to collect personal information, or that becomes personal information if we combine it with other information. In such cases, our Privacy Policy (www.techsollifesciences.com/privacy-policy) will apply in addition to this Cookie Policy. What are cookies? Cookies are small data files that are stored on your computer or mobile device when you visit a website. Cookies are widely used by website owners to make their websites work, or to work more efficiently, to provide reporting information and for personalized/targeted advertising. Cookies set by the website owner (in this case, Techsol) are called “first party cookies”. Cookies set by parties other than the website owner are called “third party cookies”. Third party cookies enable third party features or functionality to be provided on or through the website (e.g. advertising, interactive content, and analytics). The parties that set these third-party cookies can recognize your computer both when it visits the website in question and also when it visits certain other websites. Why do we use cookies? We use first and third-party cookies for several reasons. Some cookies are required for technical reasons to operate our Website, and we refer to these as “essential” or “strictly necessary” cookies. Other cookies also enable us to track and target the interests of our users to enhance the experience on our Websites, applications and other platforms (“Online Properties“). Third parties serve cookies through our Websites for advertising, analytics and other purposes. This is described in more detail below. The specific types of first and third-party cookies served through our Websites and the purposes they perform are described below (please note that the specific cookies served may vary depending on the specific Online Properties you visit): Analytics and customization cookies: These cookies collect information that is used either in aggregate form to help us understand how our Website are being used or how effective our marketing campaigns are, or to help us customize our Websites for you.   Name Provider Purpose Duration _ga https://developers.google.com/analytics/devguides/collection/analyticsjs/cookie-usage To analyze Website usage and for Website customization. 2 Years Name Provider Purpose Duration _gid https://developers.google.com/analytics/devguides/collection/analyticsjs/cookie-usage Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website’s performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. 1 day Name Provider Purpose Duration YSC https://developers.google.com/analytics/devguides/collection/analyticsjs/cookie-usage YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. Session Name Provider Purpose Duration _gat https://developers.google.com/analytics/devguides/collection/analyticsjs/cookie-usage This cookie is installed by Google Universal Analytics to restrain request rate and thus limit the collection of data on high traffic sites. Session How to refuse: To refuse these cookies, please follow the instructions below under the heading “How can I control cookies?”. Alternatively, please visit the following opt-out link: https://support.google.com/analytics/answer/181881?hl=en Strictly Necessary Cookies: These cookies are necessary for the Online Properties to function and cannot be turned off in our systems. They are usually only set in response to actions you take which amount to a request for services, such as setting your privacy preferences, logging in, or filling out forms. You may be able to set your browser to block or alert you about some of these cookies. However, if you block these cookies some parts of our Online Properties will not work. Name Provider Purpose Duration PHPSESSID Techsol (first-party cookie) This is a cookie generated by applications based on the PHP language. It is a general-purpose identifier used to maintain user session variables. Session Name Provider Purpose Duration cookielawinfo-checkbox-necessary Techsol (third-party cookie) Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the “Necessary” category. 1 Year Name Provider Purpose Duration cookielawinfo-checkbox-functional Techsol (third-party cookie) Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the “Necessary” category. 1 Year Name Provider Purpose Duration cookielawinfo-checkbox-performance Techsol (third-party cookie) Set by the GDPR Cookie Consent plugin, this cookie is used to store the user consent for cookies in the category “Performance”. 1 Year Name Provider Purpose Duration cookielawinfo-checkbox-analytics Techsol (third-party cookie) Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the “Analytics” category . 1 Year Name Provider Purpose Duration cookielawinfo-checkbox-advertisement Techsol (third-party cookie) Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the “Advertisement” category . 1 Year Name Provider Purpose Duration cookielawinfo-checkbox-others Techsol (third-party cookie) This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category “Others”. 1 Year How to refuse: To refuse these cookies, please follow the instructions below under the heading “How can I control cookies?“. Performance Cookies:These cookies allow us, among other things, to count Online Properties visits and traffic sources so we can measure and improve the performance of our Online Properties. They help us to know which pages are the most – and least – popular, and see how you move around the Online Properties. If you do not allow these cookies, we will not know when you have visited our Online Properties and will not be able to monitor our Online Properties’ performance. Name Provider Purpose Duration _gat Techsol (first-party cookie) This cookie is associated with Google Universal Analytics. According to available documentation, it is used to throttle the request rate – limiting the collection of data on high traffic sites. 10 minutes How to refuse: To refuse these cookies, please follow the

Jurisdiction Specific Terms Last Modified: [07-June-2024] These Jurisdiction Specific Terms (the “Jurisdictional Terms”) and its Annexes are supplemental to and forms an integral part of the Data Processing Addendum (the “Addendum”), a schedule to the Techsol Master Licenses and Service Agreement (the “Service Agreement”). These Jurisdictional Terms are effective upon its incorporation into the Addendum. Techsol reserves the right to update these Jurisdictional Terms from time to time by posting a revised version at https://www.techsollifesciences.com/jurisdiction-specific-terms/. To the extent Techsol processes Client Personal Data originating from, or otherwise protected by Applicable Laws, in one of the jurisdictions listed in these Jurisdictional Terms, these Jurisdictional Terms will apply in addition to the terms of the Addendum. In the event of any conflict or ambiguity between these Jurisdictional Terms and any terms of the Addendum, the applicable Jurisdictional Terms will take precedent. Terms not otherwise defined in these Jurisdictional Terms will have the meaning as set forth in the Addendum. 1. European Economic Area. 1.1. “European Economic Area” or “EEA” means the EU Member States, and Iceland, Liechtenstein, and Norway. 1.2. “EU 2021 Standard Contractual Clauses” means the contractual clauses adopted by the Commission Implementing Decision (EU) 2021/914 of 4 June 2021 on standard contractual clauses for the transfer of personal data to third countries pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council 1.3. “Restricted Transfer of EEA Personal Data” means any transfer of Client Personal Data Subject to the GDPR which is undergoing Processing or is intended for Processing after transfer to Third Country (as defined below) or an international organization Third Country (including data storage on foreign servers). 1.4. “Third Country” means a country outside of the EEA. 1.5. With regard to any Restricted Transfer of EEA Personal Data from the Client to Techsol within the scope of the Addendum, one of the following transfer mechanisms shall apply, in the following order of precedence: a) a valid adequacy decision adopted by the European Commission on the basis of Article 45 of the GDPR that provides that the Third Country, a territory or one or more specified sectors within that Third Country, or the international organization in question to which Client Personal Data is to be transferred ensures an adequate level of data protection; b) Techsol’s EU-U.S. Data Privacy Framework Certification, or any successor to the Data Privacy Framework, only to the extent that any such certification constitutes an “appropriate safeguard” pursuant to Article 46 of the GDPR and provided further that the Services are covered by the certification, if applicable; c) the EU 2021 Standard Contractual Clauses (insofar as their use constitutes an “appropriate safeguard” under Article 46 of the GDPR); or d) any other lawful data transfer mechanism, as laid down in Chapter 5 of the GDPR, as the case may be. 1.6. In the event that a Restricted Transfer of EEA Personal Data can be covered by more than one transfer mechanism under Section 1.5 of these Jurisdictional Terms, the transfer of Personal Data will be subject to a single transfer mechanism in accordance with the order of precedence set forth in Section 1.5. For the avoidance of doubt, the EU 2021 Standard Contractual Clauses shall not apply to any Restricted Transfer of EEA Personal Data covered by Techsol’s EU-U.S. Data Privacy Framework certification or similar self-certification, as described in Section 1.5(b). 1.7. EU 2021 Standard Contractual Clauses: a) These Jurisdictional Terms hereby incorporates by reference the EU 2021 Standard Contractual Clauses (updated from time to time if required by law or at the choice of Techsol to reflect the latest version promulgated by the European Commission). The Parties are deemed to have accepted, executed, and signed the EU 2021 Standard Contractual Clauses where necessary, in their entirety (including the annexes thereto). b) The content of Annex I and Annex II of the EU 2021 Standard Contractual Clauses is set forth in Exhibit A of the Addendum. The content of Annex III of the EU 2021 Standard Contractual Clauses is set forth at: https://www.techsollifesciences.com/techsol-data-subprocessors. c) The text contained in Annex I to these Jurisdictional Terms supplements the EU 2021 Standard Contractual Clauses. d) The Parties agree to apply the following modules: i) Module Two of the EU 2021 Standard Contractual Clauses when, in accordance with Section 3.1 of the Addendum, Client acts as the “data exporter” and Controller and Techsol acts as the “data importer” and Processor; and i) Module Three of the EU 2021 Standard Contractual Clauses when, in accordance with Section 3.1 of the Addendum, Client acts as the “data exporter” and Processor and Techsol acts as the “data importer” and sub-Processor. e) For purposes of Annex I.A: i) The Parties have provided each other with the identity and contact information required under Annex I.A. i) The Parties’ controllership roles are set forth in Section 3.1 of the Addendum. f) With respect to Clause 9 of the EU 2021 Standard Contractual Clauses, the Parties select “Option 2: General Written Authorization” and the time period set forth in Section 6.3 of the Addendum. g) For purposes of Annex I.C and with respect to Clause 13 of the EU 2021 Standard Contractual Clauses: i) where Client is established in an EU Member State, the competent supervisory authority shall be the authority for the EU Member State in which Client is established, as indicated in Section 17 of Exhibit A of the Addendum; i) where Client is not established in an EU Member State, but has appointed a representative in an EU Member State pursuant to Article 27(1) of the GDPR, the competent supervisory authority shall be the authority for the EU Member State in which such representative has been appointed, as indicated in Section 18 of Exhibit A of the Addendum; or i) where Client is not established in an EU Member State and has not appointed a representative in an EU Member State pursuant to Article 27(1) of the GDPR, the competent supervisory authority shall be as indicated in Section 19 of