Drug Safety Archives - Techsol Life Sciences https://www.techsollifesciences.com/casestudy_category/drug-safety/ Navigate To Excellence Tue, 09 Sep 2025 05:34:22 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.2 https://www.techsollifesciences.com/wp-content/uploads/2022/12/cropped-techsol-life-sciences-favicon-32x32.png Drug Safety Archives - Techsol Life Sciences https://www.techsollifesciences.com/casestudy_category/drug-safety/ 32 32 Specialized Regulatory Writing Solutions for Clinical Overviews in Combination Therapy Submissions https://www.techsollifesciences.com/case-studies/specialized-regulatory-writing-solutions-for-clinical-overviews-in-combination-therapy-submissions/ Thu, 01 May 2025 05:43:40 +0000 https://www.techsollifesciences.com/?page_id=21529 Specialized Regulatory Writing Solutions for Clinical Overviews in Combination Therapy Submissions   Category: A Product targeting type 2 Diabetes Geography: Global Product Type: Drug Therapeutic Area: CTD Module Background/Client Requirement: The client is an India-based pharmaceutical company that manufactures a wide range of drugs across various therapeutics areas. With a strong market presence, the company is deeply committed to upholding ethical standards and moral values in all its business operations. The client outsourced Techsol for drafting clinical overview (Module 2.5) for a Type 2 anti-diabetic drug, ensuring alignment with international regulatory requirements. ensuring alignment with international regulatory requirements. Project Aim:  The aim of the project was to develop a comprehensive, regulatory-compliant clinical overview for Type 2 anti-diabetic drug to support the client’s submission to international regulatory authorities. The clinical overview needed to be effectively demonstrate the drug’s efficacy, safety, and therapeutic benefits while aligning with the client’s commitment to ethical standards and regulatory requirements, ultimately facilitating a streamlined and successful approval process.Techsol Approach:   Techsol adopted structured and evidence-based apprach to understand the client’s regulatory, clinical, and ethical needs, including an in-depth review of the anti-diabetic drug’s therapeutic profile, highlighing the need for the efficacy, safety and pharmacological data. A comprehensive literature review was conducted, focusing on Type 2 diabetes management and current treatment trends. Using structured templates in line with ICH guidelines, the team drafted the clinical overview, incorporating detailed sections on pharmacology, clinical efficacy, and safety. Techsol’s internal quality assurance (QA) processes ensured each draft adhered to regulatory standards. Regular checkpoints were scheduled to review progress with the client, resulting a robast clinical overview. Challenges:   Drafting a clinical overview for a combination of drugs of Type 2 anti-diabetics in the Common Technical Document (CTD) Module 2.5 involves several significant challenges. Complexity of Data: Integrating the data from multiple sources, including clinical studies and real-world evidence, presented a challenge in maintaining a cohesive narrative on efficacy and safety.  Regulatory Compliance: As the drug was intended for international markets, it was essential to meet diverse regulatory requirements was challenging, particularly those of the US FDA, EMA, and CDSCO. Ensuring compliance across these regions required meticulous attention to guideline details.  Time Constraints: The project was on a tight timeline, given the client’s planned submission schedule. Solutions:   Structured Drafting Approach: A structured approach was adopted, segmenting the clinical overview into sections (e.g., efficacy, safety, pharmacokinetics) to facilitate concurrent drafting and review. This allowed the team to expedite the process without compromising with content quality.  Cross-Functional Team Collaboration: Techsol expert clinical pharmacologists, regulatory writers, and quality assurance teams along with medical writing teams enabled efficient data handling, compliance adherence, and expedited reviews.  Data Curation: Techsol medical writing teams utilized existing clinical data from monotherapy trials of each drug to support the combination’s profile. Incorporated meta-analyses of published studies and real-world evidence to supplement clinical trial data. This reduced the duplicate studies and expediated the regulatory process.   Document Management Tools: Techsol has adopted to the client’s document management tools, enabling real-time document sharing with the client and version control to track changes. This also enhanced data security and streamlined feedback integration.   Dedicated Project Management: A dedicated project manager ensured that timelines were adhered to and served as the primary liaison between the client and Techsol’s team.   Regulatory Intelligence: Conducted comprehensive regulatory intelligence, ensured to understand the specific requirements and guidelines of target markets. This includes monitoring regulatory changes and trends.   Ensured that the clinical overview and supporting documents were comprehensive, clearly written, and provided robust justification for the combination therapy’s safety and efficacy. Project Achievements:Techsol successfully delivered a high-quality clinical overview within the client’s tight deadline, cloud met their submission requirements on time. The document was meticulously crafted to comply with the regulatory standards, aligning the client’s submission with international guidelines. The client expressed satisfaction with the quality, professionalism, and thoroughness of the clinical overview, recognizing Techsol’s expertise in regulatory document preparation. Project Outcome:By implementing these solutions, the client was able to navigate the complexities in drafting a clinical overview for combination therapies more effectively, ensuring thorough documentation of safety and efficacy while meeting diverse regulatory requirements. This successful project outcome not only fulfilled the client’s immediate needs but also reinforced a strong client-consultant relationship, paving the way for future collaborations.  Our Medical Writing Capabilities: We ensure regulatory compliance, delivering high-quality content that instills confidence in our clients’- medical communication endeavors. Our team of medical writing experts comprehensive knowledge across various therapeutic areas, ensure precise and accurate communication designed to specific healthcare needs. Our expertise and Impeccable domain knowledge ensure accuracy, credibility, and professionalism. Talk to an Expert Company overview Quality Accreditations Meet Our Team Our history Industry Partners Careers how can we help you? Contact us at the Consulting WP office nearest to you or submit a business inquiry online. contacts Submit

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Specialized Regulatory Writing Solutions for Clinical Overviews in Combination Therapy Submissions  

Category:  A Product targeting type 2 Diabetes  
Geography: Global
Product Type: Drug
Therapeutic Area: CTD Module

Background/Client Requirement:

The client is an India-based pharmaceutical company that manufactures a wide range of drugs across various therapeutics areas. With a strong market presence, the company is deeply committed to upholding ethical standards and moral values in all its business operations. The client outsourced Techsol for drafting clinical overview (Module 2.5) for a Type 2 anti-diabetic drug, ensuring alignment with international regulatory requirements. ensuring alignment with international regulatory requirements.

Project Aim: 

The aim of the project was to develop a comprehensive, regulatory-compliant clinical overview for Type 2 anti-diabetic drug to support the client’s submission to international regulatory authorities. The clinical overview needed to be effectively demonstrate the drug’s efficacy, safety, and therapeutic benefits while aligning with the client’s commitment to ethical standards and regulatory requirements, ultimately facilitating a streamlined and successful approval process.
Techsol Approach:  

Techsol adopted structured and evidence-based apprach to understand the client’s regulatory, clinical, and ethical needs, including an in-depth review of the anti-diabetic drug’s therapeutic profile, highlighing the need for the efficacy, safety and pharmacological data. A comprehensive literature review was conducted, focusing on Type 2 diabetes management and current treatment trends. Using structured templates in line with ICH guidelines, the team drafted the clinical overview, incorporating detailed sections on pharmacology, clinical efficacy, and safety. Techsol’s internal quality assurance (QA) processes ensured each draft adhered to regulatory standards. Regular checkpoints were scheduled to review progress with the client, resulting a robast clinical overview.

Challenges:  

Drafting a clinical overview for a combination of drugs of Type 2 anti-diabetics in the Common Technical Document (CTD) Module 2.5 involves several significant challenges.

  • Complexity of Data: Integrating the data from multiple sources, including clinical studies and real-world evidence, presented a challenge in maintaining a cohesive narrative on efficacy and safety. 
  • Regulatory Compliance: As the drug was intended for international markets, it was essential to meet diverse regulatory requirements was challenging, particularly those of the US FDA, EMA, and CDSCO. Ensuring compliance across these regions required meticulous attention to guideline details. 
  • Time Constraints: The project was on a tight timeline, given the client’s planned submission schedule.
Solutions:  
  • Structured Drafting Approach: A structured approach was adopted, segmenting the clinical overview into sections (e.g., efficacy, safety, pharmacokinetics) to facilitate concurrent drafting and review. This allowed the team to expedite the process without compromising with content quality. 
  • Cross-Functional Team Collaboration: Techsol expert clinical pharmacologists, regulatory writers, and quality assurance teams along with medical writing teams enabled efficient data handling, compliance adherence, and expedited reviews. 
  • Data Curation: Techsol medical writing teams utilized existing clinical data from monotherapy trials of each drug to support the combination’s profile. Incorporated meta-analyses of published studies and real-world evidence to supplement clinical trial data. This reduced the duplicate studies and expediated the regulatory process.  
  • Document Management Tools: Techsol has adopted to the client’s document management tools, enabling real-time document sharing with the client and version control to track changes. This also enhanced data security and streamlined feedback integration.  
  • Dedicated Project Management: A dedicated project manager ensured that timelines were adhered to and served as the primary liaison between the client and Techsol’s team.  
  • Regulatory Intelligence: Conducted comprehensive regulatory intelligence, ensured to understand the specific requirements and guidelines of target markets. This includes monitoring regulatory changes and trends.  
Ensured that the clinical overview and supporting documents were comprehensive, clearly written, and provided robust justification for the combination therapy’s safety and efficacy.

Project Achievements:
Techsol successfully delivered a high-quality clinical overview within the client’s tight deadline, cloud met their submission requirements on time. The document was meticulously crafted to comply with the regulatory standards, aligning the client’s submission with international guidelines. The client expressed satisfaction with the quality, professionalism, and thoroughness of the clinical overview, recognizing Techsol’s expertise in regulatory document preparation.

Project Outcome:
By implementing these solutions, the client was able to navigate the complexities in drafting a clinical overview for combination therapies more effectively, ensuring thorough documentation of safety and efficacy while meeting diverse regulatory requirements. This successful project outcome not only fulfilled the client’s immediate needs but also reinforced a strong client-consultant relationship, paving the way for future collaborations. 

Our Medical Writing Capabilities:

  • We ensure regulatory compliance, delivering high-quality content that instills confidence in our clients’- medical communication endeavors.
  • Our team of medical writing experts comprehensive knowledge across various therapeutic areas, ensure precise and accurate communication designed to specific healthcare needs.
  • Our expertise and Impeccable domain knowledge ensure accuracy, credibility, and professionalism.

Talk to an Expert

how can we help you?

Contact us at the Consulting WP office nearest to you or submit a business inquiry online.

contacts
[contact-form-7]

The post Specialized Regulatory Writing Solutions for Clinical Overviews in Combination Therapy Submissions appeared first on Techsol Life Sciences.

The post Specialized Regulatory Writing Solutions for Clinical Overviews in Combination Therapy Submissions appeared first on Techsol Life Sciences.

]]> Over coming challenges in drafting region-specific clinical summaries https://www.techsollifesciences.com/case-studies/over-coming-challenges-in-drafting-region-specific-clinical-summaries/ Mon, 14 Apr 2025 06:19:48 +0000 https://www.techsollifesciences.com/?page_id=21334 < Read All Case Studies Overcoming Challenges in Drafting Region Specific Clinical Summaries Category: ASEAN Common Technical Documents Geography: Brazil Product Type: Drug Therapeutic Area: Neurology Background/Client Requirement: A global pharmaceutical client with a portfolio of more than 200 products in India and exports across Asia, Africa, and the Middle East, committed to improving public health through high-quality research and healthcare initiatives. As the client pursues global expansion, they faced regulatory challenges. To address these, the client engaged Techsol Lifesciences to create a region-specific ASEAN Common Technical Document (ACTD) clinical summary, ensuring compliance with submission requirements for the Brazilian Health Regulatory Agency (ANVISA).  Project Objective:  The aim was to prepare a comprehensive clinical summary (Module 2.7) for an epilepsy drug, following ASEAN Common Technical Document (ACTD) guidelines for submission to the Brazilian Health Regulatory Agency (ANVISA), ensuring that the clinical data complied with ACTD guidelines and was adaptable for ANVISA submission.   Techsol Approach:   Drafting region-specific clinical summaries for drugs targeting conditions such as epilepsy demands scientific rigor and deep understanding of regulatory requirements and patient perspectives across regions. This involves preparing a compliant, accurate clinical summary that meets ANVISA’s requirements, ensuring successful submission and marketing authorization in Brazil. Techsol’s approach began with a thorough gap analysis of ANVISA’s submission guidelines, focusing on clinical documentation requirements for submission in Brazil. A cross-functional team of medical writers, and regulatory affairs specialists collaborated to ensure the clinical summary accurately reflected clinical trial results while aligning with regulatory expectations. Summarizing Clinical data from Phase I-III trials on efficacy, safety, and statistical significance as per ACTD guidelines. Multiple reviews of the document were done internally to ensure scientific accuracy and regulatory compliance. Challenges: Drafting the Clinical Summary (Module 2.7) comes with unique challenges.Here are some challenges:  Data Harmonization across Regions: ASEAN guidelines for clinical summaries emphasize the importance of summarizing clinical data on efficacy, safety, pharmacokinetics, and pharmacodynamics data from Southeast Asian populations for ANVISA, aligning with Brazil’s regulatory and ICH standards.  Regional Variability in Disease Epidemiology: The prevalence and treatment response of epilepsy and migraine vary by region. Brazil has distinct epidemiological profiles for these conditions, requiring additional data to confirm the relevance of trial outcomes for Brazilian patients.   Gap Analysis: Addressing gaps in the available data and finding alternative ways to mitigate the issues without compromising the integrity of the clinical summary. The client lacked adequate data on the drug’s bioavailability and bioequivalence.  Balancing Conciseness with Completeness: The clinical summary had to be concise enough for regulatory reviewers while providing all necessary clinical data and analysis. Striking the right balance between brevity and detail was challenging.  Complexity of Data Interpretation: The clinical trial data were extensive, involving multiple patient groups and endpoints. Interpreting the data in a way that would be clear to regulatory reviewers, while maintaining scientific accuracy, posed a challenge.  Adherence to ANVISA Guidelines: ANVISA’s guidelines required a high level of detail and specific formatting, which demanded careful attention to the regulatory submission requirements to ensure complaince   Solutions: To overcome the challenges in preparing the ACTD document, Techsol’s MW Team adopted a multiple strategies. Data Harmonization across Regions: To address the challenge of harmonizing clinical data across regions, Techsol’s Medical Writing team conducted a thorough literature review of clinical data from Southeast Asian populations, ensuring that efficacy, safety, pharmacokinetics, and pharmacodynamics data were relevant and aligned with ICH standards and Brazil’s regulatory expectations, with close collaboration between regulatory experts from Brazil.  Regional Variability in Disease Epidemiology: A region-specific literature search and real-world evidence from local studies provided up-to-date epidemiological data on epilepsy and migraine in Brazil, supporting the relevance of ASEAN clinical data ensuring that trial outcomes and treatment strategies were applicable to Brazilian patients. Gap Analysis: Techsol Medical Writing brings extensive expertise in utilizing alternative data sources and methodologies to address gaps in data on the drug’s bioavailability and bioequivalence. By employing approaches such as population pharmacokinetic modeling and supplementary studies, Techsol ensures these gaps are effectively mitigated while upholding the integrity of the clinical summary. Balancing Conciseness with Completeness: A rigorous process was followed to ensure that the clinical summary was concise without sacrificing necessary detail. Key data points were prioritized, and a structured approach to the presentation of information was adopted to streamline content while maintaining clarity. This included focusing on high-level summaries of efficacy and safety data, with detailed supporting data included in appendices or supplementary documents.  Complexity of Data Interpretation: Techsol’s in-house clinical data analysts, medical reviewers, biostatisticians, and regulatory experts collaborated closely with medical writers to interpret the extensive trial data accurately and ensure alignment with study objectives. Data were organized into clear visual formats including, tables, graphs, and summary statistics, with, key findings highlighted, and complex analyses were simplified to aid regulatory reviewers in understanding the data’s implications. Adherence to ANVISA Guidelines: A detailed review of ANVISA’s submission guidelines was performed to ensure that clinical summary was in full adherence. Compliance checklists were created, and the submission document underwent multiple rounds of internal reviews to confirm that every aspect of the guidelines was met, including the inclusion of necessary appendices and supplementary documents.  Project Achievements:  Techsol’s medical writing team’s expertise and commitment resulted in crafting a high-quality clinical summary within timelines. The document met ANVISA’s regulatory requirements and adhered to the ACTD structure, ensuring a smooth submission process in line with international standards. The clear articulation of patient-centered outcomes, supported by real-world evidence, made the summary relevant to Brazilian clinical practices. ANVISA responded favourably, and the review process proceeded smoothly.  Project Outcomes: Techsol’s structured approach resulted in a compliant clinical summary, yielding the following key outcomes: Successful Regulatory Alignment: ANVISA accepted the submission, and the clinical summary was effectively supported the agency’s evaluation of the drug’s efficacy and safety profile, resulting in minimal delays.  Market Expansion and Patient Impact: The drug received marketing authorization in Brazil, enabling the client to commercialize the new treatment for epilepsy and migraine in the Brazilian market. This authorization opened new business opportunities and provided an essential

The post Over coming challenges in drafting region-specific clinical summaries appeared first on Techsol Life Sciences.

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< Read All Case Studies

Overcoming Challenges in Drafting Region Specific Clinical Summaries

📌 Category: ASEAN Common Technical Documents
🌍 Geography: Brazil
💊 Product Type: Drug
🧠 Therapeutic Area: Neurology

Background/Client Requirement:

A global pharmaceutical client with a portfolio of more than 200 products in India and exports across Asia, Africa, and the Middle East, committed to improving public health through high-quality research and healthcare initiatives. As the client pursues global expansion, they faced regulatory challenges. To address these, the client engaged Techsol Lifesciences to create a region-specific ASEAN Common Technical Document (ACTD) clinical summary, ensuring compliance with submission requirements for the Brazilian Health Regulatory Agency (ANVISA). 

Project Objective: 

The aim was to prepare a comprehensive clinical summary (Module 2.7) for an epilepsy drug, following ASEAN Common Technical Document (ACTD) guidelines for submission to the Brazilian Health Regulatory Agency (ANVISA), ensuring that the clinical data complied with ACTD guidelines and was adaptable for ANVISA submission.  

Techsol Approach:  

Drafting region-specific clinical summaries for drugs targeting conditions such as epilepsy demands scientific rigor and deep understanding of regulatory requirements and patient perspectives across regions. This involves preparing a compliant, accurate clinical summary that meets ANVISA’s requirements, ensuring successful submission and marketing authorization in Brazil. Techsol’s approach began with a thorough gap analysis of ANVISA’s submission guidelines, focusing on clinical documentation requirements for submission in Brazil. A cross-functional team of medical writers, and regulatory affairs specialists collaborated to ensure the clinical summary accurately reflected clinical trial results while aligning with regulatory expectations. Summarizing Clinical data from Phase I-III trials on efficacy, safety, and statistical significance as per ACTD guidelines. Multiple reviews of the document were done internally to ensure scientific accuracy and regulatory compliance.

Challenges:

Drafting the Clinical Summary (Module 2.7) comes with unique challenges.
Here are some challenges: 

  • Data Harmonization across Regions: ASEAN guidelines for clinical summaries emphasize the importance of summarizing clinical data on efficacy, safety, pharmacokinetics, and pharmacodynamics data from Southeast Asian populations for ANVISA, aligning with Brazil’s regulatory and ICH standards.
  •  Regional Variability in Disease Epidemiology: The prevalence and treatment response of epilepsy and migraine vary by region. Brazil has distinct epidemiological profiles for these conditions, requiring additional data to confirm the relevance of trial outcomes for Brazilian patients.  
  • Gap Analysis: Addressing gaps in the available data and finding alternative ways to mitigate the issues without compromising the integrity of the clinical summary. The client lacked adequate data on the drug’s bioavailability and bioequivalence. 
  • Balancing Conciseness with Completeness: The clinical summary had to be concise enough for regulatory reviewers while providing all necessary clinical data and analysis. Striking the right balance between brevity and detail was challenging. 
  • Complexity of Data Interpretation: The clinical trial data were extensive, involving multiple patient groups and endpoints. Interpreting the data in a way that would be clear to regulatory reviewers, while maintaining scientific accuracy, posed a challenge. 
  • Adherence to ANVISA Guidelines: ANVISA’s guidelines required a high level of detail and specific formatting, which demanded careful attention to the regulatory submission requirements to ensure complaince  

Solutions:

To overcome the challenges in preparing the ACTD document, Techsol’s MW Team adopted a multiple strategies.

  • Data Harmonization across Regions: To address the challenge of harmonizing clinical data across regions, Techsol’s Medical Writing team conducted a thorough literature review of clinical data from Southeast Asian populations, ensuring that efficacy, safety, pharmacokinetics, and pharmacodynamics data were relevant and aligned with ICH standards and Brazil’s regulatory expectations, with close collaboration between regulatory experts from Brazil. 
  • Regional Variability in Disease Epidemiology: A region-specific literature search and real-world evidence from local studies provided up-to-date epidemiological data on epilepsy and migraine in Brazil, supporting the relevance of ASEAN clinical data ensuring that trial outcomes and treatment strategies were applicable to Brazilian patients.
  • Gap Analysis: Techsol Medical Writing brings extensive expertise in utilizing alternative data sources and methodologies to address gaps in data on the drug’s bioavailability and bioequivalence. By employing approaches such as population pharmacokinetic modeling and supplementary studies, Techsol ensures these gaps are effectively mitigated while upholding the integrity of the clinical summary.
  • Balancing Conciseness with Completeness: A rigorous process was followed to ensure that the clinical summary was concise without sacrificing necessary detail. Key data points were prioritized, and a structured approach to the presentation of information was adopted to streamline content while maintaining clarity. This included focusing on high-level summaries of efficacy and safety data, with detailed supporting data included in appendices or supplementary documents. 
  • Complexity of Data Interpretation: Techsol’s in-house clinical data analysts, medical reviewers, biostatisticians, and regulatory experts collaborated closely with medical writers to interpret the extensive trial data accurately and ensure alignment with study objectives. Data were organized into clear visual formats including, tables, graphs, and summary statistics, with, key findings highlighted, and complex analyses were simplified to aid regulatory reviewers in understanding the data’s implications.
  • Adherence to ANVISA Guidelines: A detailed review of ANVISA’s submission guidelines was performed to ensure that clinical summary was in full adherence. Compliance checklists were created, and the submission document underwent multiple rounds of internal reviews to confirm that every aspect of the guidelines was met, including the inclusion of necessary appendices and supplementary documents. 

Project Achievements: 

Techsol’s medical writing team’s expertise and commitment resulted in crafting a high-quality clinical summary within timelines. The document met ANVISA’s regulatory requirements and adhered to the ACTD structure, ensuring a smooth submission process in line with international standards. The clear articulation of patient-centered outcomes, supported by real-world evidence, made the summary relevant to Brazilian clinical practices. ANVISA responded favourably, and the review process proceeded smoothly. 

Project Outcomes:

Techsol’s structured approach resulted in a compliant clinical summary, yielding the following key outcomes:

  • Successful Regulatory Alignment: ANVISA accepted the submission, and the clinical summary was effectively supported the agency’s evaluation of the drug’s efficacy and safety profile, resulting in minimal delays. 
  • Market Expansion and Patient Impact: The drug received marketing authorization in Brazil, enabling the client to commercialize the new treatment for epilepsy and migraine in the Brazilian market. This authorization opened new business opportunities and provided an essential treatment option for epilepsy patients in Brazil. 
how can we help you?

Contact us at the Consulting WP office nearest to you or submit a business inquiry online.

contacts

Send Us Your Requirement

[contact-form-7]

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The post Over coming challenges in drafting region-specific clinical summaries appeared first on Techsol Life Sciences.

]]> Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study https://www.techsollifesciences.com/case-studies/sae-management-review-reporting-during-covid-19-pandemic-for-an-ophthalmology-clinical-study-2/ Thu, 29 Dec 2022 11:50:37 +0000 https://www.techsollifesciences.com/?page_id=7870 During the COVID-19 pandemic, Techsol was in the process of conducting an Ophthalmology related intraocular lens study for the correction of Aphakia. A 49 -year-old Asian Subject earlier diagnosed with Nuclear Sclerosis Grade II Cataract in both eyes, was screened and selected for the study per the inclusion and exclusion criteria. With a medical history of controlled hypertension, the Subject underwent cataract extraction and intraocular lens implantation as part of the ophthalmology study procedure. After the planned post-operative visit, the Subject reported redness, pain and itching on and off in the right eye to the Principal Investigator (PI) through a telephonic call because of the local travel restrictions mandated by the Indian government. To ensure timely data capture and evaluation of the adverse event experience, the site investigator team arranged a video call and evaluated the subject’s safety and confirmed the condition as cystoid macular edema (CME) with reference to the approved clinical study protocol. On the same day, the Site Team also facilitated the Subject’s visit to the site with an ambulance for further medical assessment to complete the event classification and to examine the safety and overall well-being. Challenge Solution Result Challenge The Site Team had to capture the complete adverse event information in a pandemic situation through a video conference. Additionally, the Site Team also had to facilitate the subject’s timely visit to the site for event analysis by following COVID-19 protocols mandated by the government. Ensuring subject’s safety against COVID-19 infection during the site visit was a critical priority during the peak pandemic time. With Techsol’s Clinical Operations team working from home, it was challenging to perform meticulous evaluation of the reported event and classifying it accurately as a Serious Adverse Event (SAE) as per clinical study protocol. Solution The Site Team was trained on the ‘COVID-19 Risk Management Study Guidelines’ that had to be followed for facilitating subject site visits and handling of AEs and SAEs.  Techsol’s Pharmacovigilance and Clinical Affairs team ensured that the Site Team handled the subject visit with all pre-cautionary preventative measures to avoid a COVID-19 infection during the entire visit. Techsol’s team coordinated with the Site team to investigate and accurately capture the SAE’s. The Principal Investigator examined both eyes and diagnosed Cystoid Macular Edema which was severe in the Subject’s right eye.  Techsol’s Medical Expert reviewed and advised the PI to prescribe the appropriate concomitant medication to resolve the SAE. The SAE follow-up visit was scheduled and completed after 14 days from the date of the subject’s site visit. After completing all the follow-up visits, the Investigator prepared the final SAE Report and submitted to Ethics Committee and DCGI Regulatory authority. Result With the COVID-19 experience, CROs, Site Investigators and Sponsors must ensure that the following best practices are implemented as standard processes for SAE handling and reporting: Establish effective site communication channels (telephone, video conference, etc.) to provide timely support to the Subject during an adverse event experience. Based on this case study, it is certain that using the right technology can minimize patient burden and faster resolution. Ensure that the clinical study site and CRO has the right infrastructure and relevant standard processes that must be followed for arranging subject visits during an unprecedented situation. Clinical teams must have ready-to-implement tested safety protocols for facilitating safe and convenient site visits to subjects in the event of a disaster. Medical review plays a significant role in determining causal relationships to avoid misclassification of adverse events and timely reporting of SAEs to health authorities. Company overview Quality Accreditations Meet Our Team Our history Industry Partners Careers how can we help you? Contact us at the Consulting WP office nearest to you or submit a business inquiry online. contacts Send Us Your Requirement Submit

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The post Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study appeared first on Techsol Life Sciences.

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Clinical SAE Case Study

During the COVID-19 pandemic, Techsol was in the process of conducting an Ophthalmology related intraocular lens study for the correction of Aphakia. A 49 -year-old Asian Subject earlier diagnosed with Nuclear Sclerosis Grade II Cataract in both eyes, was screened and selected for the study per the inclusion and exclusion criteria. With a medical history of controlled hypertension, the Subject underwent cataract extraction and intraocular lens implantation as part of the ophthalmology study procedure. After the planned post-operative visit, the Subject reported redness, pain and itching on and off in the right eye to the Principal Investigator (PI) through a telephonic call because of the local travel restrictions mandated by the Indian government.

To ensure timely data capture and evaluation of the adverse event experience, the site investigator team arranged a video call and evaluated the subject’s safety and confirmed the condition as cystoid macular edema (CME) with reference to the approved clinical study protocol. On the same day, the Site Team also facilitated the Subject’s visit to the site with an ambulance for further medical assessment to complete the event classification and to examine the safety and overall well-being.

how can we help you?

Contact us at the Consulting WP office nearest to you or submit a business inquiry online.

contacts

Send Us Your Requirement

[contact-form-7]

The post Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study appeared first on Techsol Life Sciences.

The post Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study appeared first on Techsol Life Sciences.

]]> Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma https://www.techsollifesciences.com/case-studies/oracle-cloud-for-hugel-pharma/ Thu, 29 Dec 2022 09:49:42 +0000 https://www.techsollifesciences.com/?page_id=7817 Hugel Pharma, a global biotechnology firm, had a few approved products that were ready for marketing. The organization, however,did not have a safety system in place. They were looking for a partnerthat could deliver a safety system in a timely manner. Challenge Solution result Challenge Hugel had products that were ready for market and needed a drug safety solution in place. The knowledge of the team with respect to the process for implementing a safety systems was inadequate. They were banking on a partner that could deliver a fully validated system accompanied by project management. The key challenges faced by Hugel were: A limited understanding of safety system implementation Having a fully validated safety system ready in time to market the drugs End-user training for the system was required Solution Techsol and Hugel worked together to deliver a system that met the business requirements through seamless project management. Implementation of Argus Safety v7.0.4.1 on Oracle Cloud was expedited following Oracle’s delivery of the Argus licenses. The entire system was validated by Techsol to ensure compliance with regulatory rules and guidelines. End-user training was provided to ensure the Hugel team was able to work with the new system effectively. Post-implementation ‘hypercare’ (24X7 support) by Techsol made sure that issues were resolved with minimum downtime. result Hugel gained many benefits through the efficient implementation of the drug safety system: A timely delivery of the drug safety system Fully validated system as per GAMP 5 guidelines A 50% reduction in human effort for case processing A system for end-to-end case processing meeting regulatory compliance requirements Compliance audit readiness through the control and recording of all pharmacovigilance and case processing activities Company overview Quality Accreditations Meet Our Team Our history Industry Partners Careers how can we help you? Contact us at the Consulting WP office nearest to you or submit a business inquiry online. contacts Send Us Your Requirement Submit

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Business Meeting

Hugel Pharma, a global biotechnology firm, had a few approved products that were ready for marketing. The organization, however,did not have a safety system in place. They were looking for a partnerthat could deliver a safety system in a timely manner.

how can we help you?

Contact us at the Consulting WP office nearest to you or submit a business inquiry online.

contacts

Send Us Your Requirement

[contact-form-7]

The post Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma appeared first on Techsol Life Sciences.

The post Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma appeared first on Techsol Life Sciences.

]]> Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution https://www.techsollifesciences.com/case-studies/integrated-global-drug-safety-signal-management/ Thu, 29 Dec 2022 09:07:51 +0000 https://www.techsollifesciences.com/?page_id=7807 Ipca is an established Indian pharmaceutical company manufacturing over 350 formulations and 80 active pharmaceutical ingredients for various therapeutic segments. Headquartered in Mumbai, Ipca manufactures and sells branded and generic formulations, APIs and intermediates to 120+ countries. As one of the world’s largest drug manufacturers, they are inspected by US-FDA, UK-MHRA, EDQM- Europe, WHO-Geneva, PMDA and many other regional regulatory bodies. Challenge Solution result Challenge Ipca had performed a rigorous assessment of their current drug safety process, regulatory requirements, system requirements (both current and future scale up) and observed that there were opportunities for improvements across processes, systems and their vendor engagements.Following were some of the key challenges for Ipca: The two safety databases were not integrated, resulting in omissions, redundancies and leading to compliance challenges There were unmet needs such as advanced signal detection/ management and automation of case submission with agencies via gateway Inefficient management of global operations as each region was following a different workflow for case management. Case processing was challenging resulting in missed timelines and increased costs. Reporting, insights and signaling was challenging due to lack of right tools and due to separate databases Solution To fulfill Ipca’s business objectives of optimizing their drug safety operations, Techsol proposed a comprehensive solution with the accomplishment of the following activities: Implement AccelSafety with the Oracle Argus Safety Standard Edition along with Empirica Signal/Topics and Oracle B2B Gateway for Ipca on Techsol’ fully-managed cloud platform Assess and implement configuration best practices including harmonization of P&L (Products & Licenses), submission workflow process, dictionary management, reporting, etc. Complete risk-based validation as per Techsol computer systems validation process and produce audit-ready validation documentation for 21 CFR Part 11 compliance Deliver a hands-on Argus Safety training for Ipca’s business users and application administrators Complete legacy case data migration using Techsol’s proprietary multi-phase, migration methodology to ensure data quality and integrity Conduct pilot testing of electronic submission with regulatory agencies Set-up post-implementation Argus Safety service desk for hypercare and ongoing support result With the successful implementation of Techsol’s AccelSafety, Ipca achieved following business outcomes: Primary objective and goal of having a state-of- the-art, fully integrated data-safety, e- submission and signal detection system was achieved The impact on business was immediate and significant. Efficiency of more than 60% improvement in meeting submission timelines and approximately 50% reduction in case processing times were observed With the utilization of e-Submission Gateway, the ICSR process was automated to provide timely ICSR submissions to FDA and EMA consistent with regulatory standards Now, Ipca could detect signals, uncover patterns, and perform/recognize trends on case data. AccelSafety was ready as a scalable cloud platform to address Ipca’s future growth 24X7 Techsol managed service desk was established to address all post-go-live support activities Company overview Quality Accreditations Meet Our Team Our history Industry Partners Careers how can we help you? Contact us at the Consulting WP office nearest to you or submit a business inquiry online. contacts Send Us Your Requirement Submit

The post Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution appeared first on Techsol Life Sciences.

The post Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution appeared first on Techsol Life Sciences.

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Business Meeting

Ipca is an established Indian pharmaceutical company manufacturing over 350 formulations and 80 active pharmaceutical ingredients for various therapeutic segments. Headquartered in Mumbai, Ipca manufactures and sells branded and generic formulations, APIs and intermediates to 120+ countries. As one of the world’s largest drug manufacturers, they are inspected by US-FDA, UK-MHRA, EDQM- Europe, WHO-Geneva, PMDA and many other regional regulatory bodies.

how can we help you?

Contact us at the Consulting WP office nearest to you or submit a business inquiry online.

contacts

Send Us Your Requirement

[contact-form-7]

The post Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution appeared first on Techsol Life Sciences.

The post Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution appeared first on Techsol Life Sciences.

]]> Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax https://www.techsollifesciences.com/case-studies/gemvax/ Tue, 27 Dec 2022 07:39:11 +0000 https://www.techsollifesciences.com/?page_id=7587 Based out of South Korea, GemVax is one of the leading pharma research and development organization conductiong R & D for anti-cancer iimunotherapeutic and peptide drugs. Challenge Solution Result Challenge GemVax were in need of safety solution as their products are ready to be marketed. They had a limited understanding of the overall process of implementing a safety systems application. The requirement was to manage the entire project to deliver a fully validated system before marketing of the approved products. The key challenges GemVax faced in preparing to marl‹et their approved products: Limited understanding of safety system implementation Implementing a fully validated safety system in time to market the drugs End-user training to work on the newly implemented system Solution Techsol worked with GemVax to manage the project and ensure delivery of all elements required to meet the business objectives. Post-delivery by Oracle, we fast-tracked implementation of Argus Safety v7.0.4.1 on Oracle cloud. Our team provided validation for the entire system to mal‹e sure the application was compliant with the regulatory rules/guidelines. We provided end-user training to ensure the application was used to its full potential, accurately. We provided post-implementation hypercare to GemVaH team ensuring dll their issues were resolved in a timely manner. Result Efficient execution of the project brought many favourable results for the client: The safety system was ready before the product go-live and on-going study Fully validated system as per GAMP5 guidelines Reduction in human effort for case processing Regulatory compliant system with the ability to perform end-to-end case processing Increased audit compliance with more control over all pharmacovigilance activities and recording of all case processing activities Company overview Quality Accreditations Meet Our Team Our history Industry Partners Careers how can we help you? Contact us at the Consulting WP office nearest to you or submit a business inquiry online. contacts Send Us Your Requirement Submit

The post Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax appeared first on Techsol Life Sciences.

The post Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax appeared first on Techsol Life Sciences.

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Business Meeting

Based out of South Korea, GemVax is one of the leading pharma research and development organization conductiong R & D for anti-cancer iimunotherapeutic and peptide drugs.

how can we help you?

Contact us at the Consulting WP office nearest to you or submit a business inquiry online.

contacts

Send Us Your Requirement

[contact-form-7]

The post Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax appeared first on Techsol Life Sciences.

The post Argus Safety Cloud Implementation on Oracle Cloud for KAEL-GemVax appeared first on Techsol Life Sciences.

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