Innovation Archives - Techsol Life Sciences https://www.techsollifesciences.com/casestudy_category/innovation/ Navigate To Excellence Mon, 15 Sep 2025 09:23:24 +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 Innovation Archives - Techsol Life Sciences https://www.techsollifesciences.com/casestudy_category/innovation/ 32 32 Case Study on Meta-Analysis of Curcuma longa https://www.techsollifesciences.com/case-studies/case-study-on-meta-analysis-of-curcuma-longa/ Tue, 10 Jun 2025 07:43:39 +0000 https://www.techsollifesciences.com/?page_id=21788 Case Study on Meta-Analysis of Curcuma longa Geography: N/A Type Service: N/A Background/Client Requirement: Our client is a prominent pharmaceutical company renowned for its innovation in drug delivery systems and formulation development, focuses on enhancing therapeutic outcomes through advanced, technology-driven pharmaceutical products. The client specializes in the research, development, and commercialization of diverse healthcare solutions, particularly in novel drug delivery technologies. Its portfolio includes oral, injectable, and transdermal solutions designed to enhance patient compliance and provide more effective treatment options. The client has outsourced Techsol Lifesciences to conduct a meta-analysis on the safety and efficacy of turmeric (Curcuma longa) extract and curcumin supplements for musculoskeletal health. Project Objectives:  The objective was to perform a systematic review and meta-analysis to evaluate the effective dose, safety, and efficacy of turmeric extract and curcumin supplements in promoting musculoskeletal health. This meta-analysis presents a comprehensive assessment of results and compares the effective doses of curcumin supplements for their impact on musculoskeletal health. Challenges:    Conducting a meta-analysis presents several challenges, many of which stem from variations and limitations in the primary studies being analyzed.  Key challenges include: Data Availability and Quality: Accessing high-quality, consistent data across studies can be challenging. Some studies may lack comprehensive data, use varying measurement techniques, or provide incomplete reporting. Study Heterogeneity: Differences in study design, participant characteristics, and interventions can lead to heterogeneity, complicating pooled analysis Publication Bias: Positive results are more likely to be published, leading to potential bias that can skew the meta-analysis. Time-Consuming Process: The process requires extensive literature searches, meticulous data extraction, and rigorous quality assessment, making it labor-intensive and time-consuming. Effect size: Inconsistent reporting of effect sizes hinder accurate comparisons across studies and estimation of an overall effect size. Multiple outcome: Including multiple outcomes from the same study risks over-representation, while excluding the risks may result in omitting valuable insights. Variability: High variability in study outcomes can pose challenges in assessing the reliability or generalizability of the findings. Techsol Solution/Approach: Our approach starts with strict implementation of inclusion criteria to ensure that only high-quality studies are included. Collaborate with study authors or utilize databases that ensure high reporting standards. Consider using imputation methods to address missing data points when necessary. Conducting subgroup analyses or meta-regression to account for variability across studies. Alternatively, a random-effects model can help accommodate heterogeneity, though this should be used with caution. Use statistical tools like funnel plots or Egger’s test to detect publication bias. Including unpublished studies or registered clinical trials can also help minimize this bias. Train team members on best practices for systematic literature review and data extraction. Consider assigning specialized roles (e.g., one team for data extraction, another for quality assessment) to build expertise and further streamline each phase. Applying multivariate meta-analysis techniques in R and NCSS for reporting multiple outcomes. These methods account for correlations among outcomes while selecting a primary outcome to avoid redundancy and over-representation of individual studies.  Interpret results with caution, particularly in the presence of high variability or potential biases. Employing NCSS and R tools to visualize data distributions and highlight variability. This ensures transparent reporting of study limitations and informs recommendations for future research. Project Achievements:   Our robust approach to data collection, quality control, and analysis, this project achieved a high-quality meta-analysis on the safety and efficacy of turmeric (Curcuma longa) extract and curcumin supplements for musculoskeletal health.  Key achievements included: High-Quality Data Selection: Strict inclusion criteria and collaboration ensured selection of high-quality studies. This improved data reliability and validity in the final analysis. Effective Management of Study Heterogeneity: By applying subgroup analyses and a random-effects models, the approach effectively addressed variations across studies, leading to more nuanced understanding of turmeric’s effects on diverse patient groups. Minimized Publication Bias: Utilization of funnel plots, Egger’s test, and inclusion of unpublished studies helped detect and reduce publication bias, ensuring a balanced and accurate meta-analysis. Advanced Outcome Analysis: Adoption of multivariate meta-analysis techniques in R and NCSS enabled handling of correlated outcomes, preventing redundancy and ensuring a holistic representation of study findings. Clear and Comprehensive Interpretation: Sensitivity analyses and data visualization visualization using NCSS and R tools facilitated transparent interpretation of variability and limitations, empowering stakeholders with actionable insights. These achievements highlighted Techsol’s commitment to delivering reliable, efficient, and actionable meta-analyses, advancing the rigor and credibility of research synthesis processes, enabling more robust and actionable insights into turmeric and curcumin supplements for musculoskeletal health.  The Outcome: The meta-analysis results indicate that turmeric extract and curcumin supplements can serve as effective adjuvants for the management of musculoskeletal health, with a low incidence of adverse events.  The studies included utilized diverse doses and treatment durations. Statistical evaluation revealed that water-dispersible turmeric extract at a low dose of 250 mg/day was found to be more effective than other curcumin products.  Further evaluation through future clinical trials is necessary to establish the appropriate effective dose of curcumin supplements for the overall maintenance of musculoskeletal health. 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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Case Study on Meta-Analysis of Curcuma longa

🌍 Geography: N/A
💊 Type Service: N/A

Background/Client Requirement:

Our client is a prominent pharmaceutical company renowned for its innovation in drug delivery systems and formulation development, focuses on enhancing therapeutic outcomes through advanced, technology-driven pharmaceutical products. The client specializes in the research, development, and commercialization of diverse healthcare solutions, particularly in novel drug delivery technologies. Its portfolio includes oral, injectable, and transdermal solutions designed to enhance patient compliance and provide more effective treatment options. The client has outsourced Techsol Lifesciences to conduct a meta-analysis on the safety and efficacy of turmeric (Curcuma longa) extract and curcumin supplements for musculoskeletal health.

Project Objectives: 

The objective was to perform a systematic review and meta-analysis to evaluate the effective dose, safety, and efficacy of turmeric extract and curcumin supplements in promoting musculoskeletal health. This meta-analysis presents a comprehensive assessment of results and compares the effective doses of curcumin supplements for their impact on musculoskeletal health.

    Challenges:  
     Conducting a meta-analysis presents several challenges, many of which stem from variations and limitations in the primary studies being analyzed. 

    Key challenges include:
    • Data Availability and Quality: Accessing high-quality, consistent data across studies can be challenging. Some studies may lack comprehensive data, use varying measurement techniques, or provide incomplete reporting.
    • Study Heterogeneity: Differences in study design, participant characteristics, and interventions can lead to heterogeneity, complicating pooled analysis
    • Publication Bias: Positive results are more likely to be published, leading to potential bias that can skew the meta-analysis.
    • Time-Consuming Process: The process requires extensive literature searches, meticulous data extraction, and rigorous quality assessment, making it labor-intensive and time-consuming.
    • Effect size: Inconsistent reporting of effect sizes hinder accurate comparisons across studies and estimation of an overall effect size.
    • Multiple outcome: Including multiple outcomes from the same study risks over-representation, while excluding the risks may result in omitting valuable insights.
    • Variability: High variability in study outcomes can pose challenges in assessing the reliability or generalizability of the findings.
Techsol Solution/Approach:
  • Our approach starts with strict implementation of inclusion criteria to ensure that only high-quality studies are included. Collaborate with study authors or utilize databases that ensure high reporting standards. Consider using imputation methods to address missing data points when necessary.
  • Conducting subgroup analyses or meta-regression to account for variability across studies. Alternatively, a random-effects model can help accommodate heterogeneity, though this should be used with caution.
  • Use statistical tools like funnel plots or Egger’s test to detect publication bias. Including unpublished studies or registered clinical trials can also help minimize this bias.
  • Train team members on best practices for systematic literature review and data extraction. Consider assigning specialized roles (e.g., one team for data extraction, another for quality assessment) to build expertise and further streamline each phase.
  • Applying multivariate meta-analysis techniques in R and NCSS for reporting multiple outcomes. These methods account for correlations among outcomes while selecting a primary outcome to avoid redundancy and over-representation of individual studies. 
  • Interpret results with caution, particularly in the presence of high variability or potential biases. Employing NCSS and R tools to visualize data distributions and highlight variability. This ensures transparent reporting of study limitations and informs recommendations for future research.

Project Achievements:  

Our robust approach to data collection, quality control, and analysis, this project achieved a high-quality meta-analysis on the safety and efficacy of turmeric (Curcuma longa) extract and curcumin supplements for musculoskeletal health. 

Key achievements included:

  • High-Quality Data Selection: Strict inclusion criteria and collaboration ensured selection of high-quality studies. This improved data reliability and validity in the final analysis.
  • Effective Management of Study Heterogeneity: By applying subgroup analyses and a random-effects models, the approach effectively addressed variations across studies, leading to more nuanced understanding of turmeric’s effects on diverse patient groups.
  • Minimized Publication Bias: Utilization of funnel plots, Egger’s test, and inclusion of unpublished studies helped detect and reduce publication bias, ensuring a balanced and accurate meta-analysis.
  • Advanced Outcome Analysis: Adoption of multivariate meta-analysis techniques in R and NCSS enabled handling of correlated outcomes, preventing redundancy and ensuring a holistic representation of study findings.
  • Clear and Comprehensive Interpretation: Sensitivity analyses and data visualization visualization using NCSS and R tools facilitated transparent interpretation of variability and limitations, empowering stakeholders with actionable insights.
These achievements highlighted Techsol’s commitment to delivering reliable, efficient, and actionable meta-analyses, advancing the rigor and credibility of research synthesis processes, enabling more robust and actionable insights into turmeric and curcumin supplements for musculoskeletal health. 
The Outcome:
  • The meta-analysis results indicate that turmeric extract and curcumin supplements can serve as effective adjuvants for the management of musculoskeletal health, with a low incidence of adverse events. 
  • The studies included utilized diverse doses and treatment durations. Statistical evaluation revealed that water-dispersible turmeric extract at a low dose of 250 mg/day was found to be more effective than other curcumin products. 
  • Further evaluation through future clinical trials is necessary to establish the appropriate effective dose of curcumin supplements for the overall maintenance of musculoskeletal health.

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]

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]]> Case Study on State of the Art (SoTA) for Refractive Surgery & Keratoplasty https://www.techsollifesciences.com/case-studies/case-study-on-state-of-the-art-for-refractive-surgery-keratoplasty/ Tue, 27 May 2025 08:18:28 +0000 https://www.techsollifesciences.com/?page_id=21717 Case Study on State of the Art (SoTA) for Refractive Surgery & Keratoplasty Geography: Global Type Service: Medical Writing Sponsor: The manufacturer, a leading provider of ophthalmic surgical instruments, faced the challenge of consolidating multiple reusable instruments and devices under one state-of-the-art report to meet the stringent requirements set by the EU MDR 2017/745 regulations. Facing a shortage of available data, the manufacturer sought a comprehensive solution to tackle the challenge and ensure compliance. Techsol Approach:   Holistic Data Collection and Analysis: The team implemented a robust data collection system to gather detailed information on each reusable instrument and device. This involved collaborating with various departments to ensure all relevant data was captured. Comprehensive Reporting: Extensive data analysis has been collected, systematically analyzed, and consolidated into a single cohesive report designed to meet the high standards of accuracy and detail required by the EU MDR regulations. Regulatory Alignment: Working closely with regulatory experts ensured that the report meets all specific standards and guidelines, with regular reviews and updates conducted to align the report with evolving regulatory requirements. Challenges:   The Challenges was twofold Data Consolidation: Covering a wide range of reusable instruments and devices in one comprehensive report. This required a holistic approach to gather, analyze, and present all necessary information accurately. Regulatory Compliance: Complying with the EU MDR 2017/745 regulations added another layer of complexity. The state-of-the-art report needed to adhere to specific standards and guidelines set by regulatory authorities, ensuring that all data was presented in a compliant manner. Solutions:   Techsol’s expertise team generated a State-of-the-Art report and carefully documented the state-of-the-art technologies and advancements in refractive surgery. Our team meticulously reviewed the instruments/devices, and came up with a comprehensive solution, addressed data shortage, and ensured full compliance with EU MDR 2017/745 regulations. Our comprehensive analysis encompassed areas such as efficiency, safety, effectiveness, and usability, providing Manufacturer with a detailed overview of the current landscape. Benefits with Techsol: Partnering with us ensured regulatory compliance, streamlined documentation, facilitated comprehensive analysis with advanced technologies, and gained confidence in our analysis. Project Outcomes:   Our collaboration resulted in a successful outcome, highlighting the importance of thorough data analysis and adherence to regulatory standards in the medical device industry. Manufacturer was able to demonstrate their commitment to excellence and compliance. We take pride in supporting the Manufacturer on their path to delivering innovative and dependable solutions for ophthalmic surgery. If you would like to learn more about our services or discuss how we can assist your business, please feel free to reach out to us at info@techsollifesciences.com.  We look forward to helping you achieve your goals.  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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Case Study on State of the Art (SoTA) for Refractive Surgery & Keratoplasty

Geography: Global
Type Service: Medical Writing

Sponsor:

The manufacturer, a leading provider of ophthalmic surgical instruments, faced the challenge of consolidating multiple reusable instruments and devices under one state-of-the-art report to meet the stringent requirements set by the EU MDR 2017/745 regulations. Facing a shortage of available data, the manufacturer sought a comprehensive solution to tackle the challenge and ensure compliance.

Techsol Approach:  

  • Holistic Data Collection and Analysis: The team implemented a robust data collection system to gather detailed information on each reusable instrument and device. This involved collaborating with various departments to ensure all relevant data was captured.
  • Comprehensive Reporting: Extensive data analysis has been collected, systematically analyzed, and consolidated into a single cohesive report designed to meet the high standards of accuracy and detail required by the EU MDR regulations.
  • Regulatory Alignment: Working closely with regulatory experts ensured that the report meets all specific standards and guidelines, with regular reviews and updates conducted to align the report with evolving regulatory requirements.

Challenges:  

The Challenges was twofold

  • Data Consolidation: Covering a wide range of reusable instruments and devices in one comprehensive report. This required a holistic approach to gather, analyze, and present all necessary information accurately.
  • Regulatory Compliance: Complying with the EU MDR 2017/745 regulations added another layer of complexity. The state-of-the-art report needed to adhere to specific standards and guidelines set by regulatory authorities, ensuring that all data was presented in a compliant manner.
Solutions:  
  • Techsol’s expertise team generated a State-of-the-Art report and carefully documented the state-of-the-art technologies and advancements in refractive surgery.
  • Our team meticulously reviewed the instruments/devices, and came up with a comprehensive solution, addressed data shortage, and ensured full compliance with EU MDR 2017/745 regulations.
  • Our comprehensive analysis encompassed areas such as efficiency, safety, effectiveness, and usability, providing Manufacturer with a detailed overview of the current landscape.
  • Benefits with Techsol: Partnering with us ensured regulatory compliance, streamlined documentation, facilitated comprehensive analysis with advanced technologies, and gained confidence in our analysis.

Project Outcomes:  

Our collaboration resulted in a successful outcome, highlighting the importance of thorough data analysis and adherence to regulatory standards in the medical device industry. Manufacturer was able to demonstrate their commitment to excellence and compliance. We take pride in supporting the Manufacturer on their path to delivering innovative and dependable solutions for ophthalmic surgery.
If you would like to learn more about our services or discuss how we can assist your business, please feel free to reach out to us at info@techsollifesciences.com. 
We look forward to helping you achieve your goals. 

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 Case Study on State of the Art (SoTA) for Refractive Surgery & Keratoplasty appeared first on Techsol Life Sciences.

The post Case Study on State of the Art (SoTA) for Refractive Surgery & Keratoplasty appeared first on Techsol Life Sciences.

]]> Achieving Milestones for a Systematic Review & Meta-analysis Manuscript https://www.techsollifesciences.com/case-studies/achieving-milestones-for-a-systematic-review-meta-analysis-manuscript/ Wed, 30 Apr 2025 09:22:56 +0000 https://www.techsollifesciences.com/?page_id=21510 Achievement in the Preparation of manuscript for a Systematic Review and Meta-Analysis Geography: Global Type Service: Authoring Manuscript Overview: In the highly competitive pharmaceutical industry landscape, sharing of research findings through scientific manuscripts is vital for advancing medical knowledge and promoting therapeutic innovations. Techsol, is a leading service provider of specialized scientific solutions, and plays a crucial role in supporting pharmaceutical companies with crafting high quality manuscripts. This case study highlights how Techsol expertise in manuscript development ensures the production of exceptional publications, enhancing the reputation and credibility of the client. Background/Client Requirement: Drafting a systematic review and meta-analysis manuscript is a rigorous task that requires detailed planning, thorough literature research and clear, structured writing. The sponsor, primarily a pharmaceutical manufacturing company, approached Techsol life sciences to craft a systematic review and meta-analysis manuscript, leveraging Techsol’s expertise in medical writing services. Project Aim:  The aim of the project was to support the sponsor in preparing a systematic review and meta-analysis manuscript that adhered to industry standards.Techsol Approach:    Techsol’s approach to this project involved: In-depth Planning: We began by understanding the sponsor’s objectives and key areas of interest for the systematic review and meta-analysis. Comprehensive Literature Search: Utilizing advanced databases and resources, we conducted an exhaustive search for relevant studies, ensuring the inclusion of high-quality research articles. Data Extraction & Analysis: The team meticulously extracted and analyzed data, ensuring that statistical methods were aligned with the latest guidelines and best practices in meta-analysis. Structured Writing: With clear and concise writing, we ensured that the manuscript adhered to established guidelines, including PRISMA, for systematic reviews and meta-analyses. Review & Refinement: Multiple rounds of internal and client reviews ensures highest quality standards. Challenges:   Challenges encountered throughout the manuscript drafting include: Data Inconsistencies: One primary hurdle involved was the exhaustive task of scouring extensive databases to identify pertinent studies, necessitating careful search strategies aligned with specific inclusion criteria.  Complex Statistical Methods: The meta-analysis demanded the application of advanced statistical techniques to synthesize results across multiple studies. This complexity introduced challenges in maintaining both accuracy and clarity in the analysis, requiring meticulous attention to detail. Time Constraints: A pressing deadline further compounded the difficulties, creating pressure to complete the project within a short timeframe.  A pressing deadline further compounded the difficulties, creating pressure to complete the project within a short timeframe.  Ethical Concerns: Moreover, dealing with ethical concerns such as plagiarism and data falsification posed formidable obstacles, as these actions could compromise the manuscript’s integrity and erode trust in the research findings.  To address these challenges, Techsol’s expertise in medical writing, data management, statistical analysis, and project coordination played a crucial role in delivering a high-quality, publication-ready document within the stipulated timeframe and with accurate output for the sponsor. Solutions:   Effective Approach: A comprehensive strategy ensured clarity, thoroughness, and compliance with standard guidelines such as PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis). AI-Driven Tool: Our exclusive AI-driven literature screening tool “COMPIER” played a vital role in extracting the accurate articles. Literature Search: Our team conducted a thorough literature search using advanced search techniques and multiple databases (PubMed, Google Scholar, and Cochrane Library).  Manual Bibliography Checks: Our Medical writers even manually checked the bibliographies of the identified articles, including relevant systematic reviews and meta-analyses, to identify additional eligible studies. Meticulous Project Planning: Planned the project timeline meticulously, set realistic deadlines, and prioritized tasks effectively. Expert Statistical Support: The team incorporated advanced statistical tools and worked closely with biostatisticians to ensure that complex analyses were carried out correctly and presented clearly. Streamlined Project Management: Techsol leveraged its streamlined project management processes, working in parallel on different sections of the manuscript to meet the deadline without compromising quality. Regular Progress Meetings: Regular progress meetings helped to keep the project on track and we also used plagiarism detection software. Multi-Layered Review Process: Performed a multi-layered review process (Peer review, Senior Medical writer review, QC review) to uphold scientific standards, which is crucial for publishing. Project Achievements: Timely Completion: Successfully drafted and delivered the manuscript within the stipulated timeline, meeting the sponsor’s urgent deadline. High-Quality Manuscript: Delivered a well-structured, scientifically sound manuscript, adhering to PRISMA guidelines and ensuring it was ready for submission to high-impact journals The Outcome:The extensive systematic reviews and meta-analyses carried out by the medical writers had a notable influence. Successful Manuscript Submission: The manuscript was successfully submitted to a high-impact journal, significantly enhancing the sponsor’s visibility in the scientific community. Enhanced Client Reputation: The project contributed to the sponsor’s reputation as a leader in the pharmaceutical industry, particularly in the field of systematic reviews and meta-analyses. Client Satisfaction: The sponsor expressed high satisfaction with Techsol’s medical writing ability to meet deadlines, maintain scientific rigor, and delivering a high-quality manuscript that addressed all of their requirements.  Call to Action Are you looking to enhance your pharmaceutical research publication efforts?Contact Techsol to discuss how we can support your projects with expert scientific and medical writing services. 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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Achievement in the Preparation of manuscript for a Systematic Review and Meta-Analysis

🌍 Geography: Global
💊 Type Service: Authoring Manuscript

Overview:

In the highly competitive pharmaceutical industry landscape, sharing of research findings through scientific manuscripts is vital for advancing medical knowledge and promoting therapeutic innovations. Techsol, is a leading service provider of specialized scientific solutions, and plays a crucial role in supporting pharmaceutical companies with crafting high quality manuscripts. This case study highlights how Techsol expertise in manuscript development ensures the production of exceptional publications, enhancing the reputation and credibility of the client.

Background/Client Requirement:

Drafting a systematic review and meta-analysis manuscript is a rigorous task that requires detailed planning, thorough literature research and clear, structured writing. The sponsor, primarily a pharmaceutical manufacturing company, approached Techsol life sciences to craft a systematic review and meta-analysis manuscript, leveraging Techsol’s expertise in medical writing services.

Project Aim: 

The aim of the project was to support the sponsor in preparing a systematic review and meta-analysis manuscript that adhered to industry standards.
Techsol Approach:   

Techsol’s approach to this project involved:

  • In-depth Planning: We began by understanding the sponsor’s objectives and key areas of interest for the systematic review and meta-analysis.
  • Comprehensive Literature Search: Utilizing advanced databases and resources, we conducted an exhaustive search for relevant studies, ensuring the inclusion of high-quality research articles.
  • Data Extraction & Analysis: The team meticulously extracted and analyzed data, ensuring that statistical methods were aligned with the latest guidelines and best practices in meta-analysis.
  • Structured Writing: With clear and concise writing, we ensured that the manuscript adhered to established guidelines, including PRISMA, for systematic reviews and meta-analyses.
  • Review & Refinement: Multiple rounds of internal and client reviews ensures highest quality standards.

Challenges:  

Challenges encountered throughout the manuscript drafting include:

  • Data Inconsistencies: One primary hurdle involved was the exhaustive task of scouring extensive databases to identify pertinent studies, necessitating careful search strategies aligned with specific inclusion criteria. 
  • Complex Statistical Methods: The meta-analysis demanded the application of advanced statistical techniques to synthesize results across multiple studies. This complexity introduced challenges in maintaining both accuracy and clarity in the analysis, requiring meticulous attention to detail.
  • Time Constraints: A pressing deadline further compounded the difficulties, creating pressure to complete the project within a short timeframe.  A pressing deadline further compounded the difficulties, creating pressure to complete the project within a short timeframe. 
  • Ethical Concerns: Moreover, dealing with ethical concerns such as plagiarism and data falsification posed formidable obstacles, as these actions could compromise the manuscript’s integrity and erode trust in the research findings. 

To address these challenges, Techsol’s expertise in medical writing, data management, statistical analysis, and project coordination played a crucial role in delivering a high-quality, publication-ready document within the stipulated timeframe and with accurate output for the sponsor.

Solutions:  
  • Effective Approach: A comprehensive strategy ensured clarity, thoroughness, and compliance with standard guidelines such as PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis).
  • AI-Driven Tool: Our exclusive AI-driven literature screening tool “COMPIER” played a vital role in extracting the accurate articles.
  • Literature Search: Our team conducted a thorough literature search using advanced search techniques and multiple databases (PubMed, Google Scholar, and Cochrane Library). 
  • Manual Bibliography Checks: Our Medical writers even manually checked the bibliographies of the identified articles, including relevant systematic reviews and meta-analyses, to identify additional eligible studies.
  • Meticulous Project Planning: Planned the project timeline meticulously, set realistic deadlines, and prioritized tasks effectively.
  • Expert Statistical Support: The team incorporated advanced statistical tools and worked closely with biostatisticians to ensure that complex analyses were carried out correctly and presented clearly.
  • Streamlined Project Management: Techsol leveraged its streamlined project management processes, working in parallel on different sections of the manuscript to meet the deadline without compromising quality.
  • Regular Progress Meetings: Regular progress meetings helped to keep the project on track and we also used plagiarism detection software.
  • Multi-Layered Review Process: Performed a multi-layered review process (Peer review, Senior Medical writer review, QC review) to uphold scientific standards, which is crucial for publishing.

Project Achievements:

  • Timely Completion: Successfully drafted and delivered the manuscript within the stipulated timeline, meeting the sponsor’s urgent deadline.
  • High-Quality Manuscript: Delivered a well-structured, scientifically sound manuscript, adhering to PRISMA guidelines and ensuring it was ready for submission to high-impact journals
The Outcome:
The extensive systematic reviews and meta-analyses carried out by the medical writers had a notable influence.
  • Successful Manuscript Submission: The manuscript was successfully submitted to a high-impact journal, significantly enhancing the sponsor’s visibility in the scientific community.
  • Enhanced Client Reputation: The project contributed to the sponsor’s reputation as a leader in the pharmaceutical industry, particularly in the field of systematic reviews and meta-analyses.
  • Client Satisfaction: The sponsor expressed high satisfaction with Techsol’s medical writing ability to meet deadlines, maintain scientific rigor, and delivering a high-quality manuscript that addressed all of their requirements.
 Call to Action

Are you looking to enhance your pharmaceutical research publication efforts?
Contact Techsol to discuss how we can support your projects with expert scientific and medical writing services.

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 Achieving Milestones for a Systematic Review & Meta-analysis Manuscript appeared first on Techsol Life Sciences.

The post Achieving Milestones for a Systematic Review & Meta-analysis Manuscript appeared first on Techsol Life Sciences.

]]> Implementation and Validation of a Cloud-based Clinical Data Management System for a Leading Pharmaceutical Company https://www.techsollifesciences.com/case-studies/implementation-and-validation-of-a-cloud-based-clinical-data-management-system-for-a-leading-pharmaceutical-company/ Wed, 24 Jan 2024 11:23:14 +0000 https://www.techsollifesciences.com/?page_id=20159 About Client: Our client, a top 5 Indian pharmaceutical company headquartered in Hyderabad, India, specializes in the development, manufacturing, and distribution of various generic formulations, active pharmaceutical ingredients (APIs), biosimilars and proprietary products. The company’s generic products are indicated for the treatment of gastrointestinal disorders, various cancer types, pain, cardiovascular diseases, central nervous system disorders, infectious diseases, and pediatric diseases. Operating in over 100 countries, they are committed to improving global healthcare access, promoting innovation, and enhancing patient well-being. 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 Challenge Solution Result Challenge The client previously outsourced their clinical operations and clinical data management to Contract Research Organizations. The company decided to bring these critical clinical development processes in-house. As part of this strategic shift, they procured Oracle’s Clinical One System for executing the end-to-end clinical data management processes in-house using their team members. The client had the following challenges to successfully complete the implementation and validation of this new system: Limitation on Application Knowledge: To implement and validate Oracle’s Clinical One application, the client did not have a talent pool who had both application knowledge and business process expertise for timely completing the rollout of this new system to support their clinical data management operations. Lack of Configuration & Validation SMEs: Due to a shortage of trained Subject Matter Experts (SMEs), the client faced difficulty in configuring the Clinical One application to suit their business process needs before validating it for regulatory compliance. New Process Documentation: Although they had quality policies and procedures in place, there was a pressing need to develop new Standard Operating Procedures (SOPs), Policies and Procedures (POLs), and work instructions for effectively using the Clinical One application. Solution Techsol responded to the client’s needs by providing Oracle certified Clinical One specialized consultants, who had expertise in both computer systems validation and clinical data management domain knowledge. Key aspects of the project included: System Requirements Gathering: Techsol’s team worked closely with the client’s personnel to collect system requirements for implementing the next-generation Electronic Data Capture (EDC) application. To meet the urgent business requirements, three full-time equivalent (FTE) resources from Techsol collaborated with the client’s team.  Installation Qualification: Oracle completed the installation qualification of the Clinical One application for the client, as it was a cloud-based solution. Our team ensured that all the key validation documents provided by Oracle were verified and accounted for regulatory compliance. Configuration & Validation: Techsol undertook the essential tasks of configuring and validating the Clinical One application in adherence to the client’s validation standard operating procedures. All validation documentation was authored, executed, reviewed, and approved by adhering to the industry recommended GAMP 5 validation methodology. Process Gap Analysis & New SOP Development: A comprehensive gap analysis was performed to ensure that system configurations were in alignment with the newly developed SOPs and work instructions. Given the absence of readily available SOPs, Techsol team drafted the necessary SOPs aligned with industry best practices for executing the client’s clinical data management process using the Clinical One application.  Training and User Acceptance Testing: Techsol’s SMEs delivered hands-on application training to the client’s team, enabling them to execute Performance Qualification/User Acceptance Testing (PQ/UAT). Result The collaboration between Techsol and the client resulted in significant achievements: Effective Coordination: Techsol established seamless coordination with client’s Clinical Operations, Digital and Process Excellence (DPEX), Quality Assurance (QA), and Validation departments. This collaboration streamlined the project, ensuring that every department’s requirements were met. Zero Execution & Process Errors: The project was executed without any errors, ensuring a smooth implementation of the Clinical One application. Techsol’s team of consultants had hands-on experience on both the Clinical One application and the Clinical Data Management process which eliminated process errors and validation execution errors. IQ Documentation: Installation Qualification (IQ) documentation was provided by Oracle, given the nature of the application which was delivered using the Software as a Service (SaaS) model. OQ Documentation: Our team had leveraged our validation accelerator package which had readily defined Operational Qualification (OQ) test scripts for the Clinical One application. This resulted in a 40% time reduction for the client, helping them to achieve their planned timeline for system rollout. PQ/UAT Scripting & Execution: With our certified Clinical One Consultants, we authored the PQ/UAT scripts that were aligned to the newly drafted SOPs, enabling the client to seamlessly execute the User Acceptance Testing. Our team was readily available to support users for completing the UAT execution. Cost Reduction: With a remote project engagement model and readily available validation accelerators, the client experienced an impressive 45% reduction in the overall Clinical One implementation and validation costs. By transitioning to in-house capabilities and optimizing their systems, the client achieved substantial cost savings. Regulatory Compliance: Techsol followed the GAMP 5 Risk-based validation approach, ensuring that the client achieved 100% compliance with FDA’s 21 Part 11 and EU Annex 11 regulatory requirements. This provided accountability on the data integrity of all electronic records and validity of executed electronic signatures that were correctly reflected in the audit trail. Conclusion: Techsol’s validation expertise and collaborative team effort resulted in the successful implementation of Oracle’s Clinical One application for the client empowering them to establish their in-house clinical data management operations. The collaborative development of new SOPs and work instructions for using the Clinical One application was a key learning for Techsol as it involved multiple discussions with various stakeholders from the client side. With this success, the client has now entrusted us to provide application support after Go-Live to ensure business continuity. Client Testimonial “Our decision to bring in-sourcing was driven by the desire for greater control, efficiency, and the ability to tailor our processes to meet the specific needs of our clinical trial programs. This milestone is the culmination of months of meticulous planning, hard work, and collaboration across teams. We would like to give a special shout out

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Implementation and Validation of a Cloud-based Clinical Data Management System

About Client:

Our client, a top 5 Indian pharmaceutical company headquartered in Hyderabad, India, specializes in the development, manufacturing, and distribution of various generic formulations, active pharmaceutical ingredients (APIs), biosimilars and proprietary products. The company’s generic products are indicated for the treatment of gastrointestinal disorders, various cancer types, pain, cardiovascular diseases, central nervous system disorders, infectious diseases, and pediatric diseases.

Operating in over 100 countries, they are committed to improving global healthcare access, promoting innovation, and enhancing patient well-being.

how can we help you?

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

contacts

Conclusion:

Techsol’s validation expertise and collaborative team effort resulted in the successful implementation of Oracle’s Clinical One application for the client empowering them to establish their in-house clinical data management operations. The collaborative development of new SOPs and work instructions for using the Clinical One application was a key learning for Techsol as it involved multiple discussions with various stakeholders from the client side. With this success, the client has now entrusted us to provide application support after Go-Live to ensure business continuity.

Client Testimonial

“Our decision to bring in-sourcing was driven by the desire for greater control, efficiency, and the ability to tailor our processes to meet the specific needs of our clinical trial programs. This milestone is the culmination of months of meticulous planning, hard work, and collaboration across teams. We would like to give a special shout out to Techsol team members for their exceptional contributions, hard work, and support in timely completing the Clinical One systems validation and CDM process development.

The successful go-live of Clinical one sets a high standard for the continued phases of this initiative and have full confidence that our dedication and collaborative spirit will carry us forward to accomplish our business goals around clinical data management.”

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The post Implementation and Validation of a Cloud-based Clinical Data Management System for a Leading Pharmaceutical Company appeared first on Techsol Life Sciences.

The post Implementation and Validation of a Cloud-based Clinical Data Management System for a Leading Pharmaceutical Company appeared first on Techsol Life Sciences.

]]> Enhancing Clinical Trial Performance with an Innovative Clinical Trial Management System Accelerator https://www.techsollifesciences.com/case-studies/enhancing-clinical-trial-performance-with-an-innovative-clinical-trial-management-system-accelerator/ Thu, 29 Dec 2022 10:40:03 +0000 https://www.techsollifesciences.com/?page_id=7861 Our client is a global pharmaceutical company with revenues of $ 4 billion and is the fifth largest specialty generic pharmaceutical company in the world, providing high-quality affordable medicines in over 150 countries. In the US market, which contributes a significant share of revenues, they are a leader in the generic dermatology and complex product segments. Challenge Solution Result Challenge Siebel is a state-of-the art system that meets all industry standards and regulatory requirements. However, Techsol determined that there were ways to enhance and accelerate the functionality of Siebel and developed AccelCTMS. After a complete study by the combined Client/Techsol team, including meetings with the organization’s key personnel for discussion and analysis, the Techsol staff identified critical issues for immediate action: Tools were needed to facilitate clinical trial planning with better budget development and resource allocation, protocol development, Investigator selection, subject eligibility and other associated tasks Site management and case management needed to be more effective by developing expeditious ways to track site visits, subject enrollment, study progress and payments to investigators and monitors Access to study data, internal and site operations and adherence to milestone achievement were not standardized and available to all users at all times Communication with CROs in many countries needed standardization with templates for complete and accurate critical information exchange and assured distribution to all study personnel involved Data integration across different EDC systems needed improvement Reports and communication required process improvement and standardization A quick and convenient method was needed to add customized add-on modules when needed There was costly, inadequate integration of data between clinical operations and business units Solution It was clear that the existing systems were state-of-the-art and met or exceeded all industry standards and regulatory requirements. However, the company needed additional tools to maximize the features and benefits of Siebel. Our recommendation was to build and install a customized version of AccelCTMS, fully integrated with and powered by Siebel Clinical. Techsol’s AccelCTMS accelerates clinical development by providing customized enablement tools including: Ability to collect and organize clinical trial information from all sources and provide cloud storage for all users real-time access Elimination of many manual procedures to automate, standardize and manage case work flow Preconfigured templates for off-the-shelf reports and standardized communications Multiple EDC systems compatibility and integration was lacking Flexibility to modify existing features and to add new modules Techsol performs implementation, validation of all elements, training and 24×7 technical support. The system is FDA Title 21 CFR Part 11 compliant and hosted on our fully managed, secure private cloud. Result The client gained many favorable results by working with Techsol on the efficient implementation of CTMS: A high comfort level was achieved for all client end users and business associates The client participated in the development of the support plan and approved all terms and conditions The disaster recovery plan was developed to meet all Federal, State, and local laws and regulations 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

Our client is a global pharmaceutical company with revenues of $ 4 billion and is the fifth largest specialty generic pharmaceutical company in the world, providing high-quality affordable medicines in over 150 countries. In the US market, which contributes a significant share of revenues, they are a leader in the generic dermatology and complex product segments.

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 Enhancing Clinical Trial Performance with an Innovative Clinical Trial Management System Accelerator appeared first on Techsol Life Sciences.

The post Enhancing Clinical Trial Performance with an Innovative Clinical Trial Management System Accelerator appeared first on Techsol Life Sciences.

]]> Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals https://www.techsollifesciences.com/case-studies/axis-clinicals-ltd/ Thu, 29 Dec 2022 10:25:02 +0000 https://www.techsollifesciences.com/?page_id=7852 Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and configuration. Challenge Solution Result Challenge Axis Clinicals conducted a regulatory risk assessment and determined that ClinSpark system was required to be implemented. For this implementation, there were some challenges ahead. It was required to configure ClinSpark as it was a turnkey, enterprise-level system. Existing Axis Clinicals workflows and documentation needed to be modified to accommodate ClinSpark’s enhanced capabilities. Validation of technology, workflow process, governance and control was required. Solution Techsol partnered with Axis Clinicals to assist in various tasks required to define the system for Axis’s use. Our team analysed the system requirements, implemented the requirements, integrated instruments as required and tested the system, with associated documented evidence. The project was completed in 20 weeks from initial discovery to official deployment of the system for operational use. Techsol coordinated with Axis Clinicals and Foundry Health, owners of ClinSpark, through onsite workshops to understand the objectives of the project. We worked with Foundry Health team to understand the technical architecture, functionality, configurability, modes of maintenance of ClinSpark. Our team got trained on the system by experts at Axis Clinicals. Result The efficient execution of the project brought many favorable results for the client Human errors were reduced by 85% The cost was reduced by 40% The amount of work was reduced by 60% 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 Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals appeared first on Techsol Life Sciences.

The post Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals appeared first on Techsol Life Sciences.

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Business Meeting

Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and configuration.

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 Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals appeared first on Techsol Life Sciences.

The post Implementation and Validation of Phase 1 Clinic Automation System for Axis Clinicals 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

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.

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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.

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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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