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Good Clinical Practice

Nov 2024

Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease

By |2024-11-25T15:21:25+02:00November 25, 2024|Blog, Good Clinical Practice, News|Comments Off on Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease

Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.

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Oct 2024

Navigating ICH E6(R3): New Standards for Medical Monitoring

By |2024-10-31T10:30:22+02:00October 30, 2024|AI in Clinical Trials, Blog, Good Clinical Practice, News|Comments Off on Navigating ICH E6(R3): New Standards for Medical Monitoring

Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.

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Sep 2024

EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science

By |2024-09-19T14:22:20+02:00September 19, 2024|AI in Clinical Trials, Good Clinical Practice, News|Comments Off on EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science

The EMA has released key guidelines on the responsible use of large language models (LLMs) in regulatory science. Discover how AI tools like GPT can streamline tasks while addressing privacy and accuracy challenges, and learn about the EMA’s approach to safe and ethical implementation.

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Sep 2024

Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

By |2024-11-25T19:43:54+02:00September 11, 2024|Free Infographics, Good Clinical Practice, News|Comments Off on Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).

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May 2024

Decoding Sponsor Responsibilities in ICH E6(R3)

By |2024-11-25T19:50:50+02:00May 20, 2024|Good Clinical Practice, News|Comments Off on Decoding Sponsor Responsibilities in ICH E6(R3)

Discover the potential impact of the draft ICH E6(R3) guidelines on sponsor responsibilities in clinical trials. Download our free infographic for a comprehensive overview.

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Dec 2023

Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

By |2024-11-25T17:26:20+02:00December 4, 2023|Blog, Free Infographics, Good Clinical Practice, News|Comments Off on Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

Explore the impact of ICH's Q9(R1), Quality Risk Management, guideline on RBQM and clinical trials in our latest blog post. Don't miss our free infographic that simplifies this complex guideline. Enhance your risk strategies today!

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May 2023

Training Implications of the ICH E6(R3) and E8(R1) Guidelines

By |2024-09-11T16:49:40+02:00May 29, 2023|Blog, Good Clinical Practice, News|0 Comments

Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.

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May 2023

A Comparative Review of the ICH E6(R3) and E8(R1) Guidelines

By |2024-09-11T16:55:48+02:00May 26, 2023|Blog, Good Clinical Practice, News|Comments Off on A Comparative Review of the ICH E6(R3) and E8(R1) Guidelines

Unpacking the new ICH guidelines, E6(R3) and E8(R1), we illuminate their key elements, identify gaps, and compare the two in terms of their unity, differences, and complementarity.

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Feb 2023

Reflections on ICH E6(R3): Insights from SCOPE Summit 2023

By |2024-09-11T16:56:32+02:00February 13, 2023|Blog, Good Clinical Practice, News|Comments Off on Reflections on ICH E6(R3): Insights from SCOPE Summit 2023

Exciting news on ICH GCP E6(R3) is here! Our CEO, Artem Andrianov, returned from the SCOPE Summit with updates on the updated guideline. ICH E6(R3) will incorporate technology advancements while prioritizing participant protection and reliable evidence. Don't miss Artem's thoughts on his experience at the summit. Stay tuned for more updates on ICH E6(R3)!

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Apr 2022

ICH E8(R1) General Considerations for Clinical Studies

By |2024-09-11T16:57:00+02:00April 8, 2022|Good Clinical Practice, News|Comments Off on ICH E8(R1) General Considerations for Clinical Studies

With the release of the final ICH E8(R1) version this month, sponsors and CROs are encouraged to embrace a Quality by Design culture. This final paper is part of a more general Good Clinical Practice (GCP) “Renovation” that involves the modernization of ICH E8 and subsequent renovation of ICH E6.

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