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).
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.
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!
Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.
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.
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)!
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.
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
Today the ICH GCP Addendum E6 R2 comes into operation. Therefore, we summarized the useful resources for your kind perusal: GCP E6 R2 Addendum itself - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf PDF Mindmap of all GCP E6 R2 changes - https://cyntegrity.com/ich-gcp-addendum-e6-r2-mind-map-pdf-for-download/ ICH GCP Goes Risk Based - a [...]
The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted [...]
