GCP

Feb 2023

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

By |2023-02-13T10:29:07+02:00February 13, 2023|Blog, 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)!

Apr 2022

ICH E8(R1) General Considerations for Clinical Studies

By |2022-04-25T10:48:42+02:00April 8, 2022|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.

Oct 2021

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2022-04-25T10:15:06+02:00October 17, 2021|Blog, Free Infographics|Comments Off on Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

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.

Dec 2017

Newsletter: Start 2018 with an easier way to manage your clinical risks

By |2017-12-13T13:58:18+02:00December 11, 2017|News|Comments Off on Newsletter: Start 2018 with an easier way to manage your clinical risks

100% SDV...seriously, who DOES this? Start 2018 with an easier way to manage your clinical risks.

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