ICH E8(R1) General Considerations for Clinical Studies

ICH E8(R1) Final Version Released on April 7, 2022

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.

Download the full paper here: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1)
Read also: How the New ICH E8(R1) Guidance Affects Your Clinical Operations
Free infographic: ICH E8(R1) the Infographic Way

By Linda Bunschoten - Chief Marketing Officer|2022-04-25T10:48:42+02:00April 8, 2022|News|Comments Off

About the Author: Linda Bunschoten - Chief Marketing Officer

Linda has 25+ years of experience uncovering pain points and strategizing with companies in the healthcare industry in order to secure and retain more clients. Her chief thinking responsibilities include translating insight into strategy and ensure that all MarCom and Product Management activities contribute to our overall customer experience and meet our industry’s quality expectations.