Apr2022

ICH E8(R1) General Considerations for Clinical Studies

April 8, 2022|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.

Mar2021

4 Ways to Optimize Vaccine Trials in Coronavirus Variants

March 15, 2021|Comments Off on 4 Ways to Optimize Vaccine Trials in Coronavirus Variants

Learn how risk-based quality management (RBQM) helps simplify coronavirus vaccine development and helps mitigate any unnecessary burden from clinical organizations ensuring vaccines are readily available when needed.