ICH Emphasizes Need For Quality In Clinical Trials

The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline. 

clinical trial progress
The quality by design approach to clinical research is a new concept introduced in E8(R1) • Source: Alamy

The International Council for Harmonisation has finalized much-awaited changes to its E8 Guideline on General Considerations for Clinical Studies, which is regarded as the foundational document for all clinical trials globally.

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