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ICH Emphasizes Need For Quality In Clinical Trials

 
• By Vibha Sharma

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.

The revised guideline, E8(R1), replaces the version that had been in place since 1997 and incorporates the most current...

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