Key “Critical to Quality” Factors in newly released ICH E8(R1) Guidance for Designing Quality into Your Clinical Trial
Clinical trials are incredibly important for bringing safe and effective treatments to market to help patients who need them. With that in mind, the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use just released the final adopted ICH Harmonised Guidelines of General Considerations for Clinical Trials release E8(R1). It is …