This collection explores current GCP regulations and guidance shaping clinical trial oversight, including ICH E6(R3) and evolving regulatory expectations. The articles focus on how trial sponsors interpret and apply regulatory requirements in practice, with attention to accountability, risk management, and quality oversight.
ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era of clinical compliance focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes familiar […]
