Clinical Development
Sponsor Responsibilities Under ICH GCP E6: The Non-Negotiables for CRO Oversight
In the rapidly evolving landscape of clinical research, sponsors are under increasing pressure to conduct efficient, high-quality trials that meet stringent regulatory standards. The International Council for Harmonisation’s Good Clinical Practice (ICH GCP) E6 (R2) guidelines and the forthcoming E6 (R3) update outline the multifaceted responsibilities sponsors bear throughout the clinical trial process. Central to…