Implementing a Proactive Approach to Risk Management

Sponsors running clinical research studies confront enormous pressures today. From complex study designs, industry cost constraints, new geographical locations and significant technological advancements, there are many challenges to face. The International Council for Harmonization (ICH) efficacy guideline on Good Clinical Practice (GCP) aims to help sponsors keep up with these major shifts and implement improved practices in the industry. This article discusses how the ICH has changed with the recently approved revision E6(R2) and outlines some of the major areas where sponsors can develop more efficient approaches in the design and conduct of their clinical trials.