Risk-Based Monitoring Goes Mainstream with ICH GCP E6 Revision 2

With the recent update to the ICH Good Clinical Practice (GCP) guidelines, risk-based approaches to clinical trials and risk-based monitoring are now requirements, not just recommendations. Now, sponsors and CROs alike face the challenge of adopting a formal approach to quality management which embraces technology and leverages access to real-time information to drive a more structured approach to risk.

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