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April 2017

ICH E6 (R2) – Miracle Pill for the Clinical R&D Industry

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ACRP Clinical Researcher

ICH E6 R2 – Miracle Pill for the Clinical R&D Industry

Steve Young, Chief Operations Officer, CluePoints

Publication of the long-awaited ICH E6 (R2) Guideline this year finally makes it official.  A risk-based approach to clinical trial quality management – commonly referred to as risk-based monitoring or RBM – is now a codified GCP expectation for the industry.