Featured Article

ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

The ICH E6(R3) draft guideline document, currently open to public consultation, places the industry firmly in the risk-based era, making it clear that the benefits of comprehensive operational oversight and targeted data management are in no way limited to the process of monitoring alone.

Guide

A Comprehensive Guide to Adaptive Site Monitoring

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Leveraging RBQM In Ways You Never Envisioned
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Risk-Based Study Execution (RBx) – It’s Time To Close The Loop!
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Decoding ICH E6(R3): What It Means for Risk-Based Quality Management (RBQM)
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