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Over the last few years, CluePoints has hosted a series of events in conjunction with TUFTS Center for the Study of Drug Development to bring together Research & Development leaders from Biopharmaceutical companies to gather experiences and insights on Industry response to the ICH's addendum to the ICH E6 Guideline for Good Clinical Practice (ICH E6 (R2). This paper takes a look at:
- Approaches to risk assessment.
- Risk-Based Monitoring and Digital Technology.
- Study design and oversight.
- Predicting risks & performance issues.
- The future of ICH E6 (R2).
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