Risk-Based Monitoring: A Regulatory Perspective on What's Expected from an Independent Assessment of Data
Recorded on March 25, 2014
This webinar recording provides a regulatory perspective on what is expected from an independent and objective assessment of clinical data.
Discussion points include;
- What the FDA and EMA are encouraging sponsors to look at as part of their assessment of data quality
- Identifying the different types of data analysis required to de-risk studies
- A review of case studies that exemplify a powerful approach to data management
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