Real-World Data and the FDA: How to Make Sure Your Data Counts

Stacy Weil, Vice President, Clinical Data Operations, Strategic Business Optimization, and Kristi Miller, Ph.D., Vice President, Regulatory Affairs, address the following:

  • Expanded patient enrollment options when using RWD
  • New strategies for collecting and monitoring patient data
  • Recent regulatory reforms concerning acceptance of RWD
  • Case studies illustrating the use of RWD for regulatory purposes

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Additional Resources

Entering a New Clinical Phase of Non-Traditional Data Sources

Can Your Clinical Data Strategy Keep Pace?