Data Management & Biostatistics

Outsourcing in Clinical Trials September 30-October 1, 2020

Real-World Data and the FDA: How to Make Sure Your Data Counts
September 30 at OCT USA 2020

The growing use of real-world data (RWD) and real-world evidence (RWE) as an external control is a paradigm shift that sets the stage for new, more creative approaches to drug development. At the Outsourcing in Clinical Trials USA Virtual Conference, Premier Research will share practical tips for successfully using RWD and RWE in clinical trial submissions to the FDA.

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

  • 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

What’s challenging you today? Fill out the form on this page to schedule a consultation and earn an Amazon gift card.* Whether you have questions about the use of real-world data or something else, we’re always happy to help. Fill out the form on this page to get the answers you need. And since we can’t meet in person, we’ll say thanks by sending you a gift card for your time.

*Must attend scheduled meeting to receive gift card. $15 value.

Additional Resources

Entering a New Clinical Phase of Non-Traditional Data Sources

ASIST: Advanced Study Integrity Services Team

Can Your Clinical Data Strategy Keep Pace?