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Designing an Effective Clinical Trial

Date | Mar 7, 2017 |
Time | 10:00 AM EDT |
Cost | Free |
Online
|
The discussion will provide best practices and tips on getting the most out of communications with the FDA. Other topic areas include:
- Making the most of feasibility studies
- The critical importance of pilot studies
- Common pitfalls in the design and conduct of pivotal trials
- Development and negotiation of non-inferiority margins in a non-inferiority trial
- Some important aspects of investigational site selection
- Communicating with FDA during the pre-submission and submission process
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