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Activity Number: 131 - Topics in Clinical Trials
Type: Contributed
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #301837 Presentation 1 Presentation 2
Title: Challenges of Filing Externally Conducted Clinical Trials
Author(s): Kenneth Liu* and Jonathan Hartzel
Companies: Merck & Co., Inc and Merck & Co., Inc
Keywords: SDTM; Collaboration
Abstract:

Many clinical studies are performed by non-pharmaceutical organizations. When these externally conducted clinical trial are included in a regulatory filing submission, challenges can arise.

This presentation will discuss many examples of challenges that can arise when externally conducted clinical trial are used in a regulatory filing in the context of an Ebola vaccine.


Authors who are presenting talks have a * after their name.

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