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Reagan-Udall Foundation for the FDA COVID-19 Therapeutics Research Questions Project Management

Reagan-Udall Foundation for the FDA COVID-19 Therapeutics Research Questions Project Management

Opportunity

The Reagan-Udall Foundation for the FDA (FDA Foundation) partnered with two organizations to conduct observational studies that leverage real-world data to: 1. Describe the utilization and pattern use of mAb and identify key characteristics of COVID-19 patients who have been administered mAb for COVID-19 treatment in the outpatient setting. 2. Characterize vaccinated patients hospitalized with COVID-19 and describe the incidence of vaccinated patients with breakthrough infections, including time since vaccination. The FDA Foundation needed project management support to complete these projects.

Our Solution

Alecia served as the project manager for the project, assisting with refining the project approaches, contracting, invoicing, and the timely completion of high-quality deliverables. Alecia leveraged her project management experience, knowledge of real-world data, and knowledge of identifying COVID-19 and related outcomes in observational data sources to facilitate the successful completion of these projects.

 

“Alecia applied her knowledge of real-world data to support the FDA Foundation in the successful completion of these projects, which resulted in the delivery of two reports to the FDA.”

-Amar Bhat, Ph.D.

Chief Operating Officer FDA Foundation

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