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Working with Clinical Research Organizations
June 9, 2009
View the Program Flyer here.
Epstein Becker Green (“EBG”) and Pfizer
co-hosted a dynamic and timely Coffee, Croissants and CLE
Program at the firm’s New York City office. EBG partner
Bradley Merrill Thompson and Robert R. Arreola, Esq., Director, Pfizer
Contracts and Outsourcing led the discussion.
The presentation, entitled Working with Clinical
Research Organizations (CROs) examined how and why drug
companies are increasingly turning to CROs to conduct various aspects of
clinical trials. Mr. Arreola discussed the general receptive
environment to CROs, the various methods of outsourcing clinical trials
and how Pfizer goes about selecting and maintaining relationships with
CROs. He identified pros and cons of various outsourcing models,
and addressed some of the challenges clinical trial sponsors face when
outsourcing to CROs. Mr. Thompson examined legal issues confronting
clinical trial sponsors when contracting with CROs to conduct work that
was previously performed internally. He highlighted potential risks,
such as site management, change orders and staffing issues, and offered
practical solutions to managing and resolving these risks.
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