Working with Clinical Research Organizations
June 9, 2009
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.