Contract Research Organization Agreements

Summary

This practice note provides practical guidance for negotiating and drafting an agreement between a drug company or medical device company (a sponsor) and a contract research organization (CRO) to design, monitor, or audit clinical trials. Outsourcing oversight responsibilities for clinical trials to CROs and other vendors has become common practice for sponsors who do not have sufficient resources to monitor their own clinical trials. A CRO agreement sets the ground rules for the sponsor-CRO relationship.