Creating a Successful CRO-Sponsor Relationship through Alignment of Goals and Values

Abstract

A pharmaceutical sponsor that contracts out a clinical trial entrusts a contract research organization (CRO) and its employees with a significant part of its drug development program. The outcome of this decision can have far-reaching consequences for the sponsor's future business success. To guarantee that the CRO will complete the project as the sponsor wishes, an alignment of goals and values between the two corporations must be created and maintained. This process can begin through contracts and strategic alliances but is only fully developed through project management interactions.

A contract is a legal instrument that provides the framework for alignment but has little motivational impact on project team members, many of whom are unaware of the specific contents of the contract. Strategic alliances, which can take the form of short-term or long-term financial incentives, and established team programs, are more likely to motivate alignment. As team programs are put in place, the CRO's employees are inevitably confronted with the sponsor's goals and values. During phases of the project cycle such as product definition, project planning, project monitoring, and project corrections, a gradual assimilation of the CRO's team members can occur if channels of communication are established between the two companies. Eventually, the CRO's team members are integrated into the overall vision and mission of the sponsor's development program. At this point the values of the two corporations have come into alignment.