Transformational Relationships: How a Consultative Approach from a CRO Adds Value to Your Development Program

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. Through the 1990s, sponsors required a more sophisticated offering from CROs who were required to master fundamental study operations and processes, offering scalability to sponsors’ operations departments. As innovative science targeted more nuanced patient populations in the 2000s, CROs were required to anticipate a sponsor’s needs, forming sponsor-CRO relationships which would evolve into true “partnerships” in the next decade. Today, we see the need for innovative and strategically focused CROs that appreciate the value of the sponsor’s assets and can guide the optimal development route, integrating science and methodology with regulatory affairs and operational excellence. These new partnerships transcend traditional commercial relationships, which limit the ability of a CRO to add value to a development program. Instead, a CRO offering consultative services and strategic development elevates the full development program. The Benefits of Early Engagement The most successful sponsor-CRO partnerships begin with early engagement during the outsourcing process, which enables a more systematic and thorough evaluation by the sponsor and allows the CRO to develop the optimal operational strategy. From those early conversations, the engaged CRO members can ensure the goals and assumptions of the sponsor are integrated into the proposals and planning activities...
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