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 provided pre-award. They also think beyond the single study being discussed to anticipate future needs, supporting a matrix of engagements.
During early engagement, our sponsors have access to therapeutic strategy leads, scientific solutions, and clinical research methodology experts committed to their indication to establish a strategic alignment that will continue throughout the development program. Our tenured and experienced teams work alongside sponsors to pressure test sponsor plans based on lessons learned from previous development experience.
Transformational relationships exist at the intersection of science and operations. When executed correctly, early engagement is a period of transformative relationship building between a sponsor and the CRO they must trust to execute their study with care and precision. It’s a time for the CRO to prove their expertise in methodology, strategy, and operations and for the sponsor to gain the perspective needed to commit confidently to a CRO.
Consistency is Key
As CROs continue to be the subject of mergers and acquisitions, the regulatory environment becomes more complex, and demands on sponsors grow. Sustaining a strategic approach during the turmoil of joining two companies has proven difficult, and many sponsors have felt the impact of the fallout from such a union on their trial. In contrast, Worldwide Clinical Trials is dedicated to maintaining our midsize, which has proven to be flexible and consistently supplying the true, strategic partnership our sponsors need. This approach has been integral to our philosophy since our founding in 1986.
Our strategic relationship is transformational for our sponsors. See how to unlock the full power of your CRO partner in our white paper, Optimal Outcomes in Clinical Research and Product Development.