Rethink Your Study Team To Reimagine Your TMF

For the last several decades, clinical study teams have been structured according to the Full-Service (FS) and Functional Service Provider (FSP) outsourcing models. [1][2][3] The FS and FSP outsourcing models have grown in tandem with the prevalence of CROs and have been the main catalyst for their growth.

While the advantages and disadvantages of outsourcing are frequently debated, less common is discussion of how these outsourcing models end up shaping the sponsors who adopt them. When a business process becomes outsourced, it must be parsed into the language of customer and vendor. Instead of organizing around roles, responsibilities, and goals, study teams have been reorganized based on the services offered—whether or not that team structure is what’s best for the function of a study team. The result of these mismatched incentives is that the modern, decentralized study team struggles to unite behind the TMF, which requires exacting cross-functional coordination for success.