The New Industry Migration Framework For FSP

By Glenn Boyet, Senior Director, Marketing & Communications, and Elias Tharakan, CTO and COO

For years, the industry has discussed the advantages and challenges of functional service provider (FSP) partnership models in clinical trials. Defined as a specialized provider of services, an FSP could ultimately be responsible for one or more services in the chain of tasks that altogether combined form a clinical trial, from protocol design and medical writing, biostatistical services, recruiting Sites and trial participants, collecting, and managing data and delivering an electronic submission to the agency.

Acting as general contractors, the proposed value for sponsors is that they won’t have to manage disparate FSPs as the CRO will do this for them. However, this discussion has primarily been led by the community most likely to be impacted by mass adoption.

In recent literature, writers have focused on the FSP model for clinical staffing (Byrth, 2018; Turesol Staffing Solutions, 2017) and clinical payments (Moore, 2017). However, there is no explanation or valid case made for the benefits of FSP over the full-service or preferred provider (PP) model from the point of the providers conducting the “functions” required under an FSP model.

Review why an FSP should be on the top of a sponsor’s list when choosing a specialized eClinical data management provider for its next study.