DSG - The FSP Imperative

I regularly visit both sponsor companies and CRO partners and I am often amazed at the lack of knowledge about the functional service provider (FSP) model for eClinical software and clinical data management. Despite the multitude of articles and vendor information on the benefits such a model has for sponsors, many are befuddled as to how this can truly help increase efficiency, reduce error and reduce costs in your next clinical study. Here’s my take.

The FSP model promotes both an opportunity to create operational efficiency while promoting accountability, improved quality and experience. Sponsors who adopt the FSP model implement processes which provide a team structure and management oversight of multiple providers that result in similar efforts to managing a single provider. Sponsors implementing an FSP model promote transparency and sponsor control of the study. The reluctance of many small to mid-size companies to embrace this model remains a mystery although time spent overseeing and managing multiple providers is usually the most cited reason.

FSP promotes an experience that provides flexibility, collaboration, improved response, and demands accountability while reducing costs. It also rewards the sponsor with choosing their preferred and best-of-breed provider for a functional area rather than be subjected to team members of a larger group that may or may not provide the proper level of expertise needed. In eClinical systems, especially for EDC software, it allows for standardization and consistency in implementation and conduct outside of the industry standards such as CDISC while fostering relationships and defining working processes.This leads to more rapid deployment and conduct of a clinical study or program which ultimately leads to approvable products to market faster which is the goal of all life science companies.

Sponsors who have mastered the FSP model stick with it. Industry migration is not in the other direction, from FSP to full-service CRO model – the aforementioned is why.