Case Study - Creating an Effective Functional Services Partnership

Background

Our client, a top 20 biopharmaceutical company headquartered in the US, faced significant challenges with their existing outsourcing approach for statistics, programming, and data management functions. They needed a solution that simplified oversight, improved operational efficiency, and provided scalability to meet their growing needs.

An advanced Functional Service Provider (FSP) model provides sponsors with precisely these benefits. By leveraging an FSP solution, sponsors can streamline oversight models and enhance operational efficiency, while ensuring flexible talent resourcing.

Challenge

The client was previously using a hybrid outsourcing solution, combining smaller full-service CRO and FSP arrangements with unit-based staffing through external agencies. However, this approach posed increasing risks due to local labor laws and created significant administrative burdens.

With plans to significantly expand their clinical trial portfolio, the client needed a scalable solution to manage the exponential growth in data management, statistical analysis, and programming requirements. Transitioning to a dedicated FSP model became essential for supporting their ambitious ramp-up plans.