Case Study

SimulStat Delivers High Quality FSP Model With Sustained Efficiencies

The Challenge

A large global pharmaceutical company wanted to move away from resourcing statistical programming and biostatics services from a mixed model of providers and into a Functional Service Provider (FSP) model with a few preferred partners. The challenge was to build a team quick enough to help support a number of critical drug submissions in dire need of additional support. The customer’s goal was to create strategic partnerships with FSP providers so they would gain higher quality, efficiencies, and visibility into their clinical data.

The Solution

SimulStat was selected as one of the FSP strategic partners and immediately began building a team of highly experienced statistical programmers and biostatisticians to act as the foundation for the FSP. SimulStat’s extensive experience with FSPs enabled us to have an extremely streamlined onboarding process as we added FSP resources. Our customer immediately noticed the quality of the team and their ability to get up to speed quickly.

SimulStat’s commitment to effective and transparent communication with our customer served as a key component to the rapidly growing team, helping to manage the logistics of our new relationship.

SimulStat’s FSP Operations Team provided back-end support in terms of IT and overall administrative assistance to enable new resources to hit the ground running. SimulStat’s straightforward billing structure enabled our customer to effortlessly forecast and budget for continued growth and scalability of the FSP.

The Outcome

The initial team SimulStat put together doubled in size in a mere 4-month period due to our customer allocating additional budgeted FSP spend from a competitor’s budgeted pool. Our customer received regulatory approval for a blockbuster drug and our FSP team was a critical component in the submission and defense of the NDA. The partnership with our customer continues to evolve and progress today.


“We established a mutual and effective collaboration allowing us to support our expanding business.”

-Customer, Director of Statistical Programming

SimulStat FSP Highlights

  • Strategic partnership resulting in higher quality and efficiencies

  • Rapid scalability

  • Reliable resources making an immediate impact