By Rene Stephens, Managing Director
What’s missing from the conversation about these two models?
Within clinical development, outsourcing of clinical study activities is the norm vs. the exception, and there are multiple paths for sponsor companies to achieve their development and operational goals. Lately there has been quite a bit of discussion online about how outsourcing trends are changing. Two of the primary delivery models debated are Full-Service Outsourcing (FSO) and Functional Service Provider (FSP) outsourcing.
FSO includes activities performed by the sponsor (or its representative) in a clinical study, from protocol design to final Clinical Study Report (CSR) writing. The distinction here is that site-level activities involving patient/subject interactions are not in scope. That said, many FSO engagements will carve out key activities like protocol design, statistical analysis plan development, and, to some extent, investigative site selection. Nevertheless, people still refer to these sourcing models as “full service.”
FSP, in its simplest form, is the concentration and sourcing of specific functions performed during the clinical trial process, applied across a number of studies. Two predominate FSP examples are monitoring and data management, though there are other functions that can be individually outsourced.
The current buzz suggests there is a growing shift from FSO to FSP, but here’s the real deal.
Almost nothing new here – This isn’t a revolutionary trend, but rather a possible evolutionary trend. In some ways, it’s another swing of the outsourcing pendulum. The difference may be seen in more of a move to bring certain functions in-house while transitioning to FSP or niche sourcing. Functionally focused delivery has been around since the birth of CROs, thanks to pioneers like Sir Dennis Gillings and Dr. Hein Besselaar. At Danforth Advisors, our outsourcing specialists each bring 20+ years of experience navigating these cycles.
Big Pharma vs. Emerging Biotech – Most of the current conversation overlooks the unique needs of emerging biopharma companies, which often require different considerations than the larger players. We understand the difference, having worked in both large and small biopharma companies (plus service provider verticals).
Scale matters – FSP models rely on volume for cost savings. Smaller portfolios may not see the “savings” they expect.
Timing is critical – Switching sourcing models can mean significant lost time and money before value materializes. Let’s not jump the gun, as they say in track and field…patience is the key and commitment is crucial.
Governance complexity – FSP can require more oversight, adding resource demands for governance and relationship management for operations and outsourcing/vendor management functions.
Expertise needed – Vendor and outsourcing experts are essential to navigate selection, negotiation, and implementation smoothly (points to self!).
FSO issues don’t vanish with FSP – Transitioning to FSP doesn’t eliminate delivery challenges; it can sometimes lead to more finger-pointing and siloed functions if not carefully managed.
For smaller companies, FSP may seem like an attractive option, but managing it effectively can be challenging, and immediate savings aren’t guaranteed. Careful consideration is required.
At Danforth, our outsourcing experts bring extensive experience to ensure a model that truly aligns with your goals. Our “fit for purpose” approach is rooted in understanding where you are in your journey and delivering a model that meets your specific needs to hit critical milestones. Reach out now (before it’s too late!) and let us help find the right solution for you!