Clinical development outsourcing is evolving. While functional service provider (FSP) models have been around for more than 20 years, today’s strategies bear little resemblance to their early counterparts. Originating as staff augmentation for discrete functions within clinical operations and data management, FSP outsourcing helped sponsors efficiently manage the ebb and flow of workforce needs. Early models typically featured uniform components of common staff functions, fixed rate pricing and quality oversight from the sponsor. Over time, however, these have significantly evolved to combine features of multiple outsourcing approaches. Today’s models offer greater flexibility spanning virtually every functional discipline, with different pricing and operational components. They are increasingly customized to sponsors’ needs, flexing with fluctuating outsourcing patterns.
Preferences have shifted, due to ever-increasing demands for more efficiency, innovation and fundamental change.
Early models focused on fulfillment of clinical research associates – a well-defined, high-volume need. In the mid-2000s, FSP interest surged when sponsors recognized the value of resource flexibility, allowing for quick movement of critical roles across portfolios or studies. Flexibility was critical at a time when many sponsors didn’t have recruitment teams or easy procedures for renegotiating contracts when they needed to scale back.
The decade ended with a shift back to full-service outsourcing. Successful FSP collaborations required changes sponsors and CROs weren’t ready for, including close management of FSP workforces by sponsors, and different approaches to oversight and governance.
The next iteration of FSP models offered CRO delivery responsibility in addition to administrative oversight. While hub-based teams had been a long-standing fixture of the FSP model, the use of remote teams increased. Pricing began to include unit-based options for projects involving well-defined milestones, such as study start-up. The use of CRO systems and processes broadened FSP appeal to smaller organizations lacking infrastructure. Design soon expanded to focus on targeted needs beyond functional disciplines, including therapeutic portfolios, specific geographies and development phases.
Today, outsourcing preference is shifting from full-service to FSP models and hybrids of both – a trend confirmed by recent research from the AVOCA group which concluded FSP models deliver on increased resource flexibility, collaboration, expertise and control of study outcomes.
As outsourced drug development continues to mature, pressure to modernize clinical development with flexibility and speed will be greater than ever. Current FSP approaches represent a logical next step to more efficient trial management.
Key considerations when evaluating FSP outsourcing models:
- Do you have a defined FSP model structure? Does your team have experience working in it? Do you need consultative support to develop a model?
- Are you looking to outsource a new function, consolidate vendors, expand geographically, accommodate demand for additional resources, or seek a more cost-effective solution? Do you have expertise gaps?
- What is the anticipated volume and cadence of work?
- Do you have preferred systems and processes? Are you looking to use provider ones?
- What level of oversight do you expect to retain? What oversight do you expect from providers?
Read more about FSP models on parexel.com.
ISR Reports, Clinical Development Outsourcing Models (3rd edition), 2018
2019 Avoca State of the Industry Report