Combining FSP and FSO Outsourcing Strategies
Dave Agrella, vice president, functional service partnerships (FSP), and Timothy King, executive director, FSP, write about combining outsourcing models to fit client needs.
Strategically selecting the right outsourcing model can bend the cost and time curve of drug development by achieving economies of scale and optimizing resource utilization. Today’s typical drug development model is being challenged to ensure life-changing therapies get to market faster and with lower research and development costs. For its part, PPD is leveraging its experience to help companies identify the right mix of service models to use. This includes supporting an internally run study via functional service partnerships (FSP), a completely outsourced study via full-service outsourcing (FSO) and conducting studies with hybrid approaches that include a mix of FSO and FSP strategies.
Core Features of FSO and FSP outsourcing models:
|FSO||FSP for insourced trials|
|Typically: Clients award to CROs on a study or protocol basis CROs provide multiple services for the awarded study, such as site ID and study startup, data management, clinical monitoring, drug safety and more often uses the CRO’s systems and standard operating procedures study is overseen by a project manager from the CRO contracts are milestone or unit-based||Typically: Clients award to a CRO by function CROs provide multiple services for the awarded study, such as clinical monitoring, data management, safety case processing and more, across numerous protocols often uses the client’s systems and standard operating procedures each study is overseen by a project manager from the client contracts are full-time equivalent based (FTE) or unit-based|
For many years, the industry tended to embrace one model versus the other. Over time, we have seen more clients invest in deploying both FSO and FSP models to maximize their ability to deliver life-changing therapies, a hybrid approach that gets the best of both models. Including a hybrid model in outsourcing strategies gives us the flexibility to create optimized, tailored solutions on a client-by-client basis that have the greatest impact on key operational metrics and deliverables.
Examples of Multiple Outsourcing Strategies
Client A: Studies are insourced in the countries where clients have affiliates with a significant dependence on FSP CRAs. Studies run in countries without client affiliates are FSO.
Client B: Metabolic studies are insourced using FSP CRAs, hematology/oncology studies use FSPs for data management and pharmacovigilance, while all other phase 2-3 studies are FSO.
Client C: A biotech client with FSO studies where they want certain key roles (project managers, CRAs, statisticians, medics, etc.) is wrapped into a 100 percent dedicated (ring-fenced) FSP contract that spans all protocols.
Importantly, there is an additional advantage delivered when we support clients with multiple and/or hybrid outsourcing models—it allows us to compare key performance indicators (KPIs) and key quality indicators (KQIs) across trials for the same client. We have found that this visibility is the backbone of successful productivity agendas which allow for significantly improved harmonization among studies.
Example KPIs we are tracking across models include:
|Site Startup||Turnaround times for site contracts, essential document collection, IRB/ethics approvals|
|Site Monitoring||Visits within window, trip report/follow-up letters in window|
|Data Management||Database build turnaround times, data backlog, query aging|
|Pharmacovigilance/Regulatory/ Marketed Products||Submission compliance to health authorities, case processing quality, percent acceptance of dossiers by regulatory agency with no validation errors (marketing authorizations and variations), major/critical audit findings|
Learn more about how combining FSP and FSO outsourcing strategies can benefit your company’s performance.