FSP vs Full-Service: Which Engagement Model Fits Your Clinical Project?

Choosing between a Functional Service Provider (FSP) model and a Full-Service engagement is a strategic decision. The right fit depends on your internal capabilities, timelines, budget, and risk tolerance. Here’s a practical comparison—plus guidance on when to use which.

Two Models, Different Strengths

In an FSP model, you contract specific functions—such as CDM, statistical programming, or biostatistics—while retaining oversight and integrating providers into your processes. The Full-Service approach outsources end-to-end workstreams to a single partner for cohesion and accountability.

Neither is inherently better. The best model is the one that advances your objectives with the fewest coordination costs and quality risks.

FSP Model: Pros and Cons

• Pros: precise control over functions; flexible scaling; easy to augment internal teams
• Cons: higher coordination burden; risk of process mismatches across vendors; oversight load remains with sponsor

Full-Service Model: Pros and Cons

• Pros: unified processes; single point of accountability; fewer cross-team handoffs
• Cons: may be costlier; less granular control; switching mid-study can be harder

“Strategy is about making choices, trade-offs; it’s about deliberately choosing to be different.”— Michael E. Porter

Signals You May Prefer FSP

• You have strong study management and want to retain functional control
• You need to flex headcount quickly without long procurement cycles
• You run multiple vendors and are comfortable orchestrating them

Signals You May Prefer Full-Service

• You want a single accountable owner across functions
• Your timelines are tight and cross-functional rework risks are high
• You’re entering a new therapeutic area or regulatory pathway

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