What is Functional Service Provision (FSP)?

FSP (Functional Service Provision) is a targeted outsourcing approach where a sponsor contracts external support for defined clinical trial functions. It’s commonly used to add specialist capacity without outsourcing an entire study.

This article explains what ‘FSP’ means in clinical research, how the model typically works, where it’s used, and what to watch for when selecting a partner.

What does FSP mean in clinical research?

FSP stands for ‘Functional Service Provision’. In practice, you’ll also see ‘Functional Service Provider’ used to describe the organisation delivering the service.

In clinical research, FSP generally means outsourcing specific functions (or parts of functions) to an external provider, while the sponsor keeps overall oversight and retains key accountabilities. The term is often used to distinguish function-level support from broader trial outsourcing models.

You may also see the term used more broadly as ‘FSO in healthcare’. In this context, that ‘healthcare’ framing maps back to regulated clinical research operations (trial delivery capabilities and resourcing), rather than routine delivery.

What is an FSP model?

An FSP model is an operating approach for delivering trial work through embedded functional capability rather than project-by-project outsourcing. Instead of buying a full trial team, the sponsor contracts for one or more functions, often delivered by a dedicated or semi-dedicated team aligned to the sponsor’s ways of working.

In practical terms, this tends to involve:

• A defined functional scope (what the FSP team will do, and what stays with the sponsor)
• Agreed interfaces (hand-offs, communication routes, escalation paths)
• Onboarding into sponsor processes (and sometimes sponsor systems/SOPs), so work is delivered consistently across studies
• Resourcing that can flex as priorities change (for example, by phase, portfolio demand, or geography)

The ‘how it works’ detail matters because the model’s value usually comes from continuity and integration, not simply moving tasks outside the organisation.

What is FSP used for?

FSP is commonly used when sponsors need to add capability without rebuilding permanent internal teams. In practice, it’s used to fill functional capacity or skills gaps (for example, when internal teams are stretched), while keeping sponsor oversight and established ways of working.

What functions are typically outsourced via FSP, and where does it show up across a study?

Commonly, the most commonly cited FSP functional areas include:

• Data management
• Biostatistics
• Clinical monitoring
• Regulatory affairs support
• Pharmacovigilance
• (Often also functions such as medical writing)

Operationally, teams also describe FSP being applied to specific delivery pinch-points or workstreams, for example:

• Site start-up activity where resourcing and local execution can affect timelines
• Patient recruitment support, particularly where local knowledge is useful
• Monitoring and data management workstreams, where consistent execution is critical
• Multi-regional execution, where sponsors may need to scale capacity and manage region-specific delivery needs

The key is that these are examples of the same underlying approach: contracting for functional capacity where it most improves delivery, rather than outsourcing the entire programme.

What should you look for when selecting an FSP partner?

Selection criteria cluster around one theme, being whether the partner deliver the function well while integrating cleanly into sponsor operations.

As such, practical points to evaluate include:

• When you assess an FSP partner, start by agreeing the scope and boundaries of what you want outsourced (and what you don’t).
• Look for relevant functional experience that matches the study types and delivery model you run.
• Pressure-test how the provider finds and deploys the right people, including how quickly they can respond when needs change.
• Ask how onboarding works in practice, including training, role clarity, and how the team aligns to your processes.

Finally, confirm how the partner adapts when priorities shift, so delivery stays predictable under real portfolio pressure.

This is less about glossy capability statements and more about whether the partner can operate as an extension of your function without creating friction at interfaces.

What are the limitations and trade-offs of the FSP approach?

Commonly noted limitations include the following:

• One risk is siloing (sometimes described as a ‘system island’), where functional teams become disconnected if ways of working and systems don’t align.
• Another is ‘generalist fit’, where resourcing doesn’t match the function’s complexity and consistency can suffer.

• A third trade-off is the ongoing sponsor oversight load, because retaining control still requires active governance, prioritisation, and review capacity.

These are manageable risks, but they are real. The more functions you split across different providers (or across internal and external teams), the more important your interface design becomes.

Conclusion

Functional Service Provision (FSP) can be a practical way to add specialist trial delivery capacity without rebuilding internal teams. The key is to be specific about what’s in scope, how hand-offs will work, and how you’ll maintain oversight day to day.

Need support scoping or delivering an FSP model for your clinical programmes? Quanticate helps sponsors resource critical functions with clear interfaces and governance that fit established ways of working. Request a consultation and a member of our team will be in touch.