When you outsource clinical trial delivery, the CRO model you choose shapes how work gets coordinated, where decisions get made, and how much oversight sits with your team. This article clarifies what ‘full-service CRO’ means versus an FSP delivery model, and what that changes for sponsor oversight and execution.
What does CRO mean, and what does FSP mean in a CRO context?
A contract research organisation (CRO) is a partner that supports sponsors with clinical trial activities, ranging from individual functions to end-to-end study delivery.
In a CRO context, Functional Service Provision (FSP) typically means outsourcing defined roles or functions (for one study or across multiple studies) while the sponsor retains more direct oversight of priorities and integration. In many FSP arrangements, provider staff operate as an extension of the sponsor team and work within sponsor systems and processes, which can support consistency across studies.
What is the difference between FSP and a full-service CRO model?
The simplest distinction is how delivery is structured and where accountability sits.
A full-service CRO model typically covers end-to-end trial delivery under a single provider-led structure, with integrated project management and a single point of operational accountability. An FSP model typically covers defined functions or roles, with the sponsor retaining more day-to-day control of priorities and cross-functional integration.
You may also see the term ‘FSO’ (Full-Service Outsourcing) used to describe full-service CRO delivery.
It’s also worth noting that ‘full-service CRO’ can be used in two ways. In this article, we’re referring to the delivery model related to end-to-end accountability and a provider-led operating setup. In other contexts, however, ‘full-service CRO’ is used to describe the breath of services a CRO offers (for example, covering clinical operations such as monitoring and patient recruitment as well as biometrics).
In this model, a full-service CRO typically supplies the delivery structure, processes, and systems across functions. The main attraction is operational simplicity and clearer end-to-end accountability for coordinating interdependent work. The trade-off is less direct sponsor control and slower change when priorities shift.
An FSP model, on the other hand, outsources specific functions or roles while keeping integration and priorities closer to the sponsor. In many set-ups, FSP staff work within sponsor tools and processes, which can support standardisation across studies. This can make it easier to add capacity where it’s needed. It can also increase coordination points, so clarity on roles and decision rights matters.
How do you choose between FSP and a full-service CRO?
Most selection logic comes back to sponsor capability and the level of oversight you want to retain.
Questions that typically help sponsors decide include:
- How much day-to-day oversight and visibility do you want over delivery?
- Do you have internal leadership bandwidth to coordinate functions and vendors, or do you need consolidated accountability?
- Are you aiming to standardise delivery through sponsor systems and processes across multiple studies?
- Is the main constraint end-to-end delivery capacity, or a specific functional bottleneck?
- Are you entering new geographies or operating with delivery complexity that makes integration harder?
Your answers usually point to whether you need a fully managed model for simplicity, or a functional model that gives you more control but requires stronger sponsor-side governance.
Whichever model you choose, define roles, escalation, and performance reporting early. Governance becomes more important as coordination points increase, which is common in FSP and hybrid models.
Can you combine FSP and full-service CRO delivery in a hybrid approach?
Yes. Hybrid approaches are common, especially when sponsors want end-to-end delivery for core trial operations while adding targeted functional capacity to remove bottlenecks or cover specialist needs. Hybrid approaches can add flexibility, but they also increase coordination points.
Conclusion
A full-service CRO model can suit sponsors who want consolidated delivery and clearer end-to-end accountability. An FSP model can suit sponsors who want to retain more direct control while scaling specific functions, provided they can support the governance needed to manage interfaces. Many programmes sit somewhere in between, using hybrid approaches that adapt by study, function, or complexity.
The most defensible choice is the one that matches your internal capability, oversight preferences, and where delivery risk sits.
Need support choosing between an FSP model and a full-service CRO for your clinical programmes? Quanticate helps sponsors define the right delivery model, align oversight and governance, and resource critical functions in a way that fits existing ways of working. Request a consultation and a member of our team will be in touch.
