Author: Edouard Levasseur 
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Clinical Outsourcing Models
Three models, addressing various needs
Full-Service CRO: integrated execution
In a Full-Service model, a CRO coordinates a broad, often end-to-end scope for a study or program. This can include study synopsis and protocol wiring, study start-up (with prefeasibility, site selection and site contracting), as well as site management and monitoring, data management, biostatistics, safety, pharmacovigilance, regulatory support, trial master file management, or medical writing . The CRO typically provides the project-management structure, systems, and processes, while the sponsor focuses on strategic direction and oversight.
This model can fit sponsors with limited internal clinical operations infrastructure, complex multinational studies, or programs that need rapid access to an integrated team, making Full-Service outsourcing model also interesting for mature pharmaceutical and medical device companies. Its main advantage is consolidated operational accountability. The trade-off is that the sponsor has less direct control over day-to-day execution and must establish strong governance to retain visibility. Excelya settles clear governance with a clear point of contact, regular meetings, and a clear escalation path for transparency purposes, as we believe this represents a key factor of success in clinical trials and improves collaboration.
FSP: functional depth and continuity
A Functional Service Provider model supports one or more defined functions such as clinical monitoring, biological sample management, clinical supply & manufacturing, data management, biostatistics, pharmacovigilance, or medical writing, often across several studies. FSP professionals usually work as an extension of the sponsor’s team, within sponsor systems, SOPs, and governance.
FSP outsourcing model is more indicated for mid-size and big-size pharmaceutical or medical device companies, as we observe, overall, a better fit with sponsors that already have strong program leadership and infrastructure but need scalable functional capacity, specialist expertise or continuity across a portfolio. It preserves more sponsor control and institutional knowledge than a fully outsourced study. In return, the sponsor needs the leadership bandwidth to set priorities, integrate functions and manage dependencies.
Resourcing: targeted expertise at the point of need
Resourcing is one of the models with the most advanced granularity and reactivity, targeting specific expertise at individual scale. Individual professionals or small CRO teams join their efforts to sponsors’ teams to fill a defined role, capability, or temporary capacity gap. The sponsor directs their day-to-day work and remains responsible for integrating them into its processes and teams. At Excelya we maintain clear employer accountability to avoid any legal co-employment risks or consideration. Thus recruitment, compensation, performance management, development, and employment decisions remain solely under Excelya’s responsibility, ensuring effective mitigation of co-employment risk while supporting seamless collaboration with Sponsor teams.
This model can be effective when a critical vacancy threatens a milestone, workload rises temporarily, or specialist expertise is needed without creating permanent headcount. It can support speed and flexibility, but it does not replace program governance or cross-functional coordination.
Clinical Outsourcing Decisions
Four questions that should drive the decision.
01How complex is the trial?
Global, pivotal, or multi-vendor trials create high coordination demands and may favour integrated Full-Service delivery. If complexity is concentrated in one function, FSP or Resourcing may be more proportionate.
02What capabilities exist internally?
Sponsors with experienced leadership, mature SOPs and systems can absorb FSP or Resourcing more readily. Lean teams preparing a first multinational trial may benefit from a Full-Service structure. Sustained demand can justify dedicated capability; temporary demand may not. If there is a lack of systems or SOPs within your company, you would rather ask for Full-Service intervention model. If you want to apply your own system or SOPs, FSP or Resourcing would be a more adapted outsourcing model.
03How much control can sponsors exercise?
FSP and Resourcing keep work close to sponsor processes but increase direct management responsibility. Full Service reduces operational management, not sponsor accountability. ICH E6(R3) requires transferred activities to be documented, while ultimate responsibility for participant protection and reliable trial data remains with the sponsor. Oversight should reflect trial complexity and risk.[1]
04What is blocking delivery?
A CRO can mobilize an integrated study team, an established FSP can scale a recurring function, and Resourcing can fill a critical role. The fastest model is the one that removes the real constraint without creating new handovers or governance gaps.
Clinical Outsourcing Decision Framework
A practical decision matrix
Hybrid Models
About hybrid models: flexibility needs discipline.
Sponsors can combine models by study, function, geography, or development phase. A programme may use Full Service for launch, FSP for a recurring function and Resourcing for a temporary gap. Recent industry commentary identifies growth, M&A, rising complexity and fluctuating volume as triggers. Mixed models need one operating view, clear decision rights, a detailed RACI, and shared reporting to prevent blurred ownership and slow escalation.[2]
Choosing the Right Outsourcing Model
Start with the operating problem, not the contract.
Before selecting a model, sponsors should agree on five points:
- Which outcomes and milestones matter most?
- Which capabilities are strategic and should remain internal?
- Where is the real constraint: expertise, capacity, coordination, geography, or systems?
- Who will make decisions, monitor performance, and manage escalation?
- How will the model adapt if the portfolio or trial changes?
At Excelya, we support Biotech, Pharma and Medical Device companies and public institutions through Full-Service CRO, FSP and Resourcing solutions. Our role is not to force a program into a predefined model. We collaborate with sponsors to shape a fit-for-purpose approach around their capabilities, priorities and desired level of control then connect scientific, operational, and regulatory expertise through one team.
The right outsourcing model does more than provide resources or results. It creates clarity: the right responsibilities, the right expertise, and the right governance for the work ahead.
References
Sources and Supporting Evidence
ICH E6(R3), Sponsor sections 3.3, 3.6, 3.9 and 3.10: allocation of activities, agreements, service-provider oversight, and risk-proportionate quality management. Available at: ICH E6(R3), Sponsor.
Hadfield, S., 19 August 2026. Q&A: Why Sponsors Are Turning to Mixed FSP/FSO Models. Pharmaceutical Technology. Available at: Pharmaceutical Technology: Mixed FSP/FSO Models.
CASRAI Editorial Board, updated 24 August 2026. Clinical Trial Outsourcing: In-House vs. Full-Service CRO vs. FSP—A Sponsor’s Decision Framework. Available at: CASRAI Clinical Trial Outsourcing Decision Framework.
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