FSP Models in Clinical Trials: Types, Differences & Key Considerations

Implementing a Functional Service Provision (FSP) model requires careful planning and collaboration between the sponsor and the Functional Service Provider. Understanding critical success factors and potential challenges helps maximise the benefits of FSP. FSP models are now commonly used across biopharma, particularly where teams need to add capacity quickly without building permanent infrastructure. By managing specific functions through an FSP, companies can optimise their operations.

What is an FSP Model?

An FSP model is an outsourcing approach where a sponsor partners with a provider to deliver defined functions (or parts of a function) using agreed ways of working, governance, and performance expectations, while the sponsor typically retains overall programme direction and decision-making. In practice, FSP support is often used for functions such as clinical data management, biostatistics, statistical programming, medical writing, and pharmacovigilance, depending on the sponsor’s needs.

How do FSP Models Differ from Full-Service Outsourcing?

FSP models typically focus on function-specific delivery, whereas full-service outsourcing (FSO) is usually used when a sponsor asks a CRO to take end-to-end responsibility for a study (or a large part of it) with a single point of accountability. The practical difference is usually where day-to-day coordination sits. FSP can give sponsors more control over priorities and decision-making, but it can also increase the sponsor-side coordination and oversight required across vendors and internal teams.

What are the Types of FSP Models?

‘Functional service provider’ is an umbrella term for several operating setups, which differ mainly in the delivery boundary, integration depth, and how the sponsor manages day-to-day. Common models include:

Full-service by function
The provider takes end-to-end responsibility for a defined function, such as programming delivery for a portfolio.

Dedicated FSP
A ring-fenced team that works exclusively on sponsor programmes, often embedded into sponsor systems and processes to support continuity.

Staff augmentation
Individual roles are added to supplement the sponsor team, typically to fill capacity gaps or short-term specialist needs.

Hybrid models
A deliberate blend of FSP and full-service delivery, where some scope is managed as full-service and other scope is delivered as function-specific support.

What are the Main Differences Between FSP models for Clinical Trials?

Teams typically choose between FSP models based on a small number of practical decision points.

• Integration depth – whether delivery happens inside sponsor systems/processes or via provider-led systems.
• Sponsor management load – how much day-to-day direction, review, and cross-functional coordination remains sponsor-led.
• Continuity and team stability – whether the model supports long-term team retention and programme context or is designed for shorter-term capacity.
• Commercial fit – whether pricing aligns with how work is consumed (stable volume vs variable demand).

Benefits and Limitations of FSP Models in Clinical Trials

Functional Service Providers (FSPs) can offer practical advantages for pharmaceutical companies, particularly where teams need to scale specialist capacity without hiring. FSP models can help sponsors scale specialist capacity without hiring, improve budget predictability where scope and demand are stable, and reduce churn when delivery teams are ring-fenced over time. By outsourcing non-core tasks, sponsors reduce infrastructure costs, streamline budgets, and improve financial predictability with set-cost agreements. FSPs can also accelerate project timelines, support delivery within agreed SOPs, and improve quality management while providing dedicated teams that ensure team continuity and minimise turnover.

Unlike traditional outsourcing, FSPs can foster long-term partnerships, improving efficiency across programs and optimising resource utilisation. They also offer greater control over deliverables in some setups. By transferring time-consuming tasks like training, onboarding, and administrative duties to FSPs, sponsors can focus on core research objectives.

However, the benefits are not automatic. FSP models can increase sponsor-side coordination across functions and vendors, and outcomes depend heavily on boundary clarity, governance discipline, and how well the team is integrated into day-to-day delivery. Some sponsors also find that the ‘right’ model varies by function: for example, stable, repeatable work may suit dedicated teams, while volatile demand may suit more flexible resourcing approaches.

Considerations When Implementing FSP Models

While FSP models offer a range of benefits, there are also several considerations that must be carefully addressed to ensure successful FSP partnership for both sponsor and vendor. We have summarised these in several key areas.

Clear Communication

Establishing open and consistent communication channels is fundamental to a seamless FSP partnership. This includes communication plans that outline expectations, escalation paths, and contact lists. Regular meetings also ensure transparency and prompt issue resolution. Implementing an FSP requires seamless integration with the pharmaceutical company’s existing processes and systems. This can present challenges, particularly when collaborating with multiple CROs that handle different functions. Ensuring the FSP team aligns with the sponsor's values and working culture is equally important, as a strong cultural fit enhances cooperation and mutual understanding. Additionally, when teams are located in different time zones or regions, structured communication protocols are vital to overcoming potential barriers and ensuring effective collaboration.

Portfolio

A portfolio will provide detail on the forthcoming workload for a particular company and is always driven by business goals. The information will form the basis on which an FSP relationship is shaped and will influence the overall timescale of the proposed collaboration, as well as enabling prediction of resource needs. It is beneficial to consider including a measure of probability for study occurrence and ensure necessary risk adjustment to resource is taken into account. Regularly reviewing and updating the portfolio ensures it remains aligned with evolving project requirements and strategic objectives.

Technology Alignment

Integrating the FSP's systems with the sponsor's infrastructure is essential for enabling seamless data flow and real-time collaboration. It is important to agree on technology platforms and clarify responsibilities for ownership, maintenance, security, support, and licensing. Teams should also address potential complexities in system compatibility through careful planning and coordination. Overcoming system silos within FSPs, where separate systems are used for different functions, can help prevent limitations on information flow and innovation. By breaking down these silos, the integration fosters greater collaboration, improves data accessibility, and encourages the adoption of new technologies across teams.

Where multiple biometrics functions are delivered by the same provider, teams can also reduce handoffs and rework by aligning assumptions, standards, and timelines across different functions.

Training

Implementing comprehensive training programs, including standard operating procedure (SOP) reviews, e-learning modules, and instructor-led sessions is important to ensure all team members are proficient in necessary processes and technologies. Tailored training programs address specific roles and may involve SOP reading, document reviews, and practical courses. Aligning a training matrix with the Responsibility Assignment (RACI) document ensures comprehensive activity coverage and consistency during updates.

Generalist Approach

While FSPs typically offer broad expertise across multiple functions, this generalist approach may not always meet the needs of clients requiring highly specialised input. Projects involving niche research or advanced technologies may demand a more tailored, expert-driven strategy to achieve the best outcomes. Ensuring the right alignment of skills and expertise early in the partnership is critical to meeting project goals. When depth in a specific area is a key success factor, sponsors should make that explicit during provider selection and role design, rather than assuming a generalist team will cover it by default.

Process and Standards 

Operational alignment is key to seamless integration of team members within an FSP relationship. Ideally, document clear delineation of roles and responsibilities across all parties, implementing a Task Ownership Matrix (TOM) and/or Responsibility Assignment document (RACI) that is agreed and accessible to all. The Standard Operating Procedures (SOPs) to be used should be determined and a gap analysis performed to identify any potential areas of risk and associated mitigation. Agree data standards to be implemented across the portfolio of work, taking into account any third-party data providers.

To ensure effective oversight and keep the partnership on track, establish governance structures at strategic, financial, and operational levels. Regular meetings and performance reviews play a key role in monitoring progress, maintaining alignment, and addressing challenges promptly.

While FSP allows sponsors to retain control over key functions, strong oversight is necessary to meet quality standards and milestones. This requires establishing clear expectations and monitoring processes. This is especially important where multiple vendors are involved, so handoffs and acceptance criteria remain unambiguous.

Data Integrity

To maintain high-quality data, it's essential to use standardised data models, such as those from the Clinical Data Interchange Standards Consortium (CDISC), to ensure uniform data formatting when integrating data from different sources. This facilitates smoother integration and reduces inconsistencies.

Regulatory Compliance

It is important to develop a robust compliance framework to mitigate regulatory risks to ensure adherence to regulations like the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States, especially when FSPs operate across different jurisdictions.

Costing Models

Working with FSPs to establish costing models that align with the strategic objectives and operational needs. Also choose from pricing structures such as fixed price, time and materials, or unit-based models. In addition, some FSP models are priced on an FTE basis, which can suit stable, predicable demand, while unit and output-based approaches can fit repeatable deliverables where volume fluctuates.

Scope Management

 It is important to define processes for managing changes in project scope to prevent budget overruns and ensure transparency. Agree what triggers re-forecasting, and how change is assessed and approved, so commercial discussions don’t lag delivery reality. 

Conclusion

 If you’re assessing FSP models, the decision is usually clearest when you define the function boundary, the governance you’ll run, and the commercial approach that matches how demand will vary over time.

Quanticate delivers tailored FSP solutions to optimise operations, reduce costs, and maintain the highest quality standards in clinical trial support. With proven expertise and a commitment to excellence, we help you achieve your strategic goals with confidence. Request a consultation to discover how we can support your success.