The hybrid FSP/full-service model is gaining traction in clinical research, but what is it and how can you make the most of it? Here we explore what FSP and full-service looks like, how they come together and how you can reap the benefits.
Given the rising costs of clinical research, the increasing complexity of trials and growing competition in the market, biotech and pharma companies need to stay agile and efficient. These are some of the factors that have been driving the rise in the Functional Service Provider (FSP) model in clinical research, taking over from the more traditional full-service model.
For many companies, though, it’s not such a black-and-white decision. A small biotech that’s growing might need a third option when it reaches a critical size. Or a pharma company looking to expand research internationally might need flexibility and stability to take the next step. This is where a hybrid model can be helpful.
Hybrid FSP and full-service models combine the stability and support of a full-service model with the agility and flexibility of FSP. At Siron Clinical, we have been offering customizable hybrid approaches for two decades, giving our clients maximum expertise and efficiency while they retain control of the process.
In this blog post, we look at what a hybrid model can look like, and how to implement a hybrid model for optimal results.
How Do FSP and Full-Service Come Together?
The Functional Service Provider (FSP) model is a flexible approach to contracting: customized clinical trial services are offered on a functional basis. The sponsor can outsource functions, such as clinical monitoring, to the CRO, rather than handing over end-to-end operations.
The FSP approach has a number of benefits, most notably flexibility and control. The sponsor determines the tasks and functions they need support for, and they retain control of the overall process. This enables the sponsor to manage the trial budget and retain oversight, thereby mitigating risk and strengthening compliance.
The more traditional CRO partnership is full-service, in which the CRO provides end-to-end trial management services. In this model, the sponsor contracts out the clinical research to the CRO, largely delegating control but retaining ultimate oversight of the trial.
The full-service approach can lighten the workload on the sponsor organization, as the CRO takes on the operational side of the research. With just one point of contact, the sponsor organization benefits from fewer handoffs and more streamlined processes.
There is a third option: the hybrid model, which we refer to as customizable FSP at Siron Clinical. This gives the sponsor the control of FSP and the integration of full-service, and since it is customizable, it can be adjusted to fit the sponsor’s needs. In general, the partnership will be a combination of outsourced functions and integrated services. For example, the sponsor might have a full data management team but need support for patient recruitment, as well as full support in an offshore region.
The hybrid approach is gaining popularity, especially among small and mid-sized sponsor organizations. According to the 2025 FSP Trends Report, FSP alone remained stable between 2023 and 2024, with an increase in preference for hybrid and a decrease in full-service.
Trials that Benefit from Customizable FSP
Customizable or hybrid FSP can provide excellent benefit in a range of trial types and therapeutic areas. Here are some examples of trials where sponsors choose this more flexible approach, and why.
Global trials with local needs
A global sponsor might be set up with a full clinical trial team in one or more countries, requiring support for individual tasks or functions in those areas. But if they are running an international trial that includes sites in countries where they don’t have a presence, they may need more integrated support in those places, especially to ensure compliance with local regulations. In cases like this, a combination of FSP and full-service support is ideal.
Studies with a small participant pool
One of the biggest challenges in clinical research is participant recruitment and retention, and that is especially the case for rare disease studies. Clinical trials in this therapeutic area can be unpredictable, and even if a full-service approach is chosen, they may require the additional flexibility of FSP. Hybrid or customizable models provide this possibility.
Growing sponsors and expanding trials
A sponsor organization that’s small at the start of its journey might grow in terms of the scope of research and the in-house capacity. Early in its journey, the sponsor would likely benefit from FSP services, enabling them to outsource functions and tasks with flexibility. As they grow, expanding their team in certain areas, they may have greater scope to outsource elements of the trial in their entirety, such as project management and clinical monitoring. Customizable FSP can grow with sponsors like this.
In all of these cases, and many more, hybrid FSP gives the sponsor organization better control of their budget, and an accelerated timeline. It also improves efficiency and ensures the sponsor retains critical oversight of the process.
How to Make Hybrid FSP Work for Your Trial
Whatever your size, trial type or therapeutic area, there are certain steps you can take to maximize the positive impact of a hybrid or customizable FSP approach.
Map out your requirements
Look carefully at the functions, tasks and expertise you need to succeed with your trial, including where they need to be geographically. Then compare this to your in-house capabilities. The gaps you identify can help you define the support you need from a CRO partner.
It’s also helpful to look at this over time – predict where the gaps will be, not only in the short term but also the medium and long term. This will enable you to predict growth in the partnership as well as in the trial itself.
Build effective communication and governance
As we have explored in a previous article, good communication is key to a successful customizable FSP partnership. This means being clear about communication approaches from the very beginning, establishing a clear structure for communication and governance, and adapting as you go along. This is true for any sponsor–CRO partnership, but especially so for hybrid or customizable FSP. Collaboration is vital to success, and good communication and governance can strengthen the pursuit of shared goals.
Tap into the CRO’s expertise
When you work with a CRO on a customizable FSP basis, you will benefit from their expertise in three ways: at the task level, across the therapeutic area and for compliance. At the task level, the CRO will bring their knowledge and experience to your clinical trial, and through the full-service integration elements, this can be transferred to your team. Even if you don’t delegate compliance directly or leverage therapeutic knowledge on a functional basis, this expertise will be available as your engagement evolves.
Involve the CRO in shaping the partnership
You don’t need to set out all the parameters before engaging a CRO; lean on their operational expertise and build the model together. At Siron Clinical, we have worked with customizable FSP for 25 years, so we understand how to design the optimal partnership.
Leveraging Customizable FSP for Your Trial
For sponsors that need predictable costs, strong integration, flexibility and control, hybrid or customizable FSP is an ideal option.
At Siron Clinical, we offer Customizable Functional Service Provider (FSP) support – a flexible hybrid FSP model that allows sponsors to start with selected functions to fit the needs and budget of the trial and eventually expand to full-service CRO capabilities, if needed, without changing personnel. This approach helps sponsors stay on track, on time and in control.
Find out how Siron Clinical’s Customizable FSP support can help you succeed with your clinical trial.
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