Functional Service Provider (FSP) models can offer biotech and pharma companies more flexibility in the support they get from a CRO while putting them in control. But is it the right choice for your trial? And how can you get the most out of this approach? This blog post explores FSP and its benefits for clinical research.
The COVID-19 pandemic had a significant and permanent impact on clinical research, in part due to the uncertainty and social restrictions driving a need for more flexibility. This need has continued to shape not only the way clinical trials are conducted – notably with decentralization – but also the services that support clinical research.
As a result, there has been a rise in Functional Service Provider (FSP) models among CROs, and it continues to grow: the global FSP market is expected to reach a value of US$29.62 bn by 2031, according to a 2024 report by InsightAce Analytic.
The benefits of FSP reach far beyond meeting the changing needs of an industry under pressure during a pandemic: FSP is on an upward trend in partnerships between biotechs and CROs, especially among small and mid-sized companies.
Why are FSP models rising in popularity? And how can biotechs maximize the potential they offer? Here we look at FSP in detail, outlining the ways this approach can support smoother operations and increase efficiencies, and how you can harness the benefits.
What is FSP?
Biotechs and pharma companies often work with CROs on a full-service basis, in which the sponsor contracts out the clinical research to the vendor, largely delegating control but not ultimate oversight of the trial. This is a good option in many cases, and it can be very successful when based on a strong partnership and good communication.
However, a full-service agreement may not be ideal, for example if there is limited budget or changing requirements. In these cases, a Functional Service Provider (FSP) model may be more appropriate. In an FSP arrangement, the sponsor can outsource specific functions to the CRO while remaining in control of the clinical trial and any data generated.
Traditionally, FSP has focused on clinical monitoring: a sponsor will work with a CRO on an FTE-basis, paying for the specific clinical monitoring support they need during the trial. But as FSP has evolved, so have the functions offered. This means sponsors can engage CROs on almost any aspect of running their clinical trial on a more flexible basis, from participant recruitment to biostatistics.
Today, with the right partner and an approach that meets the trial’s needs, sponsors can benefit from the flexibility, efficiency and quality the FSP model can provide.
Tailor the expert support you need: set clear requirements
One of the top benefits of the FSP model for sponsors is the access it gives them to specialists and experts in different aspects of clinical research. With an FSP agreement in place, a sponsor can strengthen their teams and capabilities as needed without having to hire people full-time. It is also often the case that large CROs will assign more junior staff to full-service contracts and more experienced or senior professionals to FSP projects.
To maximize this benefit, biotechs and sponsors could be specific about their requirements during their search for a vendor. For example, if you’re looking to bolster your data management activities specifically, ensure this is a key consideration when selecting a CRO or another partner. This will put the focus on the skills and experience that best match your requirements and help shortlist vendors that are experts in data management, in this case.
As clinical research can be unpredictable, it’s helpful to think about how the trial might progress and change, and what impact that may have on support needs in the future. Again, incorporating those needs into the selection process can reduce the risk of needing to find a new partner later in the research process.
Keep control of your budget and resources: communicate clearly
With limited budget, it’s important to ensure cost efficiency and stay in control of the clinical trial’s finances. A good FSP contract supports this. While you may face unforeseen costs in a full-service arrangement, FSP is much more tailored to your needs, as it puts the sponsor in control of the services they want, the hours budgeted and the limits.
Importantly, given the expert support offered through FSP, this approach lets you increase efficiency of operations without compromising on quality. Depending on how the contract is structured, the sponsor can adjust the support needed as the trial progresses, accounting for any changes while maintaining standards. For example, with Siron Clinical’s FSP model, you decide what support you need and when, and you pay for what you get, helping you forecast and manage your budget.
To maximize this benefit, ensure the contract is tailored to the needs of the trial and the company, incorporating enough flexibility to scale the support up or down as the research progresses. Communication is a key factor in maintaining control of budget and resources: by having regular contact with the CRO, you can stay on track and ensure they are ready to adjust the service when you need to.
Mitigate risk: work with compliance experts and maintain oversight
Clinical trial regulations require sponsors to retain ultimate oversight of the trial conduct and compliance, regardless of who is carrying out the activities on a functional basis. Although a good governance structure facilitates this in full-service arrangements, sponsors have less insight into the day-to-day operations and may therefore deal with additional compliance risks.
With an FSP model, sponsors retain total control and therefore have clear oversight. They determine what support they need and when, and they have ownership and control of the trial data. Meanwhile, since FSP contracts are often made with CROs that have cross-functional expertise, sponsors can access and benefit from their partner’s compliance knowledge and experience, further mitigating risk.
To maximize the potential of FSP to mitigate risk for your clinical trial, it’s helpful to consider potential risks from the beginning of the partnership. By incorporating risk into your requirements, you can enhance oversight and ensure compliance throughout the trial. This also enables you to work with a partner that has expertise in regulation and compliance in addition to the functional expertise you need.
The future of clinical research is flexible
At Siron Clinical, we’re seeing an increasing number of trials run on an FSP-basis, with growing demand for flexibility. Given the benefits FSP can offer – including enhanced expertise, efficiency, and control – we expect this trend to continue. For biotechs and pharma companies, it will be increasingly important to choose the right CRO for FSP services, to maximize the benefits of this model and get their intervention to patients faster.
At Siron Clinical, we know that clinical trials aren’t always predictable. With our Customizable FSP model, we provide specialist expertise and fulfill specific tasks and functions you need at every stage of your clinical trial. Find out more here.
https://sironclinical.com/services/customizable-functional-service-provider-fsp/
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