The costs of drug development have been estimated to range from US$43 million all the way up to US$2.9 billion. One Phase III trial alone is expected to cost pharmaceutical sponsors nearly US$19 million. Considering the enormous financial implications and investments associated with running a clinical trial, the industry is constantly seeking innovative solutions to streamline processes and optimize resources for high-quality results in a timely and cost-effective manner. One such solution adopted by many pharmaceutical and biotechnological companies is the Functional Service Provider (FSP) model offered by an increasing number of contract research organizations (CROs) today. In this article, we will explore the concept of FSP, compare key features to those of other strategic resourcing models, and examine the impact of FSP on the clinical research industry.  

 

Overview of the Functional Service Provider (FSP) Model 

The FSP model enables sponsors to outsource specific functional components of a clinical trial to an external partner while still maintaining their control over the data and overall process. When collaborating with experienced FSP CROs like TFS HealthScience, pharmaceutical companies gain access to a more flexible resourcing model that allows them to maintain better data oversight.  

 

Key Considerations When Selecting an FSP Partner 

To select an ideal FSP partner tailored to their specific objectives, sponsors must carefully consider many critical factors. Most notably, the FSP must understand their needs and employ a customer-focused approach in their service offerings. Additional considerations include reviewing the CRO’s clinical trial experience and track record, whether they can adapt to changes in the sponsor’s needs, as well as how effectively they can send support personnel where and when they’re needed. The quality of training and onboarding provided to talent are also important to factor into the selection process. Ideally, the right FSP partner should have previously delivered similar projects successfully, on time, and on budget.  

 

Evolution of the Functional Service Provider (FSP) Model in Clinical Research 

The FSP model has been utilized in the clinical research industry for over two decades, initially serving to assist with discrete tasks in clinical operations and data management. However, today’s models are increasingly offering features customized to meet sponsors’ needs to adapt to changes in outsourcing patterns. Between 2018 and 2021, the popularity of the FSP model increased considerably, with its utilization going from 28% to 40%.

FSP CROs are becoming an increasingly popular choice among sponsors for several reasons, including the following:  

• Potential for significant cost savings and improved efficiency 
• Access to a flexible resourcing model that enables better control over data 
• Access to talent that is not typically available 
• Enhanced opportunities to focus on technological innovation 
• Greater ability to maintain strong site relationships 

In the mid-2000s, interest in FSPs spiked when sponsors realized the value of resource flexibility. However, at the time, many trial companies and CROs were not fully equipped to establish successful FSP partnerships, resulting in the industry shifting back to the full-service outsourcing model. Since then, FSP models have changed to offer unit-based pricing options, greater administrative oversight, and increasing use of remote teams. As a result, today’s sponsors have access to a range of outsourcing options ranging from full-service to FSP models and a hybrid of both.  

 

Comparing FSP Model to Other Strategic Resourcing Options 

In addition to the FSP model, there are several other strategic resourcing models utilized in clinical research, which we provide an overview of in the table below. Each model has its pros and cons, but the FSP model stands out for its flexibility, scalability, and cost-effectiveness. 

Outsourcing Model	Pros	Cons
Functional Resourcing (FSP)	Single-function outsourcing provided scale for a dedicated team  Familiarity/team continuity improves quality and consistency  Client retains strategic control	System island limits innovation potential  Generalist approach may not fit for clients who need specialist input
Full-Service Outsourcing (FSO)	Full-service project/compound specific model  Covers all facets of clinical trial execution	Often lower-level experience leads to increased turnover  Resources often split across with multiple clients
Insourcing or Staffing	Increase scale without ceding control  Retention of systems assures continuity	Continued management oversight burden  Keeping systems/processes limits new thinking/improvement
Business Process Outsourcing (BPO)	Opportunity to leverage expertise for improvement  Immediate cost benefits	Narrow scope limits “big picture” perspective on work  Retaining control of resource planning puts delivery at risk
Capacity Management	Ability to quickly add scale through resources  Limited commitment ensures flexibility	No visibility/access to new thinking  Continued management oversight burden
Transformational Functional	Scale and system integration enhance productivity  Potential to integrate and gain efficiencies across functions	Larger upfront design requirement than some models
Hybrid	Opportunity to merge models and functions to optimize gains  Significant reduction in cost, oversight through integration	Larger upfront design requirement than some models  Larger commitment reduces flexibility and potential risk

Source: Birks (2011); KPS Life (2021)

 

Advantages of Enlisting Functional Service Providers (FSPs) in Clinical Research 

FSPs offer a range of advantages that make them an attractive option for pharmaceutical companies. They can help sponsors enhance productivity, enabling up to 30% more work to be done for the same cost. Enabling the help of FSPs also streamlines costs by outsourcing non-core activities from the sponsor to the service provider, which offers budget predictability and reduces infrastructure costs. Other financial advantages offered by this model is the lower risk of change order due to set costs, which helps simplify forecasting. FSPs also accelerate timelines while maintaining existing SOPs and systems, improve market access, and provide peace of mind due to quality management oversight and pricing predictability. Furthermore, because FSP CROs provide dedicated teams for projects, sponsors benefit from lower rates of turnover and better team continuity.  

Unlike many other outsourcing models, FSPs enable long-term relationships that develop greater efficiencies over time and provide a single functional service to a sponsor, often across multiple programs, to maximize resource utilization. They also offer increased control and oversight over deliverables, reduced risk of underutilization, and cost-effective contract rates. Lastly, by partnering with an FSP CRO like TFS, sponsors can unload significant operational burdens by transferring over the responsibility of certain time-consuming aspects of running clinical trials. These can include training and onboarding, performance management, staff oversight, and administrative tasks. 

 

TFS CRO’s Strategic Resourcing Solutions Unit Offers Functional Services (FSP) 

Founded in Lund, Sweden, in 1996, TFS was the first CRO in Europe to offer Functional Services (FSP). Since then, they have become a leading company for client-centric FSP solutions with their teams based in 17 countries, which enables them to support both international and local sponsors. This means that no matter where a trial is taking place, TFS HealthScience can provide the necessary support and expertise. TFS offers a wide suite of services, including expertise in project management, clinical and medical monitoring, pharmacovigilance, strategic resourcing, and more.  

The company is a full-service, global, strategic CRO partner for clinical trial sponsors. The CRO’s FSP team also maintains an up-to-date understanding of today’s clinical trial landscape, which is why they successfully leverage various technology solutions to meet deliverables effectively. This includes their EDC partnerships with cutting-edge tools and software like Medidata Rave, TrialMaster, and Trial Online, as well as other solutions to ensure streamlined online project tracking. By leveraging modern technology and expertise in project management, TFS can deliver efficient, cost-effective solutions that ensure the success of their clients’ clinical studies. 

 

Conclusion 

In conclusion, FSPs in clinical research are an innovative solution to streamline processes, optimize resources, and manage costs effectively. With the unique ability to provide dedicated teams, retain data oversight, and adapt to evolving needs, FSP CROs are revolutionizing the way pharmaceutical and biotechnological companies conduct research. By collaborating with an experienced FSP such as TFS, sponsors can focus more on their core functions, while delegating certain aspects of their clinical trial operations to capable CROs. 

 

About TFS HealthScience CRO 

At TFS HealthScience, our global full-service CRO is more than a service provider; we are a trusted partner in the drug development journey for biotechnology and pharmaceutical companies. In partnership with our customers, we build solution-driven teams working toward a healthier future. Having provided FSP solutions for over 25 years, we understand the importance of providing affordable and scalable services while maintaining a partnership with synergistic value.  

Visit our Functional Services (FSP) page to learn more about the several resourcing models we offer for sponsors looking to benefit from our FSP services, or connect with a TFS representative today!