By Jennifer Maffia, Owner of Advanced Recruiting Partners 

In clinical research, we talk about “outsourcing” constantly. But one thing I’ve noticed over the years is that the word can become an umbrella for very different ways of getting work done. 

Functional Service Provider (FSP) models are a good example. 

Yes, FSP technically falls within the outsourcing landscape. But treating FSP and traditional full-service outsourcing as interchangeable misses an important distinction. In a typical FSP arrangement, the sponsor retains more direct control while dedicated external professionals support specific functions and often operate within the sponsor’s systems, processes, and ways of working. With full-service outsourcing, a CRO generally assumes responsibility for end-to-end execution of a study using its own operational infrastructure.  

That difference matters, particularly as biotech companies look for ways to scale without necessarily building every capability internally. 

Outsourcing the Study vs. Extending the Team 

With a traditional full-service CRO model, a sponsor can delegate much of a clinical trial’s execution to an external partner. The CRO provides the people, processes, systems, and project management necessary to carry the study forward, while the sponsor maintains oversight. 

For the right organization and program, that can make tremendous sense. A smaller biotech may not have the infrastructure or internal bandwidth to execute a complex study independently. Full-service outsourcing gives that company access to established capabilities without having to build an entire clinical operations organization itself.  

FSP approaches the problem differently. 

Rather than outsourcing an entire study, a company can bring in external resources for specific functions such as clinical monitoring, data management, biostatistics, medical writing, pharmacovigilance, or regulatory support. Those professionals can work much more like an extension of the sponsor’s existing team.  

The sponsor gains capacity and expertise while retaining greater control over how that talent is deployed. 

From a workforce perspective, that distinction is significant. 

Why FSP Is Appealing to Growing Biotechs 

I spend a lot of time speaking with both hiring leaders and professionals across life sciences, and one challenge comes up again and again: organizations need expertise, but their talent needs rarely grow in a perfectly predictable line. 

A biotech may suddenly need additional clinical monitoring capacity. A pipeline milestone can create demand for specialized regulatory expertise. A growing portfolio might strain an existing biometrics team. 

The traditional answer was often to hire permanent employees or hand more responsibility to a CRO. FSP creates another option. 

Specific functions can be scaled as needs change, while the sponsor maintains oversight and preserves more institutional knowledge internally. Modern FSP arrangements range from staff augmentation to managed and performance-driven models, making the category considerably broader than it once was.  

But there is an important caveat: more control also means more responsibility. 

FSP Isn’t Automatically the Better Model 

I don’t believe organizations should approach this conversation by asking which model is “best.” 

They should ask which model fits. 

An FSP strategy works particularly well when an organization knows what it wants to own internally and has the leadership and infrastructure necessary to manage integrated resources effectively. 

If you retain strategic and operational control, someone still has to provide that direction. Governance matters. Communication matters. Processes matter. The relationship between internal employees and external professionals matters. 

Full-service outsourcing may be the better choice when a sponsor needs broader infrastructure and wants a partner to assume greater responsibility for execution. 

And increasingly, the answer may be both. 

Hybrid models combine elements of FSP and full-service outsourcing, allowing companies to use different approaches depending on the study, function, development stage, and internal capabilities.  

That reflects something those of us in talent already know: workforce strategy rarely fits neatly into one box. 

Start With What You Want to Own 

Before deciding how to resource a program, I encourage leaders to ask a different set of questions. 

What expertise do we already have? Where are our genuine capacity gaps? Which capabilities are strategically important for us to retain internally? Which needs are temporary? Where do we need specialized expertise quickly? And, perhaps most importantly, do we have the internal leadership to successfully manage the model we’re considering? 

Those questions shift the conversation from “How much can we outsource?” to “What kind of organization are we trying to build?” 

That is a much more useful conversation. 

A company that wants to develop strong internal clinical operations capabilities may make very different decisions than one that intends to remain lean and rely heavily on external partners. Neither approach is inherently right or wrong. 

The talent strategy should support the business strategy. 

The Right People, in the Right Structure 

There is another reason I believe FSP deserves attention from talent leaders: hiring isn’t only about finding qualified people. 

It is about placing expertise in the structure where it can have the greatest impact. 

A highly experienced clinical research professional can still struggle when expectations, authority, processes, and communication are unclear. Conversely, external professionals who are properly integrated into a sponsor organization can bring tremendous value, continuity, and specialized expertise. 

That is why conversations about FSP shouldn’t happen solely within procurement or operations. Talent leaders belong at the table. 

Whether an organization chooses permanent hiring, FSP, full-service outsourcing, or some combination of the three, we are ultimately talking about people performing highly specialized work in an industry where execution matters enormously. 

The goal shouldn’t be to outsource as much as possible or keep as much as possible in-house. 

The goal is to build the right combination of expertise, flexibility, accountability, and continuity for the work ahead. 

So before asking who should perform the work, start with the more important question: 

What do we want our organization to own? 

About Jennifer Maffia 
With over 20 years of experience in clinical staffing, Jennifer Maffia connects pharmaceutical, biotech, and life sciences companies with top-tier clinical talent. She is known for building lasting client relationships, supporting tenured recruiters, and driving impactful hiring strategies. Through industry partnerships and active board involvement, Jennifer remains committed to advancing the life sciences field and improving patient outcomes.