Workforce turnover has always been a challenge for Clinical Research Organizations (CROs), but the problem has accelerated during the last decade. 

If you’ve ever taken an Uber, stayed at an AirBnB or hired a TaskRabbit, you are participating in the gig economy. The gig economy is projected to grow to $455B by the end of 2023, more than doubling its gross volume in the last five years. Historically dominated by the transportation and waged sectors, there has been a notable increase in demand for highly skilled, specialized workers. As a result, executives are beginning to understand the importance of the gig economy when it comes to finding skilled employees in a tight labor market.

Even the pharmaceutical/biotech industry – which requires employees to be highly trained and educated in their field of expertise – is beginning to adopt this “gig economy” business model for support in clinical trials. For decades, most major pharmaceutical and biotech companies relied heavily on full-service outsourcing to bring new drugs and therapeutics to market. This business model used contract research organizations (CROs) to complete the full range of clinical trial activities.

While the full-service model is still popular, the last five years have seen a notable shift in the way that pharmaceutical and biotech companies allocate their resources and delegate clinical trial responsibilities. More and more, Biotech and Pharma companies are enlisting the help of a functional service provider (FSP) instead of, or in addition to, their full-service CRO. One such provider, Harbor Clinical, has redefined the FSP model to accommodate demand from both sponsor companies and employees for a more flexible work environment. 

The Redefined FSP approach provides experienced professionals for shorter-term engagements as needed and/or for part-time hours. This  allows companies to engage specific experts –– like medical writers, clinical monitors, or biostatisticians –– exactly when and where they need them. Likewise, it provides the flexibility employees are seeking.

Considering the complexity of modern drug development pipelines and the razor-thin margin for error, it’s no wonder many industry experts predict the FSP model is the future of clinical trial execution. In fact, “research shows that large biopharma companies’ use of FSP is growing at more than 13% annually. 

The Advantages of Functional Service Providers (FSP) vs. Full Service Outsourcing 

A 2019 study by life sciences consulting firm, the Avoca Group, highlighted the various benefits of employing an FSP, including “increased quality, decreased costs, strategic control, and greater brand recognition.”

Let’s take a closer look at the advantages of an FSP structure:

1) Decreased costs

Full-service outsourcing isn’t cheap and it is not always the most efficient use of resources. Enlisting an FSP lowers your costs by reducing employee redundancies. It provides you the freedom to pick and choose the experts you need to fulfill very specific tasks. And, since FSP employees act as an extension of your team, you can train them to use your in-house systems and established processes. 

2) Increased flexibility

Many sponsors find the traditional full-service outsourcing model somewhat antiquated and inflexible. Once a clinical trial or study begins, it can be nearly impossible to make changes until the research is complete and it may be too late. 

Conversely, FSPs allow sponsors to scale their teams as needed throughout the trial and can quickly pivot at any stage.

As this article from IQVIA notes, “clinical FSP models provide the flexibility to rapidly ramp-up…clinical teams across the globe, and easily adjust headcount in response to changes across studies or a portfolio of studies –– whether that requires shutting down a program or building additional capacity due to incoming assets or an acquisition.”

3) Improved Oversight and Control

We’ve touched on this point already, but it can’t be overemphasized –– partnering with an FSP puts you in the driver’s seat. 

Full-service CROs use their own systems and standard operating procedures, whereas FSPs learn and implement the sponsor’s. Moreover, the involvement of the FSP in every aspect of trial design and execution ensures accountability.

4) Specialized expertise

Drug development volume increased by 30% between 2020 and 2022. This trend is expected to continue, especially with new technologies like gene editing, artificial intelligence, and big data playing greater roles in the drug and therapeutic research and development process. 

As studies become increasingly complex, so too does the need for niche expertise. The FSP model provides access to highly specialized talent to complement the sponsors’ in-house strengths.

5) Lasting business relationships

Perhaps most surprising is the role an FSP can play in solidifying long-term business relationships. Since the FSP acts as an extension of the sponsor’s team, they’re familiar with the team’s expectations. This transparency and commitment to true partnership build trust and ultimately, lasting satisfaction.

Conclusion: FSPs – The Future is Functional, Flexible, and Fractional

No one knows what the future holds, but a growing body of evidence suggests the shift toward implementing FSPs isn’t stopping anytime soon. With Harbor Clinical’s redefined FSP model, the advantages are enhanced with additional flexibility for employees and increased quality and cost savings for sponsors.

A Frost & Sullivan Report found that “the Global Clinical Research Organization (CRO) market is expected to grow $71.7 billion in 2024. Within that growth, Functional Service Provider (FSP) relationships are expected to grow at a CAGR of 5-6%. Sponsor organizations turn to the FSP model as an outsourcing strategy for multiple reasons. Efficiency, consistency, scalability, global reach, and cost reduction generally top that list.”

For the same benefits both employers and employees credit for the rise in the gig economy – increased control and flexibility and decreased time and money – the use of a flexible Functional Service Provider is becoming increasingly popular in the biopharma industry. By providing immediate access to part-time or full-time subject matter experts that become an extension of your in-house team, Harbor Clinical supports clinical trial needs; increases the sponsor’s level of control, oversight and scalability; and helps reduce risk, redundancy, and overall costs. 

Reach out today to see how Harbor Clinical can help support your clinical trial needs. [email protected].