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The increasing adoption of the FSP model is fueling substantial market growth. Over the past two years, biopharma and biotech leaders reported 41% greater use of FSPs compared to 29% growth for the full-service outsourcing (FSO) market.1 Meanwhile, FSP growth is projected to continue at a compound annual growth rate of more than 8.5% from 2023 to 2029.2
However, many of the same aspects that make up the appeal of the FSP model—including its speed, flexibility, increase in data control and transparency, breadth and depth of capabilities, and partnership-oriented approach—also mean that careful planning, collaboration, and expertise are needed to pave the way to maximize the model’s benefits. With that in mind, here are five elements that are critical to consider when implementing new FSP partnerships.
1. Choosing the right partner
At times, your needs for an FSP partner may be exceptionally specialized within a particular function or therapeutic area (e.g., a rare disease). Or your needs may be broad, involving multiple functions in multiple regions worldwide that may involve hundreds—perhaps thousands—of professionals. It’s important to find an FSP partner with the capacity and global footprint to meet your immediate needs—and your pressing timelines. FSP partners with a large internal talent pool spanning functional areas, therapeutic areas, and the globe—including emerging markets—are especially well positioned to rapidly deploy large numbers of qualified employees to new FSP engagements when and where you need them.
At the same time, because you can’t always predict your future clinical development needs, a partner with well-established global operations that offer a broad and deep portfolio of experts and services in strategic locations ensures you have high-quality resources available to meet your evolving requirements. For example, you may decide to expand a trial to an emerging region to tap research sites with lower clinical trial activity and access to naive patient populations. FSP partners with a large global footprint and specialized therapeutic experience bring the necessary expertise in navigating different regulatory landscapes to ensure compliance with local rules and regulations.
It is important to also recognize that an FSP partnership goes well beyond a mere staffing arrangement or a substitute for in-house resources. Instead, the FSP relationship should be seen as an extension of the client, aligned with the client’s culture and aspirations. The most successful FSP relationships are forged when both partners value the collaborative aspects of the FSP model.
When working with an FSP partner, fostering a sense of ownership and empowerment among the FSP team members is critical to maximize the value of the relationship. With this approach, staff become more than just resources; they become an integral partner of the team, actively contributing their knowledge and insights, and bringing unique perspectives to the table to drive innovation.
2. Finding the right way
Once you have found an FSP partner, the next step is to work together to find the right arrangement. An FSP partnership can play a vital role in assessing the feasibility of different options to achieve your goals with the best investment returns.
Part of the appeal of an FSP relationship is that it offers the flexibility to either embed the FSP partner’s staff within your workforce or the FSP partner can take your work in-house using their staff, innovations, and technologies—or some combination. You also can consider leveraging a customizable mix of systems, processes, oversight, and reporting structures—yours or the FSP partners—to best meet your situation. As well, an FSP partner’s pricing and contract structures can vary from full-time equivalent (FTE), unit-based, outputs-based, time and materials, to hybrid models. For example, in divested areas, you might negotiate with the FSP partner for a flexible FTE model based on the level of activity or workload, ensuring efficient resource allocation and operational efficiency.
And because clinical trials often require adjustments in staffing levels and resources based on the progression of the study, an FSP partner also should have the capability to ramp up or down to accommodate fluctuating workloads, ensuring seamless support while avoiding waste.
To help scope your FSP work, especially for larger engagements, comprehensive data and capacity management planning is needed to create realistic assumptions for resource demands and cost projections. This entails careful coordination between finance, clinical, and operational teams to ensure forecasts align with clinical and operational realities. Proactively anticipating future needs – as well as identifying and mitigating potential risks – also helps avoid delays to keep projects on time and on budget.
3. Selecting the right resources
In a global market where the demand for clinical development professionals continues to outpace supply, it is critical to work with an FSP partner that has the talent and/or services you need in your geographies of interest. This may include functional, operational, technical, and therapeutic specialists across all phases and therapeutic areas at all levels. To that end, sourcing staff from an FSP partner’s own internal talent pool that already is vetted and trained specifically in FSP processes allows resources to be mobilized quickly to deliver on impending timelines. By placing individuals who are already well-versed in working within the FSP framework, the FSP partner can offer a seamless transition and ensure that the personnel assigned to the engagement are fully equipped with the necessary skills and understanding of FSP processes, resulting in a more successful collaboration.
To maintain a pool of top-tier professionals in a hyper-competitive talent market, an FSP partner also needs a mature global recruitment engine that is continually engaging candidates. Hiring hard-to-find talent—including passive candidates not actively job searching—often takes a combination of active recruiter-to-candidate outreach. This may involve a wide range of methods from combing through traditional platforms like LinkedIn and Indeed to using programmatic solutions to streamline candidate targeting, ad distribution and screening. A mature employee referral program is also effective for connecting with high-caliber candidates not currently on the open job market.
The skill and experience of dedicated FSP recruiters is also critical to successful FSP partnerships. The best recruiters have access to the latest methodologies, technologies, databases, and tools. But more than that, they intuitively know how to identify top talent that aligns with a client’s phenotype and specific needs. After all, the success of a recruitment effort extends beyond finding qualified individuals; it also depends on the quality of the match between the recruited candidate and the client’s organizational culture and team dynamics. An FSP partner should collaborate closely with clients to understand their needs, culture, and desired talent profile to develop a bespoke recruiting strategy that ensures the selected professionals will integrate into their teams.
4. Getting off to the right start
Many FSP engagements require a significant number of resources within specific timeframes, often spanning multiple locations, perhaps across the globe. To ensure a seamless and efficient collaboration while alleviating any additional burden on your end, your FSP partner must have dedicated roles and processes in place to swiftly identify and deploy staff. It is also important to set realistic timeframes and maintain transparent and frequent communication throughout the talent deployment process.
To initiate the relationship, the FSP partner must orchestrate many different activities that require coordination and planning aligned to your goals. For example, documentation such as an implementation plan, operational handbook, RACI (Responsible, Accountable, Consulted, Informed) task matrix, and onboarding checklists should be established. A seasoned implementation lead at the FSP partner should oversee the coordination of interactions between different teams and departments, ensuring the seamless execution of project objectives and taking responsibility for key performance indicators (KPIs), financial oversight, the development and rollout of governance and operational handbooks, and the coordination of IT, equipment, and system integration.
Furthermore, because it is common for drug developers to want FSP professionals to adhere to their own standard operating procedures (SOPs) and systems, synchronization between client training protocols and the FSP partner’s internal resource management is critical.
5. Nurturing the right environment for sustained success
Building a long-term collaborative partnership requires open and transparent communication that promotes mutual understanding, trust, and a shared commitment to common goals. This means fostering an environment where all parties feel comfortable having honest conversations, addressing challenges head on, and seeking solutions together. By cultivating an atmosphere of open communication, the partnership can effectively address and resolve challenges before they escalate. Regular check-ins, status updates, and feedback sessions are critical, as is swift identification of changing needs and the integration of new staff and services as needed to avoid delays and put timelines at risk.
| Key questions to ask a potential FSP partner |
|---|
| Do you have the operational structure, capabilities, and geographic footprint to scale resources when and where we need them? |
| Will you primarily staff my engagement with internal staff or rely on external hires? |
| Can you provide examples of innovative recruitment methods you use to attract top talent? |
| What percentage of your hires comes from referrals? |
| What are your talent deployment processes—and do you have dedicated roles managing them—to ensure a fast and efficient startup? |
| Does your staff have the expertise/experience to apply the latest insights, approaches, and best practices to optimize my clinical trial? |
| How do you ensure FSP candidates will be a good cultural fit with my teams? |
| How will you continue to develop the FSP staff you assign to my engagement? |
| What are your best practices to build an ongoing collaborative partnership? |
| Will you include a dedicated point person to provide oversight, strategic planning, and relationship coordination? |
To help facilitate a collaborative partnership, the FSP relationship should include a single point of contact for the partnership to provide oversight and strategic planning. This individual serves as the central liaison, ensuring smooth communication and coordination between all parties involved. By having a dedicated point person, the partnership can streamline processes, enhance efficiency, and ensure client interests are prioritized. Additionally, this role can work closely with the client to understand resourcing forecasts and manage capacity, allowing for better predictions of budgets and resource allocation.
Ongoing staff development is also key to retaining staff and enriching the relationship. Even for those FSP employees working within client systems and SOPs, there typically are opportunities for upskilling and/or reskilling, increasing technical competencies and supporting their personal and professional growth. In addition to formal group training, this may include peer support, coaching and mentoring, and graduated study assignments to help staff excel in their roles, resulting in improved productivity and enhanced outcomes for the partnership.
And because soft skills are as important as technical skills, helping FSP staff improve their ability to communicate, negotiate, and handle conflicts can improve collaboration and the development of strong relationships that lead to successful partnerships.
Conclusion
Successful implementation of functional service partnerships requires diligent planning, collaboration, and expertise. By choosing the right partner, defining the right approach, selecting the right resources, starting off on the right foot, and nurturing a collaborative environment, organizations can unlock the full potential of FSP partnerships to reach their goals—even on aggressive timelines.
Sam Hadfield
Beverly Yamashita
Cami Stewart-Myers
References
- PPD. The Pulse Report 2023. Accessed January 15, 2024. https://www.ppd.com/pharmaceuticals-research-and-development/
- Markets & Markets. Functional service provider (FSP) services market – global forecast to 2029.
Authors
Samantha Hadfield, executive director, project management; Cami Stewart-Myers, associate director, project oversight; and Beverly Yamashita, associate director, project oversight are all with PPD FSP solutions, part of the PPD clinical research business of Thermo Fisher Scientific.
Filed Under: clinical trials, Drug Discovery, Regulatory affairs
