Governance, data and talent: what to plan before moving to a mixed FSP/FSO model

As clinical development becomes increasingly complex, sponsors face growing pressure to accelerate timelines, manage expanding pipelines, access specialized expertise and scale resources efficiently, all while maintaining visibility and control over critical development activities. To meet these challenges, many sponsors are moving beyond traditional outsourcing approaches and adopting mixed functional service provider (FSP) partnership/full-service outsourcing (FSO) models. By combining the embedded talent, flexibility, and control of FSP solutions with the therapeutic depth and end-to-end delivery capabilities of FSO arrangements, mixed FSP/FSO models offer the flexibility to tailor support based on specific organizational needs, therapeutic areas and development priorities.

However, transitioning to a mixed FSP/FSO model is more than adding resources or outsourcing additional work. Success requires thoughtful decisions about which functions should remain in-house, which may benefit from dedicated FSP support, and which are best delivered through an FSO arrangement. Based on extensive experience integrating FSP services into new and existing FSO arrangements, PPD™ Functional Service Partnership (FSP) solutions experts have identified several key considerations for organizations to build a more efficient, scalable and adaptable clinical development model.

Start with governance: What requires closer sponsor oversight?

One of the biggest misconceptions about mixed FSP/FSO models is that they are simply a blend of FSP and FSO resources. In practice, they are a deliberate allocation of responsibilities designed to balance agility, control, and expertise.

Before determining what to outsource, sponsors should identify their internal priorities, current capabilities and capability gaps. They should also consider which functions require greater strategic control or sponsor-led oversight.

Factors to consider include:

• Therapeutic pipelines: A bespoke mixed FSP/FSO model enables a sponsor to maintain consistency and continuity across their portfolio.
• Volume demands: Changing levels of functional support are essential to accommodate dynamic needs over time.
• Strategic programs: Long-term strategic control is another key consideration in conceptualizing the transition to a mixed FSP/FSO outsourcing model.

PPD FSP solutions experts point out that it’s critical to have a well-defined strategy that identifies which study functions to retain internally and which to outsource to CRO partners. The goal is identifying where direct oversight creates the greatest value and where external expertise enhances execution without compromising control.

Evaluate your data and operational ecosystem

Once ownership is defined, organizations should assess how work and information move across teams. A mixed FSP/FSO model often involves multiple stakeholders, systems and processes and without careful planning this complexity may create operational silos, reduce visibility and introduce unnecessary risk.

Sponsors should ask themselves:

• Which sponsor, CRO or shared systems and SOPs will be used?
• Which system and processes will be used?
• Who needs access to each platform or source of information?
• Where will data move between teams or providers
• How will processes, KPIs and reporting cadence be standardized?

Technology and data interoperability are among the most common challenges when blending sponsor and CRO operations. Systems ownership, data flow, reporting expectations, access requirements and workflow dependencies should all be mapped before implementing a mixed FSP/FSO model.

Beyond establishing consistency and interoperability at the time of transition, staying open to innovation rather than anticipating long-term stagnancy is a cornerstone of a strong mixed FSP/FSO model. Clinical trial technologies evolve rapidly, so change management efforts should also foster ongoing collaboration that drives adoption of advanced technologies and platforms.

Assess talent needs across the portfolio

Many decisions about mixed FSP/FSO models ultimately come down to resourcing. Organizations often pursue mixed FSP/FSO delivery approaches because they need access to specialized expertise, scalability and continuity that may be difficult to build internally. Therefore, a comprehensive talent assessment should evaluate both current and future needs.

Current capability questions to consider may include:

• Is there sufficient in-house expertise?
• Are specialized skills difficult to recruit?
• Do current resources have the capacity to support anticipated demand?

Future scalability questions that also should be considered include:

• Will pipeline growth require rapid expansion?
• Are new therapeutic areas anticipated?
• Will studies expand into new geographies?
• Will there be increased study complexity?

According to PPD FSP solutions experts, mixed FSP/FSO models are often deployed to address these challenges by enabling sponsors to access specialized expertise where and when it is needed while maintaining flexibility as priorities evolve.

Responsibilities may be allocated in several ways:

• Retained in-house: Functions the sponsor determines should continue to be performed internally.
• Supported through FSP partnerships: Specific functions or roles requiring additional capacity, capabilities or support across studies or programs.
• Delivered through FSO arrangements: Study- or protocol-level activities managed end to end by a CRO partner.

When deciding which functions to retain internally, sponsors should consider their current capabilities, capability gaps, current and future pain points, anticipated trajectory and strategic priorities. By evaluating each function through the lens of strategic importance, expertise requirements, scalability needs and operational complexity, sponsors can create a bespoke outsourcing model that supports both efficiency and control.

The advantage of building for change

PPD FSP solutions experts find that flexibility is one of the significant benefits of a mixed FSP/FSO model. Resource levels and functional needs can change over time as programs scale or expand. Organizations may need to expand into new therapeutic areas, enter new regions, scale rapidly or respond to unexpected capability gaps.

A well-designed mixed FSP/FSO model provides the flexibility to evolve as those needs change while maintaining continuity and operational efficiency. This flexibility allows sponsors to scale access to talent, add functional or therapeutic expertise and adjust support as needs change.

Build the right balance of agility, control and expertise

The right mix of FSP and FSO support will depend on the sponsor, the work being delivered and the needs of the study or portfolio. The most effective mixed FSP/FSO model strategies are built around a sponsor’s unique combination of governance requirements, operational priorities, talent needs and growth objectives. Clearly defining which responsibilities remain in-house and which are delivered through FSP or FSO support creates a strong foundation for the transition.

PPD FSP solutions help sponsors strengthen existing outsourcing arrangements and successfully transition to customized mixed FSP/FSO models. Through deep functional expertise, global talent resources and extensive experience integrating with both new and established FSO partnerships, we create tailored outsourcing strategies that maximize efficiency, maintain control where it matters most and build a more resilient clinical development ecosystem.

Meet your timelines with PPD FSP solutions

PPD FSP solutions help biotech and biopharmaceutical companies meet their timelines by delivering the best of the best: hard-to-find, top-tier staff with a proven track record of reliably delivering clinical development and post-marketing services.

Because you can’t always predict—or find and retain—the staff and services you need, our experts provide outstanding therapeutic and functional expertise, uniquely positioning us to deliver the right experience and knowledge to fill immediate resource and capability gaps.

To ensure projects launch on time and stay on budget, we employ dedicated transition and implementation roles and processes for swift deployment of staff and services, transparent communications, and proactive problem-solving.

With more than 30 years of support for clinical and marketed products, we know what it takes to solve your specific challenges. Whether you need to fill small service gaps or outsource multiple functions across a portfolio, we deliver customized solutions tailored to your needs, providing resource flexibility, reliability and continuity.