VP Operational Delivery, PPD FSP Solutions, part of the PPD clinical research business of Thermo Fisher Scientific

Samantha Hadfield

As sponsors face mounting pressure to accelerate timelines while managing costs and expanding portfolio complexity, many are moving past the binary choice between functional service provider (FSP) and full-service outsourcing (FSO) models. 

spoke with Samantha Hadfield, VP Operational Delivery, PPD FSP Solutions, part of the PPD clinical research business of Thermo Fisher Scientific, about how mixed FSP/FSO strategies are reshaping clinical development operations. Hadfield discusses common triggers for adopting blended models, governance structures that support accountability across outsourcing relationships, and the internal capabilities sponsors need before pursuing this approach.

PharmTech: How Do You Define FSP, FSO, and Mixed FSP/FSO Models, and What Distinguishes Each Approach?

 A FSP model provides dedicated resources to support specific clinical trial functions, such as clinical operations, pharmacovigilance (PV), or medical writing, as a few examples. These resources operate as an extension of the sponsor’s team, working within established processes, systems, and governance structures to deliver deeper functional expertise while supporting team continuity and visibility into day-to-day activities, aligned with the sponsor’s goals and ways of working.

A FSO model covers a broader scope of work, potentially including an entire study or program, supported by a CRO [contract research organization] that manages delivery across functions. This model provides sponsors with access to broader capabilities and operational scalability while shifting greater responsibility for execution, resource management, and delivery outcomes to the CRO.

A mixed FSP/FSO model combines FSP and FSO approaches to create a tailored outsourcing strategy. Sponsors may integrate FSP and FSO solutions from the outset or add targeted FSP capabilities to an existing FSO partnership as needs evolve. This flexible model can support individual studies, portfolios, or enterprise-wide programs, enabling organizations to scale resources, expand into new regions or therapeutic areas, retain oversight of strategic functions and data, preserve continuity across programs, and balance flexibility with operational execution throughout clinical development.

What Are the Most Common Trigger Events That Push Sponsors to Adopt a Mixed FSO/FSP Model?

The most common trigger is a change in portfolio needs. As sponsors expand their pipelines, enter new therapeutic areas, or integrate assets through M&A, they often need specialized capabilities quickly without the time or investment required to build them internally. Shifting clinical trial volume and increasing study complexity are also common catalysts, as is the need for greater access to data and real-time transparency into clinical trial outcomes to enable faster, more data-led decisions. A 

 found that 84% of sponsors say accelerating development timelines is their top organizational priority, while 72% cite managing costs.

Balancing these competing priorities is increasingly leading sponsors to adopt mixed FSO/FSP models that allow them to retain dedicated expertise where it matters most while scaling support across broader programs and evolving portfolio needs.

As Sponsors Move Away from Treating FSO and FSP Models as a Binary Choice, What Does a Well-Designed Mixed Model Look Like in Practice?

A well-designed mixed FSP/FSO model is not a fixed operating structure, but an approach that evolves alongside a sponsor's portfolio. As programs mature, geographic footprints expand or resource demands shift, sponsors should be able to adjust how work is allocated between FSP models and FSO without disrupting delivery.

In practice, responsibilities are often assigned at the function, program, or regional level rather than through a single enterprise-wide outsourcing strategy. Sponsors may initially rely more heavily on FSO support to launch a new program and gradually transition specific functions or regions to an FSP model as demand becomes more consistent or deeper integration with internal teams is needed.

The final component is clear governance and accountability. Successful mixed FSP/FSO models require defined ownership of strategic decisions, including when a function should transition between FSO and FSP support based on changing priorities, operational requirements, or portfolio needs. Without ongoing evaluation and active management, the model can become static rather than continuing to deliver the flexibility and efficiency it was designed to provide.

What Internal Capabilities or Infrastructure Does a Sponsor Need to Have in Place Before a Mixed FSP/FSO Model Can Succeed?

The foundation for a successful mixed model is organizational alignment. Sponsors need clinical, operational, and financial teams working from the same assumptions around demand, capacity, timelines, and cost, rather than planning independently. Just as importantly, they need governance that is designed to manage both FSP and FSO relationships as parts of a single operating strategy instead of separate outsourcing models. A clear technology roadmap is also critical, including the right infrastructure and investment to enable data sharing, transparency, and connectivity across the different delivery models.

A dedicated point of accountability matters here. Without someone holding a coordinated view across both models, sponsors tend to end up managing FSP and FSO engagements as 2 separate workstreams instead of as parts of 1 operating strategy. Sponsors also need a single source of truth that provides visibility into shifting priorities, best practices, and lessons learned across programs, helping support transparency and business continuity.

The problems that surface when this foundation is missing are fairly predictable: reporting that doesn't line up between the 2 sides, unclear ownership when something falls in a gray area, and slower issue resolution because nobody's looking at the full picture. In most cases, what trips organizations up is not the mixed model itself. It is trying to run a more complex delivery structure on governance, technology, and processes that were built for managing a single outsourcing approach.

What Structures Have You Seen Work Best for Maintaining Oversight and Accountability Across a Blended Outsourcing Portfolio?

The most effective governance structures create a single operational view across both FSP and FSO models rather than treating each relationship independently. Cross-functional steering committees that include clinical operations, procurement, and finance help ensure decisions around resources; budgets and timelines remain aligned across the portfolio.

A clearly defined responsibility assignment matrix (RACI) matters more than sponsors often anticipate. Once FSP and FSO resources are both touching parts of the same program, ownership can become blurred, particularly around escalation paths and decision rights in areas where responsibilities overlap. A well-constructed RACI addresses this before it becomes a problem rather than after.

Technology is the third piece. Shared dashboards and common reporting frameworks have become standard practice among sponsors managing blended portfolios, largely out of necessity. Monitoring risk and progress across 2 outsourcing models is difficult when the underlying data lives in separate systems without shared reporting structure.

Finally, none of these elements hold together without a designated owner. The mixed models that function well have someone accountable for coordinating across both sides and adjusting the balance as priorities change, rather than allowing the portfolio to become a set of disconnected vendor relationships managed independently of one another.

What Is the Biggest Misconception Sponsors Have About Mixed FSP/FSO Models?

Many think of a mixed model simply as a way to manage multiple vendors or a binary outsourcing decision presented in a different format. In reality, a successful mixed model requires a deliberate strategy, with a clear understanding of the desired operating model, defined roles and responsibilities, and a roadmap for implementation and ongoing optimization.

Another common misconception is viewing FSP models as only a form of staff augmentation. Sponsors that approach FSP models as a transactional resource approach might miss the opportunity to gain the deeper expertise, continuity, and strategic value that these partnerships can provide. When structured around shared goals and key milestones, FSP teams can operate with a project-oriented mindset, creating greater alignment and a shared investment in outcomes across the broader delivery model.

Do You See Mixed FSP/FSO Models Becoming the Default Approach Across the Industry?

Mixed models are best suited for organizations navigating growth, increasing portfolio complexity and evolving resource requirements. As sponsors face pressure to do more with less and ambitions expand around faster decision-making, greater data transparency and more real-time approaches to clinical data review, they will increasingly need operating models that can support AI adoption while maintaining appropriate control, quality, and oversight.

Mixed FSP/FSO models can provide a customized combination of specialized expertise, resources, and technologies, allowing sponsors to leverage internal strengths while accessing targeted CRO capabilities where, when and how they are needed. This flexibility can help sponsors introduce AI-enabled ways of working while maintaining the data stewardship, governance, and oversight required to operate effectively. As clinical development becomes more global, specialized and data-driven, mixed FSP/FSO strategies will become an increasingly important part of how sponsors build adaptable, technology-enabled operating models for the long term.

PPD clinical research business of Thermo Fisher Scientific. The Pulse 2026: Global pharmaceutical R&D insights—balancing pressure and possibility. Published 2026. 

https://www.ppd.com/wp-content/uploads/2026/02/PPD-2026-The-Pulse-Survey-Data-Report.pdf

Articles

Sponsors are increasingly adopting mixed FSP/FSO outsourcing to balance speed, cost control, and rising portfolio complexity. FSP embeds dedicated functional experts within sponsor processes, while FSO delegates broader program delivery to a CRO; blended models dynamically allocate work by function, program, or region as needs evolve. Common triggers include pipeline expansion, new therapeutic areas, M&A integration, variable trial volume, and demands for real-time data transparency. Success depends on aligned cross-functional planning, integrated governance, shared reporting infrastructure, clear decision rights, and an accountable owner to continuously rebalance the model.

Samantha Hadfield, PPD, explains how mixed FSP/FSO models help sponsors balance speed, cost, and complexity in clinical trial outsourcing.