Meeting Halfway: Co-Developing Frameworks for Seamless FSO to FSP Transitions

As clinical trials grow increasingly complex, the biopharmaceutical research industry faces a number of unprecedented pressures that are shifting the way outsourcing models are deployed. Sponsors are confronting macroeconomic headwinds: increased demand to accelerate cycle times, mounting cost pressures, and intense competition for sites and their prioritization of work.

Simultaneously, technological innovation is reshaping what's possible. Advanced analytics and artificial intelligence (AI) are enabling real-time data insights, allowing sponsors to reach decisions faster and improving workforce productivity and collaboration in ways unimaginable just a few years ago.

In response to these changes, the industry is witnessing an uptake in the use of the functional-service provider (FSP) model from sponsors who may have been traditionally using the full-service outsourcing model (FSO) model in the past. The FSP model provides increased flexibility and efficiencies, while allowing sponsors to leverage both internal capabilities and external support.

Making this transition in a way that maintains both quality standards and study timelines remains critical. Here, we’ll explore the steps sponsors can take to successfully execute this transformation.

The Power of Meeting Halfway

As biopharmaceutical companies begin considering the transition from FSO to FSP models, it can often feel as if they must navigate this complex journey alone. Without guidance, many find themselves reinventing the wheel, developing solutions and strategies from scratch that others have already refined.

In contrast, clinical research organizations (CROs) bring invaluable knowledge from managing these shifts across the industry, offering sponsors a real opportunity to leverage proven approaches and lessons learned. CROs understand the importance of geographic strategy in resource planning, the delicate balance required when moving teams between models, and the critical timing considerations that can make or break a transition.

Yet too often, the industry falls into an “us vs. them” mentality where CROs are viewed as vendors who simply execute their client’s predetermined plans with minimal oversight from the sponsor company. This mindset misses a crucial opportunity for sponsors to leverage FSP partners as strategic partners.

CROs have seen what works across different organizational cultures, therapeutic areas, and portfolio complexities. Through the experience of our own companies’ partnership, a consistent theme has emerged.

Success requires both parties to meet each other halfway, across four critical factors:

1. Dedicated Team Focused on Transition

As teams are built, organizations should also be prepared to commit dedicated resources to manage their transition, treating it as a strategic initiative rather than an additional responsibility layered onto existing roles. This effort requires clear ownership, accountability, and dedicated time to manage the complexity involved.

A critical first step is establishing overarching principles and guidance that studies will follow, creating a standardized framework before diving into study-specific details. This can include developing transition documents for both organizations—comprehensive checklists and an electronic trial master file (eTMF) that provide clear, repeatable processes.

By assigning dedicated points of contact to walk each study through the transition process, teams can receive hands-on support until the approach becomes routine. Investing substantial time in upfront planning—typically three to four months—before beginning to migrate studies to the new model is also key to success.

This includes evaluating each study's critical milestones, developing prioritization criteria for the transition sequence, and creating detailed phase implementation plans that minimize disruption. The goal is careful orchestration that protects ongoing deliverables and maintains quality standards throughout the change process.

2. Collaboration and Open Communication

The foundation of any strong partnership is collaboration. For sponsors and their FSP partners, this often means moving beyond traditional vendor relationships to create pathways for truly open communication.

The first step is to establish regular communication cadences that match the intensity of each transition phase, such as daily touchpoints during critical periods, gradually evolving to weekly or bi-weekly as work progresses. Both parties must come to the table in these moments ready to share insights and challenge assumptions, rather than defaulting to traditional client-vendor dynamics.

Collaboration should also extend to every aspect of the transition. For our teams, this included jointly developing tools such as operating manuals and comprehensive ways of working documents that clearly defined responsibilities in the new model.

Defining these roles throughout our partnership prioritizes transparency, openly discussing challenges, sharing concerns early, and working together toward solutions. Success also requires alignment across all organizational levels: from global leadership teams to therapeutic area stakeholders and individual study teams.

Each plays a critical role, and establishing this clear communication can ensure that solutions can be implemented swiftly at the appropriate level. Ultimately, the goal is to create an environment where all parties feel equally invested in the outcome.

3. Agile and Flexible Resourcing Approach

Flexibility is essential when managing the complex dynamics of transitioning studies while maintaining delivery timelines. By prioritizing critical, high-impact projects while maintaining flexibility on lower-priority programs, teams can focus resources where they matter most while adapting approaches based on real-world circumstances.

In our experience, this meant defining geographic and staffing strategies upfront while remaining flexible as realities emerged. For example, if more resources are needed in a region than originally anticipated, FSP support levels can be recalibrated based on actual availability.

This may include expanding into new regions to access talent and leveraging dedicated teams to maintain momentum during the transition period. When talent availability requires, this agility in execution—paired with clear strategic direction—has proven essential to success.

4. Continual Evaluation and Process Development

A successful transition is just the beginning. To maintain momentum and realize long-term value, organizations must focus on ensuring sustainability through ongoing evaluation, regularly assessing what is working and what requires modification.

This mindset of continuous improvement extends beyond the transition itself. While the transition our teams executed together resulted in zero missed deliveries of work, we continually evaluate our processes to ensure this progress continues.

The strongest programs continue to evaluate and evolve years into the future, with CROs and sponsors working together to identify opportunities to achieve strategic goals, whether transitioning legacy studies, reducing timelines, or fundamentally restructuring cost models.

It is also important that sponsors look ahead as it relates to industry talent. This might mean developing internship programs for recent graduates or recruiting from adjacent industries and providing training.

With FSP models often featuring more limited role definitions, it's crucial to create these intentional career progression opportunities, developing new ways of working and providing growth opportunities beyond what’s been seen in the past.

The Hybrid Future: Models that Meet Halfway

While some organizations seek to transition fully from FSO to FSP models, our industry is increasingly seeing the benefit of hybrid ways of working. These models offer the best of both worlds, with comprehensive services and efficiency of FSO combined with the flexibility and talent management capabilities of FSP.

This trend is particularly seen among larger biopharmaceutical companies that leverage a blend of FSO, FSP, and hybrid models depending on study complexity and strategic priorities. Emerging and mid-sized biotechs often gravitate toward FSO and hybrid solutions that provide necessary support without requiring extensive internal infrastructure, often to augment capabilities where they may not have those internal capabilities.

The key is recognizing that there is no single way forward when developing these strategies. The right model depends on multiple factors: portfolio complexity, internal capabilities, geographic needs, and strategic priorities. Success comes from thoughtfully evaluating these factors and designing a fit-for-purpose solution.

Because although the clinical research landscape will continue to evolve, organizations that embrace collaborative, flexible ways of working will be the ones best positioned to navigate this complexity. Ultimately, the future of clinical research outsourcing isn't about choosing sides between FSO and FSP.

It's about finding the right balance, building the right partnerships, and remaining agile enough to adapt as needs change. When sponsors and CROs truly meet halfway, this transformation becomes not just possible, but sustainable.

About the Authors

Kerri McCaul-Claus, Vice President, Head of FSP Biometrics, Parexel.

Allison Covucci, Executive Director, Statistical Programming, BMS.