The 2025 State of FSP Outsourcing: Challenges, Trends and Opportunities, and the Future of FSP Strategies and Models

Discover how FSP and hybrid FSP/FSO models are helping sponsors better navigate clinical development outsourcing.

In the ever-evolving pharmaceutical landscape, biotech and biopharma organizations continue to embrace the critical importance of functional service provider (FSP) outsourcing.

The PPD™ clinical research business of Thermo Fisher Scientific conducted its third annual Pulse Report – a survey of 150 leaders from biotech and pharmaceutical organizations worldwide. Our 2025 FSP Trends Report highlights key survey insights from The Pulse, indicating an increased industry reliance on FSP partnerships and hybrid/mixed models that combine full-service outsourcing (FSO) with FSP engagements to handle the complexities of clinical trial innovations, manage costs and drive on-time performance.

FSP and hybrid FSP/FSO models are being used to help sponsors better navigate clinical development outsourcing in the top five areas where they are experiencing the greatest challenges:

• The rising cost of clinical trials: Drug developers efficiently expand their capabilities and complement their existing strengths by leveraging an FSP partner’s resources and expertise.
• Patient recruitment: Drug developers can advance and expand their clinical research by working with an FSP partner to access untapped patient populations.
• Increasing complexity of clinical trials: Drug developers can remain well-informed in an evolving global regulatory environment by working with an FSP partner with regulatory intelligence expertise.
• Maximizing asset value/ROI: Clinical trial sponsors can streamline the speed and efficiency of global resources by using a proven FSP partner with remote-based regional hubs.
• Feasibility and site selection: A strong FSP partner provides drug developers with comprehensive, data-driven feasibility assessments to proactively plan and optimize trials.

The survey also identified the top areas driving transformation in clinical development, and FSP engagements can help sponsors in the areas where they see the most opportunity, including:

• Innovative trial design (adaptive trial design, novel endpoints, biomarker-driven approaches, and multiple trial arms): Use of an FSP feasibility solution enables drug developers to leverage a comprehensive and data-driven approach.
• Personalized/precision medicine and AI: Top-tier FSP partners support the delivery of technological innovations by providing specialized resources and access to global talent and resources in cost-efficient locations.

Companies are also prioritizing the implementation of new technologies and patient-centricity strategies. The right FSP partner will help deliver technological innovations such as AI/machine learning (ML), electronic data capture, risk-based quality management (RBQM), and high levels of automation, and ensure that the trial design is patient-centric and aligned with the study’s unique demands.

As more sponsors adopt FSP and hybrid FSP/FSO outsourcing models to address and manage key drug development challenges, forward-thinking innovative strategies are being introduced by FSP partners to ensure efficient, timely delivery of drug developers’ projects.

These optimizations and tailored applications of the FSP model are essential for achieving on-time, on-budget results:

• Leveraging remote-based regional hub resources to meet your timelines
• Employing FSP models as the clinical operations function evolves
• Establishing bespoke outsourcing with hybrid FSP/FSO partnerships
• Harnessing FSP engagements for biotech
• Outsourcing lifecycle maintenance to a dedicated FSP regulatory affairs partner

Meet your timelines with PPD FSP solutions

As drug developers increasingly opt for FSP partnerships and hybrid FSP/FSO models, embracing trends and the evolution of FSP strategies is critical to overcome industry challenges.

Choosing the right FSP partner is critical to your drug development success. Nearly 400 companies have trusted PPD FSP solutions to support critical components of their drug development and post-marketing programs.

PPD FSP solutions help biotech and biopharmaceutical companies meet their timelines by delivering 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.