The 2026 state of FSP outsourcing: challenges, trends, opportunities and the future of clinical development

How FSP partnerships enable sponsors to navigate uncertainty, accelerate innovation and deliver clinical trials with additional speed and flexibility.

Drug development has always been complex and is becoming increasingly unpredictable. Sponsors are balancing rising clinical trial costs, expanding protocol complexity, evolving regulatory expectations and persistent patient recruitment challenges, all while operating in an uncertain macroeconomic environment. As pressure mounts to deliver therapies faster and more efficiently, organizations continue to rethink strategies on how to resource clinical development.

The PPD™ clinical research business of Thermo Fisher Scientific published its fourth annual Pulse Report—an annual survey of 150 leaders from biotech and pharmaceutical organizations worldwide. Our 2026 FSP Trends Report highlights key survey insights from The Pulse and reveals that functional service provider (FSP) partnerships continue to play an increasingly strategic role in helping sponsors navigate these challenges. Rather than simply serving as a staffing solution, FSP models continue to lay the foundation for long-term partnerships that provide specialized expertise, global scalability and operational flexibility across the clinical development lifecycle.

Clinical development in 2026: More uncertainty, greater complexity

The current clinical development landscape reflects an industry facing unprecedented operational pressures. According to survey respondents, the top challenges impacting clinical development today include:

• Rising costs (55%)
• Patient recruitment (39%)
• Navigating the changing regulatory landscape (35%)
• Increasing complexity (31%)
• Macro environment/economic uncertainty (27%)
• Contract research organization (CRO) partnership dynamics (27%)

Notably, regulatory complexity has emerged as one of the industry’s fastest-growing concerns after not ranking among the top challenges in the previous year’s survey. At the same time, clinical trials continue to be more demanding, with Phase III studies now involving substantially more procedures, endpoints, countries and investigative sites than a decade ago.¹

These pressures are driving organizations to seek outsourcing models that provide additional agility without sacrificing oversight or quality.

FSP outsourcing continues to gain strategic importance

The latest Trends Report shows that sponsors continue to diversify how they outsource clinical development work:

• 26% through mixed FSP/FSO models
• 11% through insourcing/temporary staffing
• 26% through dedicated FSP partnerships
• 36% through traditional full-service outsourcing (FSO)

Combined, FSP and insourcing models now account for 37% of current clinical development work, demonstrating the continued shift toward function-specific operating models. Large pharmaceutical organizations are leading this trend, relying on FSP models more heavily than smaller companies.

Many sponsors are combining approaches, using mixed FSP/FSO models to retain closer control of strategically important functions and access specialized expertise to augment end-to-end capabilities of FSO arrangements.

Sponsors are leveraging FSP partnerships to navigate the biggest clinical development challenges

• Rising clinical trial costs
  Cost remains the industry’s most significant concern. Clinical trial delays carry substantial financial implications, making operational efficiency more important than ever. Sponsors increasingly leverage FSP partnerships to access global talent through remote-based regional hubs, enhancing recruitment speed, resource utilization and around-the-clock productivity without expanding permanent infrastructure.
• Patient recruitment
  Despite years of innovation, patient recruitment continues to delay clinical programs worldwide. Experienced FSP partners enable sponsors to broaden their access to diverse patient populations across global networks, localized expertise and expansion into non-footprint countries. These capabilities enhance enrollment while supporting patient-centric trial execution.
• Regulatory uncertainty
  One of the biggest changes reflected in this year’s report is pervasive uncertainty. As global regulatory expectations continue to evolve, sponsors require continuous intelligence, local expertise and scalable regulatory support. As the regulatory environment becomes increasingly complex and unpredictable, regulatory affairs has emerged as a critical pressure point. FSP partnerships provide dedicated regulatory specialists, global publishing capabilities and real-time regulatory intelligence so that organizations maintain compliance and minimize delays across increasingly complex submissions.
• Increasing trial complexity
  Modern clinical trials involve more endpoints, countries, sites and operational coordination than ever before. FSP partnerships allow sponsors to embed specialized functional expertise directly within clinical programs while providing scalable infrastructure, standardized processes and experienced teams capable of managing increasingly sophisticated studies.
• Economic uncertainty and evolving partnership models
  Today’s sponsors must remain flexible and agile. Rather than maintaining fixed internal resources, organizations increasingly rely on FSP partnerships that allow teams to scale up or down as programs evolve. This flexibility allows sponsors to respond more effectively to changing budgets, shifting priorities and uncertain market conditions while maintaining progress across clinical programs.
  

Emerging FSP strategies shaping the current landscape, and beyond

As outsourcing models mature, the role of FSP partners continues to expand beyond traditional resourcing. Our FSP Trends Report highlights several emerging strategies transforming clinical development.

• Accelerating AI adoption
  Sponsors increasingly rely on FSP partners to operationalize artificial intelligence (AI) across functions like pharmacovigilance, medical writing, clinical data management and trial operations.
  
  AI-supported workflows automate repetitive processes, reduce manual effort, improve consistency and accelerate study startup while allowing experienced clinical professionals to focus on higher-value scientific work. Rather than replacing expertise, AI is a critical tool that complements human decision-making.
• Leveraging global delivery models
  Remote-based regional hubs continue to reshape clinical operations. These globally distributed teams provide the best-suited and most cost-effective professionals for the job while enabling “follow-the-sun” operations that enhance productivity, accelerate delivery and support around-the-clock project execution.
• Managing regulatory complexity
  As regulatory expectations become increasingly dynamic, sponsors are turning to FSP partners for lifecycle regulatory support, publishing expertise and global regulatory intelligence. With these capabilities, organizations maintain compliance while accelerating submissions across multiple markets.
• Strengthening pharmacovigilance
  Growing volumes of safety data require scalable, standardized pharmacovigilance processes. Modern FSP partnerships centralize safety operations, integrate automation, enhance reporting consistency and strengthen regulatory compliance throughout the product lifecycle.
• Transforming clinical data into strategic insight
  Clinical data management is evolving into a broader data science capability. By integrating diverse data sources with advanced analytics and AI, FSP partners enable sponsors to identify risks earlier, improve decision-making and generate actionable insights that enhance study performance.
• Advancing clinical operations
  From patient recruitment and monitoring to risk-based quality management (RBQM), FSP partners continue expanding their role across clinical operations. Scalable resourcing, automation and centralized operational support allow sponsors to reduce administrative burden while enhancing efficiency, oversight and execution quality.

Meet your timelines with
PPD FSP solutions

Today’s clinical development environment demands more than additional staffing. Sponsors increasingly require strategic partners capable of providing specialized expertise, global scalability, technology enablement and operational resilience throughout the clinical development lifecycle.

PPD™ Functional Service Partnership (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 deliver a breadth and depth of therapeutic and functional expertise unmatched in the industry, 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, open, transparent and timely 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 to provide much-needed resource flexibility, reliability and continuity.

FSP Trends Report

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