The role of functional service providers in clinical research and drug development
In recent years, the pharmaceutical and biotechnology industries have witnessed unprecedented growth and transformation. As the pace and complexity of drug development increase, sponsors are turning to functional service providers (FSPs) to enhance efficiency, reduce costs, and accelerate the time to market.
What is an FSP in clinical research?
Drug development is a multifaceted and challenging process involving discovery, preclinical testing, clinical trials, regulatory approvals, and commercialization. FSPs in clinical research have emerged as strategic partners, offering specialized services that enable sponsors to focus on their core competencies while leveraging external expertise for specific functions. By outsourcing specific functions such as clinical monitoring, data management, biostatistics, and pharmacovigilance, sponsors can optimize financial and human resource allocation, improve operational flexibility, and enhance overall productivity.
Benefits of partnering with an FSP CRO
Outsourcing specific functions to an FSP clinical research partner offers several advantages, including:
- Access to specialized expertise. FSPs offer hands-on experience in various aspects of clinical trials and drug development, providing just-in-time, fit-for-purpose resources and eliminating the need for sponsors to develop in-house expertise.
- Scalability. Sponsors can scale services up or down based on program needs without long-term commitments.
- Accelerated timelines. FSPs often have established processes that can expedite the development timeline and facilitate transitions if the sponsor experiences turnover.
- Cost efficiency. Outsourcing reduces overhead costs associated with staffing, training, and infrastructure requirements.
Characteristics of the best FSPs in clinical trials
Top functional service providers distinguish themselves by embracing digital transformation, leveraging artificial intelligence (AI) and machine learning, and incorporating decentralized trial technologies to minimize patient burden while maintaining study integrity.
Top functional service provider partners in clinical research in 2025
Based on the characteristics described above, the top FSPs for 2025 are:
IQVIA
- Known for its comprehensive data and analytics solutions, IQVIA offers a range of functional services within their FSP model, which is designed to fit the depth and breadth of their clients’ clinical development needs. Functional services offered by IQVIA include end-to-end clinical development capabilities, data management services, statistical programming, biostatistics, medical writing, and lifecycle safety.1 IQVIA promotes its ability to deploy, scale, and integrate the precise expertise, services, and capabilities needed and to co-create flexible, case-by-case solutions that help ensure the fastest, most direct route to the augmentation needed.2
Parexel
- Parexel offers a robust FSP model that integrates seamlessly with the internal teams at biopharmaceutical companies to provide expertise across various roles, including clinical operations, data management, medical affairs, medical writing, regulatory, pharmacovigilance, and translational medicine. Their approach includes a hybrid model that combines full-service and functional services tailored to client needs. With its dedicated talent acquisition team, Parexel is continuously strengthening its infrastructure through hubs in the Americas, Europe, the Middle East, Africa, and Asia Pacific (APAC).3
Precision for Medicine
- Precision for Medicine delivers agile, scalable FSP solutions designed to accelerate clinical development and bridge expertise gaps globally. With 40+ offices across North American, European, and Asian Pacific (APAC) locations, Precision offers 24/7 coverage to ensure business continuity, increased efficiency, and reduced risk. Precision's FSP model focuses on strategically aligned teams, flexible scaling, and operational excellence. Key services include clinical monitoring, data management, biostatistics, statistical programming, medical writing, and pharmacovigilance. Supported by robust governance and tailored to project-specific needs, Precision’s FSP partnerships enable sponsors to adapt and advance with confidence.
Pharmaceutical Product Development (PPD)
- PPD provides access to a wide range of reliable, customizable resources to support key functional areas across every aspect of a drug development program, from site startup and monitoring to clinical data management and post approval strategy. They retain more than 30,000 expert research professionals and deploy their FSP capabilities in over 160 countries. PPD also offers an award-winning professional development program and has been recognized as a leading business for employee learning and development on Training magazine’s Top 100 list for 11 consecutive years.4
ICON
- ICON is the largest global provider of FSP services, with over 90 partnerships and more than 14,000 employees. They have deployed FSP solutions across all major functional areas, from clinical monitoring and project management through data management, statistical, and beyond.5 ICON offers three primary FSP models—functional resourcing that provides individual resources or small teams to supplement existing client teams, functional outsourcing that offers complete outsourcing for specific areas of clinical development, and full-service FSP that delivers end-to-end clinical development services.
Syneos Health
- Syneos Health offers a unique FSP model that combines clinical development with commercial expertise. They have developed a solution called FSP 360 to provide a customized outsourcing approach that prioritizes flexibility and fitness for purpose, with the aim of easing the burden of resource management without sacrificing sponsor visibility. FSP 360 considers the most appropriate model, technology, process optimization, and metrics for each client, with the objective of building a customized FSP clinical trial solution that delivers speed, flexibility, quality, and efficiencies.6
Premier Research
- Premier Research provides FSP services with a focus on small- to mid-sized biopharmaceutical companies, offering flexible options across the clinical development continuum. They offer expertise in niche therapeutic areas such as rare diseases and pediatrics and have been partnering with leading sponsors to deliver both long-term and project-specific support for key functions since 1998. Premier Research provides access to a dedicated team of experts around the world, including those in key life science hubs in emerging markets such as APAC.7
Catalyst Clinical Research
- Catalyst challenges the FSP status quo by providing approaches that are individually tailored and adaptable to each client’s changing needs. In their capacity as an FSP, they have served more than 180 clients on over 1,100 projects across functional areas, including clinical operations, data management, biostatistics and programming, and medical writing.8 Catalyst boasts over 7,000 subject matter experts and an 88% staff retention rate, ensuring consistency throughout projects.9 In addition to more common clinical operations services, they offer expertise and established processes for project governance and risk management.
Quanticate
- Quanticate offers FSP services to clients ranging from small biotechnology companies to Top 5 global pharmaceutical companies. As a specialist CRO focused exclusively on biometrics, Quanticate provides expertise in statistical programming, biostatistics, and clinical data management and can also support additional core services such as medical writing, pharmacovigilance, monitoring, and project management. They offer four different functional service provision models, from a staff augmentation FSP model to a full-service FSP model, enabling clients to customize their outsourcing strategy.10
Partnering with right FSP
Successful clinical trials require specialized, customizable support that leverages broad functional service and therapeutic area expertise. As sponsors face increasing pressure to innovate and deliver safe, effective therapies efficiently, their reliance on FSPs continues to grow. Whether delivering an individual resource, a single function within a trial, or a fully outsourced clinical trial management solution, FSPs can help sponsors achieve high-quality, cost-effective results.
Explore the ways an experienced and agile FSP optimizes adaptability, integration, and scalability at every stage of development.
References
- IQVIA. Functional services. Available at https://www.iqvia.com/solutions/research-and-development/functional-services.
- IQVIA. Fueled by efficiencies. Driven by excellence. Available at https://www.iqvia.com/solutions/research-and-development/functional-services.
- Parexel. FSP Deliver Models in Clinical Trials. Available at https://www.parexel.com/solutions/fsp-delivery-models-in-clinical-trials.
- PPD. PPD FSP solutions deliver the top-tier expertise you want and the on-time delivery you need. Available at https://www.ppd.com/our-solutions/clinical/functional-service-providers/.
- ICON. ICON Strategic Solutions. Available at https://careers.iconplc.com/icon-strategic-solutions.
- Syneos Health. Functional Service Provider (FSP 360). Available at https://www.syneoshealth.com/solutions/clinical-development/fsp-360.
- Premier Research. Functional Service Provider (FSP). Available at https://premier-research.com/capabilities/functional-service-provider-fsp/.
- Catalyst Clinical Research. Functional Service Provider for Innovative Solutions. Available at https://catalystcr.com/catalyst-flex/,
- Catalyst Clinical Research. Global Support to Fit Clinical Trial Management Needs. Available at https://catalystcr.com/functional-expertise/.
- Quanticate. Functional Service Provision. Available at https://www.quanticate.com/functional-service-provider.