Functional Service Provider (FSP 360)
Built for acceleration. Designed around you.
As customers look for the optimal clinical trial outsourcing solution to drive productivity in clinical development, typical static functional service provider (FSP) models no longer meet increasingly complex scientific and operational needs. Today's sponsors require comprehensive FSP services that deliver both strategic value and operational excellence.
Syneos Health® has developed FSP 360 to provide a customized outsourcing approach that prioritizes flexible, agile FSP services, designed to ease the burden of resource management and functional delivery while enabling sponsor visibility and control of clinical development.
By taking a 360-degree view, we consider the right model, technology, process optimization and metrics for each customer, and then build a customized FSP clinical trial solution to meet your individual needs and goals. Backed by more than 25 years of experience, we bring the people, precision and performance you need, all in one purpose-built model.
We call it harmonization, optimization and transformation, and we don’t just say it. We’ve proven it. 97% of our FSP 360 customers return year after year.
Providing an array of FSP 360 services anytime during the clinical development lifecycle
With FSP 360, engagements can be scaled based on where you are in your outsourcing evolution. Our FSP services range from accessing specific functional excellence to expanding or supporting internal capabilities, to a multifunction outsourced FSP providing a combination of clinical research capabilities across an entire portfolio. We've helped global sponsors to scale and enabled emerging biotechs to move faster with less lift.
From embedded leadership to on-demand capacity, FSP 360 aims to deliver speed, flexibility, quality and efficiencies. We build what matters most: confidence and results.
The FSP 360 difference: Why choose Syneos Health for your FSP needs?
Focused leadership
Our dedicated FSP business line ensures critical focus on FSP-required investment and delivery oversight methodology, enabled by our expert functional managers.
Maximized outcomes, minimized risk
We lead with quality, measured through outcome-based KPIs and proactive risk management. We've delivered >97% KPI achievement through disciplined execution and tech-enabled delivery models.
Smarter hubs built to scale
We help optimize hub strategy and co-develop centers of excellence, aligning role, region and function to needs. With seven global hubs, we scale delivery models that flex with your portfolio.
Brand ambassadors at the site level
Our CRAs build site trust, protect your brand and keep trials on track. Sites remember how your study makes them feel so we strive for continuity that results in better outcomes.
People and performance
Everyone sources people. We engineer performance. Value doesn't come just from who you hire, it comes from what they're set up to deliver and the outcomes they provide.
Cultural alignment
We understand and live your culture. Our team is dedicated and aligned at the country level and we focus from the start on being an extension of your team.
FSP 360 in action: Real outcomes. Real impact.
Top-10 Biopharma | 436 Hires, 45 Countries
- Stood up new cross-functional FSP model as new primary partner in 3 months
- 40% internal talent, 4x hiring acceleration
- Validated Syneos Health as strategic scale-up partner
Top-5 Pharma | Data Management Overhaul
- $12M saving + 50% faster EDC builds
- 300+ global FTEs deployed with standardized processes
- Created repeatable blueprint for further partnerships
Top-20 Pharma | Full Model Transformation in 3 Months
- Embedded governance, aligned KPIs and joint workstreams
- +23% clarity gain, double-digit metric improvements
- Leadership visibility and trust surged across survey data
Syneos Health FSP 360 Services
- Administrative Services
- LMS Support
- CTMS Admin Support
- KPI/Dashboard Maintenance
- Program and Project Management
- Clinical Operations
- Clinical Monitoring
- Risk-Based monitoring enablement
- Centralized data review
- Study start-up
- Site contracts and budgets
- Site ethics and country regulatory submission
- Site activation
- Safety and Pharmacovigilance
- Signal detection and case processing
- Expedited and periodic reporting
- QPPV Office consulting and support
- Biometrics
- Clinical data management
- Biostatistics and statistical programming
- Clinical Trial Investigator Management Services
- Global investigator payments
- Sunshine Act/transparency and cash forecast reporting
- Patient reimbursement services
- Trial Master File Operations
- Electronic and paper TMF Management
- Independent TMF inspection readiness
and compliance Team
- Clinical Trial Closure
- Protocol registration and maintenance
- National registries
- End-to-end services
- Regulatory Affairs
- Pre- and post-Approval
- Strategy and intelligence
- Technology
CTMS=clinical trial management system; KPI=key performance indicator; LMS=learning management system; QPPV=qualified person responsible for pharmacovigilance; TMF=trial master file
Meet ClinQuest from Syneos Health
ClinQuest is our new virtual training program that combines world-class technology with Syneos Health’s deep learning and development expertise to bring a revolutionary tool to the biopharmaceutical industry. Leveraging the power of industry giants, EPIC Games and Amazon Web Services (AWS), this immersive tool creates a hyper-realistic environment where clinical research associates, investigators, and site staff engage in true-to-life, interactive simulations.
Consistency, speed and measurable performance across functions and geographies
97%+
KPI achievement through disciplined, outcome-based execution
6,500+
dedicated FSP professionals across 55 countries
7
global hubs and co-developed Centers of Excellence
20-day
time to fill
98%+
quality of hire, 70%+ preference in head-to-heads
Teams that stay:
>94% satisfaction and >90% retention in top partnerships
FSP partner
to eight of the top 10 global pharma companies
Your goal is our goal
Our priority is partnering with you to build dedicated, fit-for-purpose teams that align structurally and culturally with your organization.
- Our dedicated global resourcing team recruits top talent. Our Clinical Training Institute, employee engagement and stepladder programs support our people as they grow in their careers.
- We seed new FSP partnerships with a core team of experienced leaders who know how to establish a FSP program, engage relevant stakeholders, define program expectations and build collaborative governance as a foundation for excellence.
- Operational Leaders within the FSP functions are experts in the latest technologies and business processes.
- We offer a global footprint built with the fundamental understanding that in-country leadership is a critical success factor to growing and supporting staff within an FSP model.
We operate like it's our trial, too, because when you succeed, we all succeed by delivering life-changing therapies to the people who need them most.
This is why we work
A functional service provider (FSP) model in clinical development enables biopharmaceutical companies to outsource specific functions—such as data management, clinical monitoring or regulatory support—while retaining strategic oversight. FSPs deliver specialized expertise and scalable resources within the sponsor’s processes and systems, driving consistency, flexibility and operational efficiency across trials.
Clinical research associates (CRAs) play a critical role in clinical trials by ensuring protocol compliance, data accuracy and patient safety at investigative sites. As trials grow more complex and decentralized, CRA roles are evolving. Today’s CRAs must blend traditional site monitoring with adaptive approaches, including remote oversight and digital tool utilization. They collaborate closely with sites to proactively identify risks, support patient engagement and uphold quality standards—contributing to faster, more efficient trial execution in an increasingly dynamic research environment.
Related Content
Looking for exclusive insight?
