Functional Service Provider (FSP 360)
Every customer is unique. We believe every FSP solution should be, too.
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.
Syneos Health® has developed FSP 360 to provide a customized outsourcing approach that prioritizes flexibility and fit-for-purpose solutions, aiming 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 the customer, and then build a customized FSP clinical trial solution to meet your individual needs and goals across the entire asset portfolio.
FSP 360 is based on decades of experience and built to address today and tomorrow’s market realities.
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. 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, FSP 360 aims to deliver speed, flexibility, quality and efficiencies.
Syneos Health FSP 360 Services
- Administrative Services
- LMS Support
- CTMS Admin Support
- KPI/Dashboard Maintenance
- Program & Project Management
- Clinical Operations
- Clinical Monitoring
- Risk-Based Monitoring Enablement
- Centralized Data Review
- Study Start-Up
- Site Contracts & Budgets
- Site Ethics & Country Regulatory Submission
- Site Activation
- Safety and Pharmacovigilance
- Signal Detection & Case Processing
- Expedited & Periodic Reporting
- QPPV Office Consulting & Support
- Biometrics
- Data Management
- Biostatistics & Programming
- Medical Writing
- Protocol Design
- Clinical Study Reports & Manuscripts
- Regulatory Submission Documents
- Investigator Payments
- Global Investigator Payments
- Sunshine Act/Transparency & Cash Forecast Reporting
- Patient Reimbursement Services
- Trial Master File
- Electronic & Paper TMF Management
- Independent TMF Inspection Readiness
& Compliance Team
- Clinical Trial Closure
- Protocol Registration & Maintenance
- National Registries
- End-to-End Services
- Regulatory
- Pre- and Post-Approval
- Strategy & 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
FSP support wherever you
need it
Bespoke FSP 360 models can be focused by service, geographically and therapeutically aligned, and easily integrated and scaled.
To help you navigate the increasing complexity of clinical trial planning, delivery and execution, we’re able to infuse our partnerships with innovative tech-enabled solutions for driving smarter decisions about protocol design and strategic feasibility, selecting the best countries and sites for your study, and for identifying precise, high-value patient pools for clinical trial recruitment.
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. FSP 360 staff operate as an extension of your team, bringing you greater flexibility, scalability and efficiencies – because patients are waiting.
- 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.
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.
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