FSP vertical
Data management
Database design, build, and validation — plus data cleaning, coding, and standardization for reliable, submission-ready datasets.
Functional Service Provider
An FSP provider that supports specific functions or tasks within your clinical trial programs.
Embed senior biostatisticians, statistical programmers, data managers, and medical writers into your team. Our Functional Service Provider model gives you dedicated clinical data experts working inside your systems, SOPs, and governance — with the option to tap Clymbr Hub automation when you need it.
Compare engagement models
- Control
- Sponsor-led, your SOPs
- Scope
- Dedicated functional resources
- Ramp
- Weeks, scales with portfolio
- Best fit
- Sustained capacity needs
The model
Clymb Functional Service Model
- 1
Insourcing model
You keep control over data, timelines, and processes — our people work inside your systems, SOPs, and governance.
- 2
Resource-centric
Emphasis is on named resources assigned to your project, so knowledge stays with your program instead of rotating out.
- 3
Project management
A Clymb Project Manager owns delivery oversight, escalation, and reporting to ensure team goals and milestones are met.
- Control over data, timelines, and processes using an insourced model
- Allows your team to focus on strategy instead of day-to-day project work
- Emphasis on resources assigned to the project, with Clymb's Project Manager ensuring team goals are met
- Works for any-sized pharmaceutical or biotech company
Functional Service (FSP) verticals
Five core verticals we staff end-to-end, plus CDISC standards implementation layered across them.
FSP vertical
Biostatistics
Expert statistical consultation, analysis, and reporting from a team of senior biostatisticians supporting all trial phases.
FSP vertical
Clinical / Statistical programming
Customized SAS and R programming for generation of SDTM, ADaM, and TFLs across therapeutic areas.
FSP vertical
Data analytics & visualization
Interactive dashboards and reports built with R Shiny, Spotfire, and Tableau — turning trial data into insight.
FSP vertical
Medical writing
Clinical study reports, protocols, and regulatory documents including CSR, IND, and NDA — authored by experienced medical writers.
Cross-cutting
CDISC data standards implementation
Streamlined CDISC standardization to improve data sharing and the efficiency of clinical research and healthcare practices.
What we do better
Access a broad range of specialized expertise and resources without the overhead costs and management challenges of building an internal team.
Cost savings
Reduce overhead by outsourcing specific functions to external service providers instead of building a full internal team.
Access to specialized expertise
Tap a broad range of specialists and resources through Clymb, letting you complete complex tasks efficiently.
Scalability
Scale resources up or down based on project needs — without the overhead of maintaining a full-time in-house team.
Increased focus
Free your internal resources to focus on core competencies and strategic initiatives, not peripheral functions.
Complete Function Detail
Explore the full scope of each FSP vertical. Select a function to see the capabilities Clymb delivers.
Complete Function Detail01 / 05
Data Management
Governed data from collection to lock.
- Strategic program planning, protocol review, and EDC selection
- CRF design using the latest SDTM implementation guides
- Database design, development, and maintenance
- Data validation programming and testing (edit checks, manual review specs)
- Medical coding using WHODrug & MedDRA dictionaries
- SAE reconciliation and external data reconciliation
- Database lock, archival, and transfer
FAQs
Got questions? We've got answers.
What is a clinical trial Functional Service Provider (FSP)?+
A clinical trial Functional Service Provider (FSP) is a company that supplies dedicated experts to perform specific functions or tasks within a sponsor's clinical trial program. Rather than outsourcing the entire study, the sponsor retains control of strategy, systems, and governance while the FSP delivers specialized resources such as biostatisticians, statistical programmers, data managers, and medical writers.
Which clinical trial functions can Clymb support under an FSP model?+
Clymb supports biostatistics, statistical programming, data management, medical writing, data analytics and visualization, and CDISC standards implementation. Each function can be staffed as a dedicated resource or blended team working inside your environment and SOPs.
How does Clymb's FSP model differ from full outsourcing?+
In our FSP model, you keep control over data, timelines, and processes through an insourced approach with named resources and a Clymb Project Manager. Full outsourcing concentrates on deliverables and leverages Clymb's automation and delivery centers for cost savings. FSP is ideal when you want embedded expertise; outsourcing is ideal when you want end-to-end deliverables.
Can Clymb provide FSP support inside our systems and SOPs?+
Yes. Clymb's FSP resources can work directly within your validated systems, follow your SOPs, and align with your governance and quality frameworks. This preserves data ownership, audit trails, and program continuity while giving you access to senior clinical data expertise.
What therapeutic areas and trial phases does Clymb cover?+
Our team has supported clinical trials from early-phase research through late-phase and post-marketing studies across oncology, immunology, cardiology, infectious diseases, rare diseases, neuroscience, and many other therapeutic areas.
How quickly can Clymb scale FSP resources for my program?+
We maintain a global bench of senior biostatisticians, statistical programmers, data managers, and medical writers. Once we understand your program needs, we can typically place named resources within days and scale the team up or down as study demands change.
Does Clymb combine FSP resourcing with automation and AI tools?+
Yes. FSP clients can also leverage Clymbr Hub, our validated automation platform, for Data Mapping, SAP authoring, TFL generation, CSR authoring, and Statistical Computing Environment (SCE) workspaces. This gives you senior expertise plus automation without additional software licensing.
What is the pricing model for Clymb's FSP services?+
We offer flexible Time and Materials (T&M) and Fixed Unit-based pricing depending on the function, duration, and resource mix. Contact us to discuss a model that fits your program structure and budget.
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We partner with pharma, biotech, CROs, and technology vendors on platform access, outsourcing, and FSP delivery.
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