FSP vertical
Data management
Database design, build, and validation , plus data cleaning, coding, and standardization for reliable, submission-ready datasets.
Functional Service Provider
A flexible, cost-effective FSP model built around your program.
Our FSP model lets sponsors leverage the expertise and resources of external providers to support specific functions or tasks within their clinical trial programs. We're committed to customized solutions that meet your needs and ensure the successful completion of your trials.
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.
How does Clymb differentiate between an FSP and an Outsourcing model?+
In the FSP model, you gain customized control over data, timelines, and processes through an insourced approach , dedicated project resources guided by Clymb's Project Manager. Outsourcing, by contrast, focuses on specific data functions and leverages our automation and low/mid-cost centers for significant cost savings , highly effective for niche projects and specialized tasks.
What's your experience across therapeutic areas and phases?+
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 others.
Let's Connect
Tell us what you need , we'll reply within one business day.
We partner with pharma, biotech, CROs, and technology vendors on platform access, outsourcing, and FSP delivery.
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