01
Full project outsourcing
Hand over the whole data package , biostatistics and statistical programming owned end to end, from protocol through submission.
Outsourcing
Biostatistics & statistical programming outsourcingProtocol design through submission-ready packages.
Biostatisticians and statistical programmers who own the deliverable, protocol design through submission-ready packages, inside a validated, audit-ready environment.
20+
Customers
100+
Ongoing trials
SAS + R
Validated environments
15+
Years average team member experience
Supported deliverables
From raw data to submission-ready CSR.
Clymb delivers the core data package , SDTM, ADaM, TFLs, and CSR , while receiving sponsor inputs and external vendor feeds.
Clymb's Outsourcing Supported DeliverablesClymb deliverables
Supported by the Clymbr Hub platform — automation and AI-assisted solutions that drive accuracy, speed, and regulatory readiness across every deliverable.
Powered by CLYMBR HUB platform
Clymb deliverable
CDISC-conformant SDTM domains with annotated CRF and define.xml.
The outsourcing model
Four things you get, every engagement.
Full project outsourcing run on Clymb SOPs, staffed by our team, and priced against automation , not headcount.
02
Clymb SOPs, team and process
Delivered on our SOPs, with our senior team and our validated process , no borrowed frameworks, no ramp-up tax on your side.
03
Clymbr Hub automation and AI
Every engagement runs on the Clymbr Hub platform , giving sponsors direct access to automation and AI-assisted solutions for the study. Review outputs, track progress, and collaborate in real time with no separate licensing required.
04
Cheaper and faster
Clymb automation plus low/mid-cost delivery centers compress both budget and timeline without touching the quality bar.
Specific data focus , away from the typical CRO “data second” model
Competitive pricing using Clymb automation and offshore team; average 30–40% savings versus competitors
Expedited timelines using Clymb automation to allow quicker access to data
Extremely effective for niche projects and specialty work
Biostatistics & statistical programming
Capabilities
Take the full program or a single function , scope is yours, quality bar is ours.
01
Protocol design
Expert protocol design services that ensure objectives are met, data is captured accurately, and risks and benefits are balanced.
02
Study design and sample size calculation
Sample size calculations, power calculations, and statistical design recommendations for clinical trial planning.
03
SAP and statistical reports
Statistical Analysis Plans and Statistical Reports , including interim analyses , with the highest statistical rigor.
04
Randomization services
Unbiased treatment allocation and randomization services that minimize the risk of bias in study results.
05
SDTM mapping
Accurate, consistent SDTM mapping enabling seamless integration of clinical data from different sources.
06
ADaM and TFL programming
ADaM and TFL programming with advanced visualization for interactive, dynamic TFLs , accurate results, reported efficiently.
07
ISS / ISE
Integrated Summary of Safety (ISS) and Efficacy (ISE) reports and data submission expertise for regulatory compliance.
08
Regulatory submission support
Guidance for IND, NDA, and BLA submissions with the FDA and support for submissions to EMA, PMDA, and other agencies worldwide.
09
Rescue work
Rescue work for clients dissatisfied with their current CRO , ensuring continuity of the clinical trial and rescuing it from failure.
Specialty projects
One stop for everything around the core package.
Flexible, customizable support for the work that sits beside the main deliverable , from BIMO packages to publications.
Standalone or bundled
No minimum study size
Fixed-scope pricing
Runs on Clymb SOPs
Specialty support map01 / 09
Regulatory
BIMO datasets & listings
Site-level BIMO datasets, listings, and the accompanying documentation for inspection readiness.
Regulatory
BIMO datasets & listings
Site-level BIMO datasets, listings, and the accompanying documentation for inspection readiness.
Safety
DSUR & safety reporting
Annual DSUR tables, periodic safety outputs, and ad hoc safety data cuts on request.
Standards
CDISC compliance support
Conformance review, define.xml, reviewer's guides, and remediation of legacy standards gaps.
Regulatory
Ad Comm support
Rapid-turnaround analyses, briefing-book outputs, and back-room support during advisory committees.
Automation
Automation services
Automation for data mapping, analysis, and reporting , built once, reused across every study cut.
Regulatory
Results posting in CT.gov
Results package preparation, QC, and posting support to meet registry disclosure deadlines.
Reporting
Publications support
Analyses, figures, and tables prepared for manuscripts, abstracts, and conference posters.
Infrastructure
SCE setup & configuration
Consulting on statistical computing environment setup, validation, and access governance.
Enablement
Training & support
Team training and ongoing support so your staff can run and extend what we deliver.
Specialty support, scoped to what you need
Pick any item on its own or bundle it with a study , regulatory packages, safety reporting, publications, and SCE consulting are all available as standalone engagements.
FAQs
Got questions? We've got answers.
What does Clymb Clinical's biostatistics outsourcing cover?+
We provide end-to-end biostatistics and statistical programming outsourcing from protocol design and SAP development through SDTM, ADaM, TFLs, ISS/ISE, and regulatory submission-ready packages. Senior biostatisticians and statistical programmers own every deliverable inside a validated, audit-ready SAS/R environment.
How is Clymb different from a traditional CRO outsourcing model?+
Traditional CROs often treat data as a secondary function. Clymb concentrates on the core data package, uses Clymbr Hub automation, and leverages low/mid-cost delivery centers so sponsors see 30–40% savings while senior clinical data experts retain ownership of quality.
Who actually works on my study?+
Your project is staffed by senior biostatisticians and statistical programmers with an average of 15+ years of experience. They work as an extension of your team, own the deliverables, and communicate directly with your clinical data and medical writing groups.
What software and environments do you use?+
We run validated SAS and R statistical software packages in Microsoft Azure cloud environments. Every study is supported by Clymbr Hub, our validated Statistical Computing Environment, with built-in project management, programming workspaces, and audit trails.
Can you support both full outsourcing and standalone functions?+
Yes. You can hand over the full program or select individual functions such as sample size calculation, randomization, SDTM mapping, ADaM programming, TFL generation, or regulatory submission support. Scope is yours; the quality bar is ours.
Are your processes audit-ready and regulatory compliant?+
Yes. We follow Clymb SOPs aligned with CDISC, ICH, and FDA/EMA/PMDA expectations. Outputs are produced in a validated, 21 CFR Part 11-aware environment with full traceability for inspection readiness.
What therapeutic areas and phases have you supported?+
Our team has contributed to early-phase through late-phase and post-marketing studies across oncology, immunology, cardiology, infectious diseases, rare diseases, neuroscience, and many other therapeutic areas.
How is pricing structured for outsourcing engagements?+
We offer Time and Materials (T&M) and Fixed Unit-based pricing. Because Clymbr Hub automation compresses effort, sponsors typically reduce cost and timeline compared to traditional outsourcing models. Contact us for a scoped quote.
Let's Connect
Tell us what you need , we'll reply within one business day.
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