01
Full project outsourcing
Hand over the whole data package , biostatistics and statistical programming owned end to end, from protocol through submission.
Outsourcing
Your study, delivered end to end.SAS and R, senior hands only.
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.
Speciality 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.
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 , freeing your team to focus on strategic decision-making. The Outsourcing model concentrates on specific data functions and leverages our automation and low/mid-cost centers for significant cost savings, making it highly effective for niche projects and specialized tasks.
What software and tools are in place at Clymb Clinical to support outsourcing?+
We use validated SAS and R statistical software packages, accessible via Microsoft Azure cloud environments. We also employ our proprietary tools , SDTM Mapper, TFL Designer, and the broader Clymbr Hub suite , alongside open source solutions for a seamlessly integrated approach.
What's your experience across therapeutic areas and phases?+
Our team has contributed to numerous clinical trials from early-phase research to late-phase and post-marketing studies across oncology, immunology, cardiology, infectious diseases, rare diseases, neuroscience, and many others.
What's the pricing structure for Clymb's outsourcing services?+
We offer both Time and Materials (T&M) and Fixed Unit-based pricing to fit different project needs. Contact us and we'll collaborate with you to determine the most suitable model.
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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