SAP authoring
80%Less effort
Structured, template-driven SAP authoring falls from ~100 hours to ~20 hours.
Clymbr Hub is live
The future of the clinical data pipeline.
Clymbr Hub connects protocol, CRF, SDTM, ADaM, SAP, TFL, and CSR authoring into one AI-assisted, metadata-driven framework , from study start to submission-ready outputs.
CLYMBR
HUB
DATA MAPPER + CODE GENERATORS
EDC / external data mapped to CDISC SDTM and ADaM standards
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SAP Builder
Structured, machine-readable SAPs
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TFL Designer + Code Generators
Digitized shells to production-ready SAS and R code
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TFL Viewer + CSR Builder
Review, approve, and assemble submission-ready reports
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SCE
Validated Statistical Computing Environment
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What we do
One platform, one suite of services, multiple ways to engage.
Clymbr Hub automates the analysis-to-submission path. Our delivery and tech-enabled services then run, extend, and support it for your program.
Technology
01
Clymbr Hub
Software that automates the analysis-to-submission path.
One integrated workspace connecting SAP metadata, TFL Designer, code generation, ARD review, and CSR authoring.
Metadata-driven SAP and TFL shells (CDISC ARS)Auto-generated, validation-ready TFL codeReview ARDs and draft the CSR in the same place
Explore the HubTechnology
02
Tech-Enabled Services
Specialist capabilities that extend the Hub.
On-demand technical expertise that plugs into your existing processes , from ARS/ARD implementation to custom automation and AI.
ARS/ARD ServicesCustom Macro DevelopmentAI ServicesValidation & Compliance
See tech servicesDelivery
03
Outsourcing Services
Full-study biometrics, handled end to end.
Protocol design through statistical programming and regulatory support, delivered by senior clinical data experts.
Biostatistics, SDTM/ADaM and TFL programmingStudy-level ownership with defined deliverablesHub automation applied to every deliverable
See outsourcingDelivery
04
Functional Services (FSP)
Extend your team, keep your process.
A flexible model that adds external expertise for specific functions across your clinical program.
Embedded programmers and statisticians in your SOPsScale roles up or down by study phaseLong-term continuity across the portfolio
See FSP modelNot sure which fits? Talk to our team and we'll map it to your program.
By the numbers
Measured outcomes across the reporting lifecycle.
Every metric below comes from real sponsor programs delivered by Clymb teams using the same automation stack that powers Clymbr Hub.
SDTM / ADaM mapping
50–60%Less manual work
AI-assisted raw-to-SDTM-to-ADaM mapping removes most specification and mapping hours.
TFL shell creation
85%Faster
Shell development, review, updates, and approval drop from ~120 hours to ~18 hours per study.
Programming & QC
60%Reduction
AI-generated, production-ready SAS and R code takes first-draft programming from 1,600 to 650 hours.
TFL review & approval
70%Faster
Review per draft drops from 80–100 hours to 24–30 hours in one controlled workspace.
Savings per study
40–50%Estimated study cost savings
Modeled on a medium Phase II study with roughly 25 SDTMs, 14 ADaMs, and 100 TFLs.
Our story
From raw clinical data to submission-ready narrative.
Clymb was founded by biostatisticians and clinical programmers who kept meeting the same friction: disconnected specs, manual shells, and rework late in the cycle. We replaced that friction with structured metadata, automation and AI, so teams spend their time on science, not reformatting.
- Pioneering the integrated clinical data pipeline from Protocol to CSR
- CDISC & Regulatory standards aligned end to end
- Trusted by biotech sponsors and CROs worldwide
Data Mapper
SAP Builder
TFL Designer + Code Generators
TFL Viewer + CSR Builder
RAW
EDC / raw dataCLYMBR
HUB
Synthesis engineHUB
Submission
STATISTICAL COMPUTING ENVIRONMENT (SCE) + AI LAYER
Bhavin Busa
Principal & Co-founder
"Driving innovation in clinical data services through technology and open source solutions. Our community and enterprise tools , including TFL Designer and our analysis results automation suite , are built to make clinical development more efficient, accurate, and transparent, ultimately leading to better patient outcomes."
Colin Izzo
Principal & Co-founder
"We founded Clymb on one simple idea , hire great people and pair them with technology to create an efficient, cost-effective service model. Our mission is to be the leader in the next generation of service providers, expediting clinical development without sacrificing quality."
In the news
Why clinical reporting must centralize: from fragmentation to platform.
As complexity, speed, traceability, and compliance demands rise, the industry must shift from fragmented tools to centralized, metadata-driven platforms built for scale.
Reporting architecture
Clymbr
Hub
Hub
EDC
Labs
SAP
TFL
CSR
Submission
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.
Pharma / BiotechCROVendor / Partner