01 · Non-disruptive
Works inside your existing workflow
No rip-and-replace. Clymbr Hub slots into your established SAP, programming and review process, so teams learn it and implement it fast.
Clymbr Hub
Protocol to CSR automation powered by the Clymbr Hub.
A unified AI-assisted, metadata-driven platform connecting Data Mapper, SAP Builder, TFL Designer, Code Generators, TFL Viewer, and CSR Builder, from analysis intent through approved CSR content.
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
Clymbr Hub Workflow
From raw data to submission-ready CSR , one connected workflow.
EDC and raw sources flow through Data Mapper, TFL Designer + Code Generators, and TFL Viewer + CSR Builder , all running on the validated Statistical Computing Environment underneath.
Clymb's validated foundation layer
Clymb's Statistical Computing Environment (SCE)
The validated, GxP-ready environment the entire flow runs inside , study code, data and execution history in one controlled space.
LLM layerGitHubSASRPythonVS Code
A metadata-driven, AI-enabled clinical platform
The entire clinical data lifecycle, automated.
EDC / Raw → USDM · CDASH · SDTM · ADaM · ARS · TFL · CSR
Step 01Clymbr Hub module Runs on SCE
Data Mapper
EDC and raw sources are mapped to SDTM and ADaM through AI-assisted specifications, sponsor-controlled standards, and built-in CDISC compliance checks.
- 50–60% reduction in manual SDTM / ADaM mapping time
- AI-assisted mapping with human-in-the-loop review
- Built-in CDISC compliance and validation rules
Inputs
EDC / raw dataSDTM specADaM specControlled terminology
Outputs
SDTM datasetsADaM datasetsMapping specDefine.xml
SCE powers every step · Raw data → submission-ready CSR
Step 1 of 4 · use ← → to explore
SCE · validated foundation layer for the entire workflow
Measured impact
Numbers from real programs
Benchmarks observed across studies delivered on the Clymbr Hub and validated statistical computing environment.
01
50–60%
Reduction in manual SDTM / ADaM mapping time
02
80%
Less SAP authoring effort with SAP Builder
03
85%
Faster TFL shell creation, review and approval
04
60%
Reduction in output programming and QC
05
70%
Less TFL review and approval time in TFL Viewer
06
40-50%
Cost savings (modeled on a medium complexity Phase II study with roughly 25 SDTMs, 14 ADaMs, and 100 TFLs)
Overall benefit
What changes when Clymbr Hub runs your reporting.
02 · Standardization
SAP & TFL aligned to CDISC
- Sponsor-specific SAP and TFL templates, standards and conventions
- Aligned with CDISC AC/DC and CDISC ARS/ARD via SAP Builder and TFL Designer
- Output generation powered by the ARD model
03 · Gen-AI CSR
Interact with your results
CSR Builder brings Gen-AI to result interrogation, validation and CSR automation , drafting narratives and in-text tables from machine-readable, approved TFLs.
Coverage: CSR · ISS/ISE · Annual Reports · IB · DSUR
85%
Faster TFL shell creation
50–60%
Less output programming effort
70–80%
Faster, higher-quality code with the AI Code Generator
See the Clymbr Hub in action
How our solutions have helped clients
TFL Designer Case Study
How Clymb reduced programming time by 40% on an ISS submission.
Learn moreSiera Case Study
Rescued a failing BIMO with quality processes and fast turnaround.
Learn moreTFL Viewer Case Study
Built a cross-functional team ensuring document readiness and compliance.
Learn moreLet's Connect
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