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
Clymbr Hub: the AI platform that automates the Protocol-to-CSR workflow.
One AI-powered, metadata-driven platform connecting Data Mapper, SAP Builder, TFL Designer, AI Code Generators, TFL Viewer, and CSR Builder , from protocol and analysis intent through an approved, submission-ready clinical study report.
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
What is Clymbr Hub?
Clymbr Hub is an AI-powered clinical reporting platform that automates the Protocol-to-CSR workflow. It maps raw EDC data to SDTM and ADaM, turns protocol and estimand intent into a structured CDISC ARS-ready SAP, generates production SAS and R programs with matching QC scripts, and drafts CSR narratives and in-text tables from approved TFLs , all inside a validated, 21 CFR Part 11 aligned statistical computing environment with human review at every step.
- Scope
- Protocol → SAP → TFL → CSR, end to end
- AI role
- Mapping, code generation and CSR drafting, human-in-the-loop
- Standards
- CDISC SDTM, ADaM, ARS/ARD, Define.xml
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 moreProtocol-to-CSR automation: frequently asked questions
What is Clymbr Hub?
Clymbr Hub is Clymb Clinical's AI-powered clinical reporting platform that automates the Protocol-to-CSR workflow. It connects Data Mapper, SAP Builder, TFL Designer, AI Code Generators, TFL Viewer, and CSR Builder on one metadata-driven, CDISC ARS-aligned backbone running inside a validated statistical computing environment.
How does AI automate the Protocol-to-CSR workflow?
AI assists at each stage: mapping raw EDC data to SDTM and ADaM, turning protocol and estimand intent into structured SAP metadata, generating production-ready SAS and R programs with matching QC scripts from ARS shells, and drafting CSR narratives and in-text tables grounded in approved TFLs. Every AI output stays human-in-the-loop and fully traceable.
How much time and cost does Clymbr Hub save?
Programs running on Clymbr Hub report 80% less SAP authoring effort, 85% faster TFL shell creation, 50-60% less SDTM/ADaM mapping time, 60% less programming and QC effort, 70% less TFL review time, and 40-50% overall cost savings on a medium-complexity Phase II study.
Is Clymbr Hub compliant and submission-ready?
Yes. Clymbr Hub runs in a 21 CFR Part 11 aligned, GxP-ready statistical computing environment with full audit trails, versioning, and access control, and its outputs align with CDISC ARS/ARD, SDTM, ADaM, and Define.xml requirements for regulatory submission.
Does Clymbr Hub replace our existing systems?
No. Clymbr Hub is non-disruptive and slots into existing EDC, SAP, programming, and medical writing processes, so biostatistics, statistical programming, and medical writing teams adopt it without a rip-and-replace migration.
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