Clymb Clinical
Data Mapper logoCLYMBR HUB · SDTM & ADAM

Data Mapper

AI-powered EDC → SDTM → ADaM mapping, governed by metadata.

Data Mapper is an AI-powered EDC to SDTM and SDTM to ADaM mapping platform. It delivers end-to-end clinical data mapping driven by a central Metadata Repository, and its built-in AI generates SAS and R code from approved mapping specifications so programmers ship faster without losing traceability.

  • EDC → SDTM and SDTM → ADaM in one tool
  • Central Metadata Repository (MDR)
  • AI-assisted SAS and R code generation
  • CDISC-aligned mapping specifications
50–60%
Less manual mapping time

AI-assisted raw → SDTM → ADaM mapping sharply reduces programmer hours on specification and mapping work.

30–50%
Faster dataset delivery

CDISC-driven metadata, rule sets, standard macros, and production-ready code generators accelerate SDTM and ADaM production and QC.

100%
CDISC compliance by design

SDTM, ADaM, define.xml, and aCRF are generated natively to CDISC standards, reducing downstream remediation.

Capabilities

What Data Mapper does

A metadata-driven path from raw EDC data to analysis-ready ADaM, with the code and submission documents generated alongside it.

01

AI-assisted raw → SDTM mapping

Point Data Mapper at raw EDC extracts and it proposes domain, variable, and value-level mappings for review.

02

SDTM → ADaM derivation

Define analysis datasets from approved SDTM using reusable, metadata-driven derivation rules.

03

Central Metadata Repository

Mappings, standards, and rule sets live in a governed MDR that can be pinned per study and reused across a program.

04

Production-ready code generation

Generate SAS and R programs directly from approved mapping specifications, ready to execute in the SCE.

05

Submission documents by default

define.xml, aCRF, and specification documents are generated natively from the same metadata.

06

End-to-end traceability

Every ADaM variable traces back through SDTM to the source CRF field, with change history for each version.

How it works

Data Mapper in the workflow

Data Mapper sits at the front of the Clymbr Hub flow, feeding approved analysis datasets into SAP Builder and TFL Designer.

Load raw data

Ingest raw EDC extracts and reference the study CRF and standards in the metadata repository.

Map to SDTM

AI proposes domain and variable mappings; programmers review, adjust, and approve the specification.

Derive ADaM

Build analysis datasets from approved SDTM using governed derivation rules and sponsor standards.

Generate and QC

Produce SAS or R code, define.xml, and aCRF, then execute and QC inside the SCE.

Key functionalities

Everything included in Data Mapper

A secure, cloud-based module of Clymbr Hub , governed, versioned, and audit-ready from day one.

11 capabilities shipped today
Capability

Secure cloud-based, scalable solution

Select any capability to see what it does.

What is AI-powered EDC to SDTM and ADaM mapping?

AI-powered EDC to SDTM and ADaM mapping is the use of AI over protocol, CRF, SAP and study metadata to draft how every raw EDC field becomes a CDISC SDTM variable, and how approved SDTM becomes ADaM analysis datasets. Clymb Clinical's Data Mapper, a module of Clymbr Hub, produces those mapping specifications in a governed Metadata Repository, generates the SAS and R code that implements them, and keeps a statistical programmer in control of every approval.

Raw EDC → SDTM

EDC-agnostic ingestion with AI-proposed domains, variables, value-level mappings and controlled terminology.

SDTM → ADaM

Governed, reusable derivation rules for ADSL, BDS and OCCDS with population and parameter metadata.

Code + define.xml

Production-ready SAS and R programs, define.xml and aCRF generated from the same approved metadata.

Teams report 50-60% less manual mapping time and 30-50% faster SDTM and ADaM delivery, with 100% CDISC-compliant outputs and end-to-end traceability from source CRF field to analysis variable, inside a 21 CFR Part 11 aligned statistical computing environment.

Standards & compliance

Built to the standards your submission expects

  • CDISC CDASH
  • CDISC SDTM
  • CDISC ADaM
  • Controlled Terminology
  • define.xml
  • aCRF
  • SAS
  • R
Who uses it

Teams working in the same workspace

  • Statistical programmers
  • Data standards leads
  • Data managers
  • Biostatistics leads
  • Submission teams
Common questions

About Data Mapper

What is AI-powered EDC to SDTM and ADaM mapping?+

AI-powered EDC to SDTM and ADaM mapping uses machine learning over protocol, CRF, SAP, and study metadata to propose how each raw EDC field maps into CDISC SDTM domains, and how approved SDTM maps into ADaM analysis datasets. Clymb Clinical's Data Mapper, part of Clymbr Hub, generates those mapping specifications, keeps them in a governed Metadata Repository, and auto-generates the SAS or R code that implements them, with a statistical programmer reviewing and approving every mapping.

What does Data Mapper do?+

Data Mapper converts raw clinical data from any EDC system into SDTM domains, then maps SDTM into ADaM analysis datasets. Mappings are stored as metadata in a central repository, and the tool auto-generates the SAS or R code, define.xml, and annotated CRF that implement them.

Which EDC systems does Data Mapper support?+

Data Mapper is EDC-agnostic. It ingests raw extracts from Medidata Rave, Veeva CDMS, Oracle Clinical/InForm, OpenClinica, and other systems, along with central lab and external vendor feeds, in formats such as SAS datasets, CSV, and Excel.

How much time does AI-assisted SDTM and ADaM mapping save?+

Teams using Data Mapper report 50-60% less manual mapping time and 30-50% faster SDTM and ADaM dataset delivery, because AI drafts the mapping specifications and generates production-ready code instead of programmers writing both by hand.

Does Data Mapper follow CDISC standards?+

Yes. Data Mapper is CDISC-aligned across CDASH, SDTM, ADaM, Controlled Terminology, and define.xml. Sponsor standards are versioned centrally, can be pinned per study, and reused across a compound or program, with CDISC conformance checks built in.

Is AI-generated mapping validated and traceable?+

Yes. Every AI suggestion is human-in-the-loop: a programmer reviews and approves each mapping. Data Mapper runs in a 21 CFR Part 11 aligned statistical computing environment with version control, audit trails, and role-based access, and every ADaM variable traces back through SDTM to the source CRF field.

Can I export the generated mapping code?+

Yes. Generated SAS and R programs, mapping specifications (Excel, CSV, JSON), and define.xml can be exported, versioned in the SCE, and executed inside Clymbr Hub or in your existing environment.

See Data Mapper inside Clymbr Hub.

Bring your team, your study, and your code. We'll show you Data Mapper working end-to-end alongside the rest of the platform.