H1ST-AI-STAT-004 · Task 3.1
Every data cut shouldn't restart your mapping
When the datasets are late, everything downstream waits with them, your TLFs, your define, your submission, and every mid-study transfer means re-running work you thought was done. This agent maps collected CRF data to SDTM domains and derives the ADaM analysis datasets that feed your TLFs, applying CDISC Controlled Terminology and traceability metadata as it goes. Weeks of manual SAS mapping and derivation become a governed, repeatable pipeline that regenerates cleanly on every data cut.
The grind you know
Hand-building SDTM domains and ADaM datasets is the slowest, most error-prone step you own, and every mid-study transfer drags you back to re-run and re-validate work you thought was finished. You know the findings that follow, inconsistent controlled terminology, an undocumented derivation, a broken trace, are exactly what Pinnacle 21 and FDA data-quality queries catch, so the pressure to get it right by hand never lets up.
Part of the Statistical Programming family
SDTM/ADaM, Define.xml, TLFs & analytics.
When the datasets are late, everything downstream waits with them, your TLFs, your define, your submission, and every mid-study transfer means re-running work you thought was done. This agent maps collected CRF data to SDTM domains and derives the ADaM analysis datasets that feed your TLFs, applying CDISC Controlled Terminology and traceability metadata as it goes. Weeks of manual SAS mapping and derivation become a governed, repeatable pipeline that regenerates cleanly on every data cut.
Point the agent at your EDC export or SDTM source and provide the study CRF annotations and mapping specification.
The agent generates SDTM domains, then derives ADaM datasets with controlled terminology and traceability metadata applied throughout.
Datasets are written to XPT, run through Pinnacle 21 conformance checks, and released with a findings report for programmer sign-off.
Capabilities
Maps collected data to interventions, events, findings, and special-purpose domains including DM, AE, LB, VS, EX, CM, and trial-design datasets.
Produces ADSL, ADAE, ADLB, ADEFF, and ADTTE with documented derivation logic and full one-to-one traceability back to SDTM.
Applies the correct CDISC CT version to every coded variable and flags non-conformant values before they reach validation.
Re-runs transformation rules against each new data transfer so datasets stay current without a full manual rebuild.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
Your third interim transfer arrives with new sites and updated labs. Instead of re-running SAS mapping by hand, the stored transformation and derivation rules refresh SDTM and ADaM incrementally, so ADSL and ADAE stay current for the next TLF run.
A coordinator entered a lab test not on the study's CDISC CT version. The agent flags the non-conformant value before it reaches Pinnacle 21, so you correct it at the data-management level instead of chasing a conformance finding at submission.
An FDA reviewer asks how an ADEFF endpoint was derived. Because every ADaM variable carries documented derivation logic and one-to-one traceability to its SDTM source, you point straight to the value-level metadata rather than reconstructing the logic weeks later.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Pinnacle 21
Validation
Who it's for
Generates complete, conformant Define-XML v2.1 metadata and the accompanying Reviewer's Guide directly from your SDTM and ADaM datasets.
Learn moreRuns Pinnacle 21 conformance validation on your SDTM and ADaM datasets and explains every finding in plain, actionable language.
Learn moreProduces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
