H1ST-AI-STAT-004 · Task 3.1
Define.xml shouldn't be the deadline scramble
The define shouldn't be the thing that keeps you at your desk the week before submission. This agent reads your dataset metadata and derivation specifications to assemble a Define-XML v2.1 document with variable-level, value-level, and computational-method metadata fully populated. The manual, deadline-driven scramble of authoring define.xml and its Reviewer's Guide becomes a draft you review instead of build from scratch.
The grind you know
Define-XML is required for your FDA and PMDA submissions, yet it lands on you at the very end, when you are already stretched thin and the clock is loudest. You have seen where it bites, missing value-level metadata, an undocumented computational method, a define that no longer matches the datasets you shipped, and each one comes back as rework or an agency question you have to answer.
Part of the Statistical Programming family
SDTM/ADaM, Define.xml, TLFs & analytics.
The define shouldn't be the thing that keeps you at your desk the week before submission. This agent reads your dataset metadata and derivation specifications to assemble a Define-XML v2.1 document with variable-level, value-level, and computational-method metadata fully populated. The manual, deadline-driven scramble of authoring define.xml and its Reviewer's Guide becomes a draft you review instead of build from scratch.
The agent reads your SDTM and ADaM datasets along with their mapping and derivation specifications.
It builds the Define-XML v2.1 structure, populating variable-level, value-level, and computational-method metadata.
The define and Reviewer's Guides are produced, then reconciled against the datasets with any mismatches reported for review.
Capabilities
Produces standards-compliant metadata for SDTM and ADaM, including datasets, variables, codelists, and where-clauses.
Derives value-level metadata and computational method definitions from your derivation specifications automatically.
Generates the SDRG and ADRG with data-flow narrative, conformance summary, and documented deviations.
Cross-checks the define against the actual datasets so declared metadata always matches what was shipped.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
It's the last week before submission and the define still isn't done. The agent reads your dataset metadata and derivation specs to assemble a Define-XML v2.1 document with value-level and computational-method metadata populated, so you review a draft instead of authoring one from scratch.
A late data cut alters an ADaM codelist. Reconciliation cross-checks the define against the shipped datasets and reports the mismatched where-clause, so the define you submit matches the data you actually shipped.
You need both Reviewer's Guides for FDA and PMDA. The agent generates the SDRG and ADRG with data-flow narrative and a conformance summary, giving your regulatory team a starting document rather than a blank template.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Pinnacle 21
Validation
Transforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreRuns Pinnacle 21 conformance validation on your SDTM and ADaM datasets and explains every finding in plain, actionable language.
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.
