H1ST-AI-STAT-004 · Task 3.1
Hundreds of findings shouldn't be yours to decode
Before every data cut and submission, the validate-interpret-fix loop is the part you dread, and the part that eats your evenings. This agent runs conformance validation against CDISC and FDA rules, then triages the findings, separating true defects from expected explainable conditions and telling you exactly what to fix and where. The slow, iterative loop compresses into a report you can act on.
The grind you know
A Pinnacle 21 report drops hundreds of findings in your lap, and the real work isn't running it, it's deciding which are true errors, which are expected, and how to fix each one. Get that triage wrong and you either burn hours over-correcting benign findings or let a genuine conformance defect slip through to become an agency question with your name on it.
Part of the Statistical Programming family
SDTM/ADaM, Define.xml, TLFs & analytics.
Before every data cut and submission, the validate-interpret-fix loop is the part you dread, and the part that eats your evenings. This agent runs conformance validation against CDISC and FDA rules, then triages the findings, separating true defects from expected explainable conditions and telling you exactly what to fix and where. The slow, iterative loop compresses into a report you can act on.
Provide the SDTM or ADaM datasets and the define metadata to validate against the current rule set.
The agent runs conformance checks, then classifies each finding as a defect, an explainable condition, or noise.
It returns a report that explains every finding in context and recommends the specific remediation for each actionable item.
Capabilities
Runs the full CDISC and FDA rule set against SDTM and ADaM datasets and consolidates results into a single report.
Translates each rule ID into a plain-language description of the cause and the specific records affected.
Separates true defects from expected, explainable conditions and proposes documented justifications for the latter.
Recommends the concrete dataset or mapping change needed to clear each actionable finding.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
A Pinnacle 21 run returns 400 findings the night before a deliverable. The agent triages them into true defects, expected-explainable conditions, and noise, so you fix what matters instead of manually decoding every rule ID.
A rule fires because your study design legitimately produces that pattern. The agent drafts a documented justification you can drop into the Reviewer's Guide, rather than over-correcting a benign finding to make the report clean.
Buried among expected warnings is a genuine SDTM conformance error. The triage layer surfaces it with the specific records affected and a targeted remediation, so it doesn't slip through to become an agency question.
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 moreGenerates complete, conformant Define-XML v2.1 metadata and the accompanying Reviewer's Guide directly from your SDTM and ADaM datasets.
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.
