Solutions · Biostatisticians & Statistical Programmers
You trained for the statistical thinking — not for hand-cranking the 100th TLF shell or chasing a Define.xml finding at the last minute. Health1st AI generates CDISC SDTM and ADaM datasets, Define.xml, and TLFs that validate clean in Pinnacle 21, so your effort lands where your judgment actually matters.
What you own
We know how this feels
You spend your best hours on repetitive programming that any conformance check will grade pass/fail — while the analysis you're actually good at waits its turn.
And the part no one says out loud:
Where the agents fit
The grind you just read isn't abstract — each piece of it already has an agent assigned. Here's which one picks up which fight, so you can see exactly where the help lands before you commit to anything.
The pain
Every data cut shouldn't restart your mapping
The agent on it
SDTM/ADaM Dataset AgentTransforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
The pain
Define.xml shouldn't be the deadline scramble
The agent on it
Define.xml Generator AgentGenerates complete, conformant Define-XML v2.1 metadata and the accompanying Reviewer's Guide directly from your SDTM and ADaM datasets.
The pain
Hundreds of findings shouldn't be yours to decode
The agent on it
CDISC Validation AgentRuns Pinnacle 21 conformance validation on your SDTM and ADaM datasets and explains every finding in plain, actionable language.
The pain
The 100th TLF shouldn't be programmed by hand
The agent on it
TLF Generation AgentProduces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
The pain
You shouldn't learn the problem too late to fix it
The agent on it
Predictive Analytics AgentForecasts enrollment, retention, and outcome trends and surfaces early safety and efficacy signals through an explainable risk dashboard.
The pain
The blank page shouldn't cost you a week
The agent on it
Statistical Narrative AgentDrafts study and results narratives and executive summaries grounded in your actual TLFs and datasets, ready for statistician review.
Your agentic workforce
These feature agents map most directly to biostatisticians & statistical programmers. Enable the ones you need, per study and per deliverable, and expand over time.
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 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 moreForecasts enrollment, retention, and outcome trends and surfaces early safety and efficacy signals through an explainable risk dashboard.
Learn moreDrafts study and results narratives and executive summaries grounded in your actual TLFs and datasets, ready for statistician review.
Learn moreOutcomes
Quantified targets we build toward with each engagement.
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Every output is grounded, reviewed, and inspection-ready
“The standard datasets and shells come out P21-clean, so the finding that used to bite us after lock just isn't there. I finally spend my week on the study-specific analysis instead of the boilerplate everyone assumes is easy.”
Illustrative — representative of the workflows we build toward during our pre-launch pilot.
No pressure, straight answers
The doubts that usually surface before a team like yours says yes — answered plainly, including the places where the honest answer is a limit rather than a promise.
See it run on one of your own studies — no pressure, no obligation, and honest answers, including on the limits. We will walk biostatisticians & statistical programmers through exactly what stays under your control.
