Solutions · Emerging Biotech
You have the molecule and the runway math, not a clinical operations department — yet. Health1st AI hands a small team an entire capability out of the box — build, data, biostatistics, and eTMF — so your first program looks and holds up like a seasoned sponsor's, without hiring every function first.
What you own
We know how this feels
This is the trial your company is riding on, and you're running it with a team small enough to fit in one room — every decision feels like it's yours alone.
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
Your whole study waits on one manual read
The agent on it
Protocol Intelligence AgentDigitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
The pain
Study build shouldn't swallow your timeline
The agent on it
CRF Designer AgentTurns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
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
Your CSR shouldn't be weeks of transcribing figures
The agent on it
Clinical Study Report (CSR) AgentAssembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
The pain
Your TMF shouldn't scare you before an inspection
The agent on it
eTMF Workflow AgentA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
The pain
Your weekly deck shouldn't be stale on arrival
The agent on it
Status Dashboard & Reporting AgentAutomated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
Your agentic workforce
These feature agents map most directly to emerging biotech. Enable the ones you need, per study and per deliverable, and expand over time.
Digitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
Learn moreTurns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Learn moreTransforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreAssembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Learn moreA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreAutomated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
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
“We're five people and one asset. This let us run a trial that stands up to diligence without hiring a department we couldn't afford yet — the deliverables look like they came from a company ten times our size.”
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 emerging biotech through exactly what stays under your control.
