Agentic AI for clinical trials & eTMF
Your next trial is already behind before it starts. It doesn't have to be.
You know the grind — startup slipping week by week, work scattered across a dozen disconnected tools, the frantic scramble the month before an inspection, and never quite enough hands to do it all. Imagine walking in already ready instead: the study built, the data flowing, the file complete all along — with your team in control the whole way.
No pressure, no obligation — honest answers, including on the limits.
Built to 21 CFR Part 11 · ICH E6(R3) · CDISC · ISO 42001
Study build pipeline
Agent run queue
- Protocol IntelligenceComplete
- CRF DesignerComplete
- SDTM/ADaM DatasetRunning
- eTMF WorkflowQueued
Illustrative interface. Health1st AI is in pre-launch pilot; capabilities shown are planned.
Built for the regulators you answer to
- 21 CFR Part 11
- ICH E6(R3)
- CDISC (CDASH · SDTM · ADaM)
- HIPAA
- GDPR
- SOC 2
- ISO 27001
- ISO 42001
Sound familiar?
You're asked to move faster every cycle, with the same team and no room for a single audit finding.
- Startup keeps slipping — protocol to a built, ready-to-run database still takes months you don't have.
- Your team lives in a dozen disconnected tools, re-keying the same data and reconciling it by hand.
- The query backlog never really clears; someone is still closing discrepancies at 11pm before the cut.
- Then comes the pre-inspection scramble — chasing missing TMF documents six weeks out. Again.
And the part no one says out loud:
- That an inspector opens the one zone where a filing slipped through — and it's on your name.
- That the honest fix is more headcount you'll never get approved.
It doesn't have to be this way
Walk in already ready.
Health1st AI carries the repetitive build-and-file work so your experts spend their time on judgment, not busywork — every output grounded in your own documents, standards-aligned, and confirmed by a human before anything is final.
- Study startup measured in weeks, not quarters — with the controls intact.
- A Trial Master File that stays inspection-ready as you go, not the night before.
- Your people reviewing and signing off, never handing over control.
What changes for your team
Get your months back — without loosening a single control
The work that swallows study startup, data management, and reporting becomes agent-driven — grounded in your documents, standards-aligned, and reviewed by your people, so speed never costs you the audit trail.
- 70%
- less time from protocol to a built, ready-to-run database
- 37
- AI agents across the full trial lifecycle
- 30+
- languages for informed consent and site materials
- 250
- TMF artifacts filed across 11 reference-model zones
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Start where it hurts most
Wherever your study hurts most, there's an agent for it
Whichever stage is bleeding your time — building the study, wrangling the data, analyzing and reporting, or operating and archiving — a dedicated suite of AI agents takes the weight off, one job at a time.
Study Build & Design
7 agentsTurn a protocol into a ready-to-run study.
Read the protocol and build everything the study needs to launch — CDASH-compliant eCRFs and edit checks, informed consent in 30+ languages, SDTM annotations, and smart data-capture components. The foundation the rest of the trial is built on.
Explore the suiteData Management & Oversight
7 agentsClean data and continuous oversight, in real time.
Capture source data, surface every gap, and resolve queries automatically — while risk-based monitoring, adverse-event detection, and safety-signal management keep the study clean and inspection-ready as it runs.
Explore the suiteBiostatistics & Reporting
8 agentsSubmission-ready datasets, outputs, and reports.
Generate CDISC SDTM and ADaM datasets, Define.xml, and Tables, Listings & Figures that pass Pinnacle 21 clean — then draft ICH E3 clinical study reports and patient narratives, with predictive analytics on top.
Explore the suiteDocuments, Operations & Support
15 agentsA compliant eTMF and an AI project team.
Keep an inspection-ready electronic Trial Master File that auto-files and classifies itself to the TMF Reference Model, run project management and physician communication end-to-end, and give every user a fast, AI-triaged support desk.
Explore the suiteA few of the 37 agents
Hand off the jobs that eat your week
Each agent owns one specific job in the trial lifecycle — take on the one task that's hurting most today, or the whole platform when you're ready. You decide the pace.
Protocol Intelligence Agent
Digitizes any protocol and extracts its structure — objectives, eligibility, and the schedule of assessments.
Learn moreCRF Designer Agent
Turns a protocol into CDASH-compliant eCRFs with edit checks and validation rules.
Learn moreQuery Automation Agent
Runs the full query lifecycle — auto-populating responses, tracking status, and escalating by age, type, and priority.
Learn moreSDTM/ADaM Dataset Agent
Transforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreClinical Study Report (CSR) Agent
Assembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Learn moreeTMF Workflow Agent
A BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreFind the version of this that fits your role
Explore how Health1st AI maps to your organization and your role.
By organization
- Pharmaceutical SponsorsThe trial is behind before it starts. It doesn't have to be.
- Contract Research Organizations (CROs)Win on timelines you can actually keep.
- Research Institutions & SitesSponsor-grade rigor, without a sponsor-sized team.
- Emerging BiotechRun a credible first trial before you can staff one.
By role
- Clinical Data ManagersGet your time back from the keystrokes, and lock on time.
- Biostatisticians & Statistical ProgrammersSpend your time on the analysis, not the boilerplate.
- Medical WritersStart from a grounded draft, not a blank page.
- Clinical Operations & MonitorsSee the problems while they're still small.
- Regulatory Affairs & Quality AssuranceWalk into the inspection already ready.
- Clinical Project ManagersStop being the human tracking system.
- Safety & PharmacovigilanceNever be the one who missed the signal.
Works with the systems you already run
Medidata Rave
EDC
Oracle Clinical
EDC
Veeva Vault
EDC
IWRS / RTSM
IWRS/RTSM
Paddle OCR
OCR
Gemini / Anthropic LLM
LLM
Pinnacle 21
Validation
Email
Email
Meeting Notetaker
Meetings
WhatsApp Business
Messaging
Bidirectional sync keeps your EDC, IWRS/RTSM, validation tools, and document systems as the single source of truth. See all integrations →
What relief sounds like
The week you stop dreading the file
We are validating outcomes with early partners now, so this is the workflow we build toward — the kind of quiet an inspection-ready file gives a team. Verified customer stories and quantified case studies will appear here as pilots complete.
“By the time the inspection notice landed, there was nothing to scramble for — the TMF had been complete the whole way through. My nights and weekends were my own again.”
Illustrative — representative of the workflows we build toward during our pre-launch pilot.
Built for regulated trials
Compliance and security by design
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
21 CFR Part 11
Electronic records and signatures with full audit trails, access controls, and validation.
ICH E6(R3)
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
CDISC (CDASH · SDTM · ADaM)
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
HIPAA
PHI safeguards, de-identification, and role-based access across the platform.
GDPR
Lawful processing, data-subject rights, and EU data-residency support for global trials.
SOC 2
Security, availability, and confidentiality controls audited against Trust Services Criteria.
ISO 27001
Certified information-security management system governing the whole platform.
ISO 42001
AI management system for responsible, governed, and auditable use of AI.
Responsible AI · ISO 42001
You stay in control — every output, every model, every sign-off
Every agent is grounded in your source documents with retrieval-augmented generation, produces traceable and citable output, and requires human review and e-signature before anything is final. Our ISO 42001 AI management system governs how models are selected, monitored, and controlled across the platform.
Featured resource · Whitepaper
The State of AI in Clinical Trials
Where agentic AI is delivering measurable gains across study startup, data management, biostatistics, and TMF operations — and how to adopt it inside a validated, inspection-ready framework.
Whitepaper cover
State of AI in Clinical Trials
Frequently asked questions
Bring us the study that's keeping you up
No pitch, no pressure — a working walkthrough on your protocol, timeline, and compliance needs, with honest answers including on the limits. You leave knowing whether it fits, either way.