The platform
The EDC, the CTMS, the coding tool, the statistical environment, a separate eTMF — every handoff between them is a place the timeline slips and something falls through the cracks. Health1st AI closes those gaps into one connected system: thirty-seven specialized AI agents build your eCRFs and consent, clean your data, generate submission-ready CDISC datasets and reports, and keep a compliant eTMF — all grounded in your documents, with your team in control, and governed under ISO 42001.
Protocol → inspection-ready study
Built for regulated trials — aligned to the standards inspectors expect
The whole trial, on one platform
Instead of stitching together an EDC, a CTMS, a coding tool, a statistical environment, and a separate eTMF, Health1st AI runs the full value chain as one connected, agentic system.
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Across the lifecycle
Each stage of the trial hands clean, structured context to the next. The agents share one data model, so nothing is re-keyed and nothing falls through the cracks.
Protocol Intelligence digitizes the protocol and schedule of assessments, turning a PDF into structured, machine-readable study design.
CDASH-compliant eCRFs, edit checks, informed consent in 30+ languages, and SDTM annotations are generated so the study is ready to capture data.
Source data is extracted, gaps and queries are resolved automatically, and risk-based monitoring surfaces adverse events and safety signals in real time.
SDTM and ADaM datasets, Define.xml, and Tables, Listings & Figures are produced and validated clean in Pinnacle 21.
ICH E3 clinical study reports and patient narratives are drafted from the SAP and statistical outputs, with a human author always in control.
Every essential document classifies and files itself to the TMF Reference Model, keeping a complete, contemporaneous eTMF ready for inspection.
Wherever your study hurts most
Under the hood, the 37 agents are grouped into four value-chain suites, each holding one or more agent families — the specialized systems that do the work. Start with the single agent that solves your worst bottleneck, or run them together as one platform. The choice is yours.
Turn 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.
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 moreGenerates ICH-GCP-compliant informed consent forms at an 8th-grade reading level.
Learn moreTranslates informed consent into 30+ languages with back-translation verification.
Learn moreEdit CRFs, validations, and ICFs with natural-language instructions — like ChatGPT for study build.
Learn moreAuto-generates SDTM annotations and the annotated CRF, Pinnacle 21-clean.
Learn moreAI-prompted, accessible data-capture components — sliders and scales for subjective assessments.
Learn moreClean 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.
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Source-document extraction & query automation.
Turns source documents into clean, complete data. Clinical Data Capture extracts values, detects missing or inconsistent information, and drives the query lifecycle from generation to resolution.
Explore Clinical Data CaptureH1ST-AI-MON-003
Risk-based monitoring & safety oversight.
Continuous, centralized oversight. Risk-Based Monitoring reviews source documents, detects symptoms and adverse events, surfaces safety signals, and tracks key risk indicators against ICH E6(R3) thresholds.
Explore Risk-Based MonitoringExtracts structured trial data from source documents with OCR and clinical NLP, de-identifying PHI as it reads.
Learn moreCompares submitted data against expected fields to find gaps, then generates context-aware queries to close them.
Learn moreRuns the full query lifecycle — auto-populating responses, tracking status, and escalating by age, type, and priority.
Learn moreReads source documents with OCR and clinical NLP to surface review findings, each with a confidence score.
Learn moreRecognizes symptoms and adverse events in clinical notes and prompts the right assessment before they're missed.
Learn moreAggregates events across sites to detect safety signals and suggests medical coding for faster review.
Learn moreRuns configurable monitoring rules and Key Risk Indicators, surfacing findings on a severity-ranked dashboard.
Learn moreSubmission-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.
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SDTM/ADaM, Define.xml, TLFs & analytics.
The biostatistics workhorse. Statistical Programming builds submission-ready CDISC datasets and Define.xml, validates them clean in Pinnacle 21, generates Tables/Listings/Figures, and adds predictive analytics and automated narratives.
Explore Statistical ProgrammingH1ST-AI-MWR-005
ICH E3 CSRs & patient narratives.
Regulatory writing at draft-speed. Medical Writing assembles ICH E3 clinical study reports and patient safety narratives from the protocol, SAP, and statistical outputs — with a human author always in control.
Explore Medical WritingTransforms 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 moreAssembles ICH E3-structured Clinical Study Reports that pull results directly from your TLFs and datasets, with full track-changes review support.
Learn moreDrafts and refines patient safety narratives into consistent, regulation-aligned wording with full version control across the narrative set.
Learn moreA 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.
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An eTMF that files and manages itself.
An inspection-ready electronic Trial Master File built on the TMF Reference Model v3.3.1 (250 artifacts across 11 zones). eTMF & Documents classifies, auto-files, routes, e-signs, and version-controls every essential document.
Explore eTMF & DocumentsH1ST-AI-PM-007
Action items, status, deviations & comms.
The AI program manager. Clinical Project Management extracts action items from email, keeps study and site status dashboards current, tracks protocol deviations and CAPAs, reviews safety, and runs site and physician communication.
Explore Clinical Project ManagementH1ST-SUP-TKT-001
AI-triaged help desk for every user.
The support system behind the platform. Study Support Desk handles issue intake and tracking, manages SLAs, powers a self-service knowledge base, and uses AI to classify and prioritize every ticket.
Explore Study Support DeskA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreAn AI classifier that reads clinical documents and assigns the correct TMF zone, section, and artifact with extracted metadata.
Learn moreAn intelligent dump-folder that auto-assigns metadata and files documents to the correct TMF location behind a review-and-approve gate.
Learn moreA review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
Learn moreDocument version control with change tracking, side-by-side comparison, and controlled archive management for the TMF.
Learn moreAn AI agent that reads project email and meeting notes to extract action items, assign owners, and track them to closure.
Learn moreAutomated study and site status dashboards with executive summaries, KPIs, and threshold alerting.
Learn moreProtocol-deviation tracking and categorization with integrated CAPA management aligned to ICH E6.
Learn moreSAE and SUSAR tracking with automated reconciliation between the EDC and the safety database.
Learn moreAutomated site emailers for milestones, reminders, and status, plus periodic study newsletter generation and distribution.
Learn moreA consented, compliant-channel WhatsApp workflow for physician and site-team notifications, response capture, and AI-driven next steps.
Learn moreA ticketing system for users to submit, track, and resolve platform issues across the study team.
Learn moreResponse and resolution time tracking with automatic escalation against defined service-level agreements.
Learn moreA self-service FAQ and troubleshooting library powered by retrieval-augmented (RAG) search.
Learn moreAI-based ticket prioritization and routing that assigns urgency and directs each issue to the right team.
Learn moreGrounded in your study, not the open web
That confidence comes from a custom clinical language model paired with a retrieval-augmented generation layer: every agent grounds its work in the actual protocol, standards, and source data — not generic web text — so what it produces can be checked against where it came from.
A language model fine-tuned on clinical-trial artifacts — protocols, CRFs, CDISC standards, ICH guidelines, and regulatory templates — and hosted on Google Cloud. It understands the vocabulary, structure, and conventions of clinical research, and works alongside Gemini and Anthropic frontier models for the tasks each does best.
Retrieval-augmented generation indexes your study's documents and structured data, then grounds every answer and generated artifact in the specific passages it retrieved. That means traceable citations, fewer hallucinations, and outputs an auditor can follow back to source.
Want the detail on grounding, human review, and AI governance? See how it works.
Dashboards & analytics
Real-time dashboards roll up the work every agent is doing into the operational and quality metrics sponsors, CROs, and sites actually manage against.
Track the path from protocol to first-patient-in — build status, site activation, and consent readiness across every site.
Enrollment, query rates, data-entry lag, and protocol-deviation trends, ranked so under-performing sites surface early.
Key performance and risk indicators tracked against ICH E6(R3) thresholds for continuous, risk-based oversight.
Monitoring of FDA 483 observations and debarment lists to flag inspection and investigator risk before it becomes a finding.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Medidata Rave
EDC
Oracle Clinical
EDC
Veeva Vault
EDC
IWRS / RTSM
IWRS/RTSM
Paddle OCR
OCR
Gemini / Anthropic LLM
LLM
Pinnacle 21
Validation
Meeting Notetaker
Meetings
WhatsApp Business
Messaging
From EDC and IWRS/RTSM to OCR, LLM providers, email, and validation tools, Health1st AI fits into your existing stack with bidirectional sync. Explore all integrations.
Book a walkthrough and we'll show how the agents build, run, and archive a study end-to-end — grounded in your documents.
