Health1st AI Logo

Data Management & Oversight · H1ST-AI-DEN-002

Clinical Data Capture

Source-document extraction & query automation.

The problem this family owns

When source-document extraction & query automation is left to manual work

This is the stretch of the trial where the work is repetitive, deadline-bound, and unforgiving of small errors — the part a stretched team feels first, and the part where a missed detail is most expensive to fix later.

The Clinical Data Capture family puts a purpose-built agent on each of these. You stay in control of every output — the agents absorb the grind, not the judgment.

Where it fits

The Clinical Data Capture family in the trial lifecycle

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.

It sits in the Data Management & Oversight suite — clean data and continuous oversight, in real time — and is delivered as 3 individually-deployable AI agents you can adopt one at a time or as a complete workflow.

The agents

3 agents in the Clinical Data Capture family

Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.

One workflow, not point tools

How these agents work together

Enabled together, the Clinical Data Capture agents hand off in sequence — each one's output becomes the next one's input, so nothing is re-keyed and nothing falls between the seams.

  1. 1
    Source Data Extraction Agent

    Extracts structured trial data from source documents with OCR and clinical NLP, de-identifying PHI as it reads.

  2. 2
    Missing-Information Detection Agent

    Compares submitted data against expected fields to find gaps, then generates context-aware queries to close them.

  3. 3
    Query Automation Agent

    Runs the full query lifecycle — auto-populating responses, tracking status, and escalating by age, type, and priority.

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.

Straight answers

Common questions about the Clinical Data Capture family

Pulled from the questions teams ask most about the agents in this family — answered plainly, including where the honest answer is a limit.

See the Clinical Data Capture family on your study

No pitch, no pressure — a working walkthrough on your own workflow and honest answers, including on the limits. Bring the study that worries you most.