What an agent does here

Reading and checking, not deciding

An agent is given a task, the relevant documents, and your standards. It works through the task step by step: it retrieves what it needs, analyzes it, and drafts a result with its reasoning and the sources it used.

The agent never has the final say. It proposes, and a qualified person reviews and approves before anything is used. The value is in the hours of reading it removes, not in replacing judgment.

How we keep it safe

  • Human in the loopAgents propose; your people review and decide.
  • Runs in your environmentYour data stays inside your validated infrastructure.
  • TraceableEvery step and source is recorded for audit.
  • ValidatedQualified like any other tool used in GxP work.

Featured agent

The agents we build

Each one is scoped to a specific task, grounded in your data and standards, and reviewed by a person before its output is used.

Protocol Review Agent

Checks a draft protocol for consistency, completeness, and alignment between objectives, endpoints, and criteria.

SDTM Mapping Agent

Proposes mappings from collected data to SDTM domains, with the reasoning behind each, for a programmer to confirm.

Specification Agent

Drafts dataset specifications and define.xml, then cross-checks them against the actual data for mismatches.

Output QC Agent

Compares tables, listings, and figures against their specifications and flags anything that does not match.

Safety Narrative Agent

Drafts patient safety narratives from structured data for a medical writer to review and finalize.

Literature Surveillance Agent

Scans published literature on a schedule and summarizes possible pharmacovigilance signals for assessment.

Submission Readiness Agent

Checks a submission package against structural and standards requirements before it goes to a health authority.

Data Query Agent

Reviews study data for discrepancies and drafts queries for data management to confirm and send.

How an agent works

The same dependable pattern sits behind every agent.

1

Ground

The agent is given your documents, data, and standards to work from.

2

Work

It plans and runs the task in steps: retrieve, analyze, and draft.

3

Record

Every action and source is logged so the result can be traced.

4

Review

A qualified person checks and approves before the output is used.

Built for a regulated setting

Agentic tools only belong in clinical work if they meet the same bar as everything else.

Oversight by design

Agents act within defined boundaries and permissions, and a person signs off on anything that leaves the system.

Your data stays yours

Agents run inside your environment. Clinical and patient data is not sent to outside services.

Explainable output

Every finding carries its source and the steps behind it, so reviewers can check the reasoning, not just the answer.

Start with one agent on one task

Tell us where your team spends hours reading and checking. We will scope an agent for it and prove the value before going further.

Talk to our team