Governed AI for GxP and clinical operations. Built for validation and inspection readiness.
We deliver AI workflows for document heavy clinical, regulatory, safety, and medical operations. Outputs are traceable, reviewed when needed, and monitored in production.
Governed AI means
Governed AI means AI with audit logs, review steps, and monitoring.
- Outputs link back to sources when possible
- High-risk steps require human approval
- Quality is measured over time, not assumed
Where we help
- Regulatory content support (summaries, evidence extraction)
- Safety / PV narrative drafting support with citations to source pages
- Clinical operations documentation workflows
- Medical information / scientific content workflows
- Controlled knowledge retrieval for internal teams
Example output: a traceable summary of key findings and supporting citations for regulated documentation workflows.
What you get
Inputs include clinical reports, safety narratives, and regulatory packets. Outputs include traceable summaries, extracted evidence, and review queues. Impact: faster preparation with fewer manual handoffs.
- Reviewer ready outputs with citations and versioning
- Audit logs for inputs and outputs
- Validation-aligned evaluation harnesses
- Monitoring dashboards and change control workflows
Proof
Case study (anonymized): traceable regulatory evidence extraction and summarization for clinical operations.
Build something that passes scrutiny
Scope a pilot quickly and ship into production with governance built in.