For Clinical Operations Teams
Governed AI agents for trial back office, eCRF, and regulatory.
Deploy AI agents across Medidata, Veeva, Oracle Clinical, and your CTMS — with PHI redacted before any external LLM sees it, EDC write-paths gated by policy, and every action logged for 21 CFR Part 11.
For Clinical Operations Teams
Three clinical jobs, off your team's plate
The work that fills a study coordinator's week — and the work that breaks when an ungoverned agent touches subject data. ContextGate makes it safe to automate.
Trial back office
Manage trial documents, resolve site queries, draft site communications, track protocol deviations — and surface anything that needs the CRA before it becomes a finding.
eCRF data assistance
Prep eCRF forms from source documents, resolve edit checks, support source data verification — with every suggested entry traceable back to the source line.
Regulatory submission prep
Gather study artefacts, redact PHI to ICH-GCP standards, format and cross-reference per submission template, surface gaps before the regulatory affairs lead opens the package.
Why ContextGate
Why clinical leaders pick ContextGate
An AI agent with access to subject data is one bad prompt away from a finding at the next sponsor audit. ContextGate puts policy, redaction, and audit in front of every call.
PHI redacted, HIPAA-aligned
Subject identifiers, dates of birth, MRNs, and free-text clinical notes are stripped before the prompt leaves your workspace. The model reasons over de-identified records.
EDC write-paths gated
Form submissions, query closures, and protocol-deviation entries require explicit policy approval. Source data verification stays with the human. No silent eCRF writes.
21 CFR Part 11-ready audit
Every agent action — which subject, which form, which field, which approver, which timestamp — logged with full request/response. Map straight to your validation evidence.
EDC tool sprawl, contained
Medidata, Veeva, Oracle Clinical, and CTMS systems each ship dozens of MCP endpoints. Toolboxes only expose what each agent needs — prompts stay lean and validated.
Get in Touch
Ready to govern your AI agents? Let us know about your use case and we'll help you get started.