Features

Everything an IRB office actually does, in one workspace.

Submission intake, reviewer workflow, board meetings, determination letters, lifecycle tracking, audit trail. Each one specific, each one cited.

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Submission & intake

Every protocol, every consent form, every version — searchable.

Upload PDFs and DOCX. Version with change notes. See word-level redlines between any two versions. Stop emailing protocol_v3_FINAL_REALLY.docx around.

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Word-level redlines between any two versions.

Pick any prior version of a consent form or protocol. See the diff against the latest in green and red — no more squinting at Word's tracked changes.

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Reviewer workflow

Catch reviewer conflicts before assignment, not at the meeting.

Auto-flag same-department, same-PI, and prior-collaborator conflicts the moment a reviewer is assigned. No more last-minute recusals derailing the agenda.

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Board meetings

Run the convened review without spreadsheets.

Schedule a meeting, agenda auto-builds from the queue, quorum is verified live, outcomes per agenda item generate determination letters with cited regulations. Minutes are inline.

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Study lifecycle

Continuing reviews that stop slipping through.

Auto-tracked CR due dates with 60/30/14-day reminders. Expiration warnings before approval lapses. Visible in the IRB Director dashboard at a glance.

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AE deadlines tracked the way the regulations specify.

Severity-aware reporting deadlines per OHRP and 21 CFR 312.32. Real-time countdown on the dashboard. No more deadline calculations on the back of an envelope.

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Compliance & audit

Inspection-ready evidence, one click away.

Every mutation logged with actor, timestamp, resource, and IP hash. Filter by action, user, or study. Export to CSV for an OHRP visit, an FDA inspection, or an AAHRPP accreditation review.

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AI assistance

AI that cites the regulation, not its imagination.

Engine-resolved IRB pathway with citations to §46.x, §164.x, 21 CFR 50/56, and OHRP guidance. AI rationale paragraphs with citation guards that block fabricated CFR sections. Built for compliance.

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