Arbiter provides an AI‑assisted Institutional Review Board (IRB) platform that streamlines protocol intake, review, and decision making for research institutions. The system automatically reads submissions, predicts the appropriate review category, and checks for regulatory compliance against 45 CFR 46, 21 CFR 50/56, and the Common Rule, while maintaining an immutable audit trail and role‑based access controls. It also generates draft determination letters and renewal reminders, reducing manual email follow‑ups and improving consistency across reviewers.
Funding
Funding not disclosed
Founders
Product
Problem
Human‑subjects research reviews are often hampered by fragmented communications, manual document handling, and inconsistent interpretation of federal regulations, leading to delays, compliance gaps, and extensive email back‑and‑forth.
Solution
Arbiter offers an AI‑assisted Institutional Review Board (IRB) platform that centralizes protocol intake, automates regulatory categorization, and surfaces compliance issues before review. Investigators submit full protocols through a guided portal; the system reads the documents, predicts the appropriate review category (exempt, expedited, or full board), and flags missing or non‑conforming elements against 45 CFR 46, 21 CFR 50/56, the Common Rule, and institutional policies. Reviewers receive structured evaluations with draft determination letters that cite specific regulatory criteria, while the platform logs every action in an immutable, append‑only audit trail with role‑based access controls. Automated renewal reminders and unified discussion threads eliminate reliance on email and disparate file stores, providing a single source of truth for IRB workflows.
Target Audience
Primary customers are research institutions, universities, and hospitals that operate an IRB and need a secure, compliant system to manage human‑subjects protocol reviews.
Features
- Guided submission portal that ingests full protocols and supporting documents
- AI engine trained on 45 CFR 46, 21 CFR 50/56, the Common Rule, and institutional policies to predict review category and detect compliance gaps
- Pre‑review compliance checks with explanations and direct references to the relevant regulation
- Immutable, append‑only audit trail with strict role‑based access and SOC 2‑ready security
- Unified conversation threads linking attachments, reminders, and reviewer comments to each submission
- Automated generation of determination letters and renewal reminders
- MFA‑ready authentication and encryption at rest with US‑East data residency