ONIX is not an AI overlay on an existing PACS. It is a ground-up workflow engine designed for the specific compliance, data, and operational requirements of regulated clinical research.
Built from the ground up for regulated clinical imaging — not retrofitted from a radiology PACS.
Every scan is validated against the trial's imaging charter before a clinician opens it — catching protocol deviations at the source. ONIX AI checks imaging parameters, series completeness, and compliance requirements automatically.
Subspecialty assignment by modality, indication, and reader workload. Blind dual-assignment for BICR with automatic adjudication trigger on concordance failure. Priority escalation via AI-scored urgency flags.
Ensures the right reader receives the right case at the right time — without manual coordinator bottleneck.
The clinician dictates naturally. ONIX auto-extracts lesion dimensions, classifies and populates target/non-target fields, exports HL7/eCRF-ready structured data.
Dramatically reduces per-read reporting time — and on a 1,000-read trial, saving compounds significantly across the study.
Blinded independent central review orchestrated end-to-end. Dual-read assignment, concordance detection, automatic adjudication trigger, third-reader assignment. All events timestamped and cryptographically signed in the audit trail.
Every read event — upload, QC check, assignment, read, query, sign-off — is cryptographically timestamped in an append-only chain. Designed, operated and maintained in alignment with 21 CFR Part 11, ICH and GAMP 5 requirements.
ONIX AI™ is built on open standards and integrates with any hospital PACS, any eCRF system, and any third-party algorithm via standard APIs. If you already have imaging infrastructure in place, ONIX is designed to integrate with it.
QC protocols, measurement standards, and report structure are enforced by ONIX AI™ on every read. But credentialed clinicians remain the final signatory on every read event. This is not an automated reporting system — it is an AI-powered platform that makes clinicians faster, more consistent, and audit-ready.
This governance model is designed specifically for GCP and 21 CFR Part 11 environments, where human accountability is a regulatory requirement — not a design choice.
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