QMENTA launches Central Review for FDA real-time imaging trials

QMENTA on June 23 launched Central Review, a single system for imaging trial review, adjudication and export as sponsors adapt to the FDA’s real-time clinical trials push. The platform is designed to reduce longitudinal inconsistencies in long oncology and CNS studies, where late reader changes can quietly distort results.

Why it matters: - The FDA’s Real-Time Clinical Trials initiative pushes imaging trial errors into the financial and operational spotlight as soon as they happen. - Long-duration oncology and CNS studies are especially exposed to reader turnover, inconsistent longitudinal reads, and late discovery of quality failures. - QMENTA is positioning Central Review as infrastructure built for that pressure, not as a back-end cleanup tool.

What happened: - QMENTA announced Central Review on June 23, 2026. - Central Review is an end-to-end platform for site upload, blinded multi-reader assessment, adjudication, QA, and locked database export. - The system is built as a single 21 CFR Part 11-compliant workflow. - The announcement was made in Boston.

The details: - Central Review links every scan across all timepoints for each subject. - A longitudinal electronic Case Report Form is available as a single table. - Users can export the eCRF to PDF with one click, and the export is fully audit-trailed. - Sites can upload through a browser, Python SDK, or direct PACS connector. - Automated de-identification is built in. - Reader blinding is enforced through role-based access and dedicated worklists. - Adjudication is built into the workflow, and every event is captured in the audit trail. - QMENTA’s platform inherits 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, ISO 13485, and GxP compliance. - The broader QMENTA Platform holds FDA 510(k) clearance. - QMENTA says the platform has had zero nonconformities across external pharmaceutical partner audits.

Between the lines: - The pitch centers on longitudinal consistency, not just reader capacity. - That matters because a reader who joins a study years later may not manually re-check every prior scan, which can introduce drift across timepoints. - The company is arguing that software should surface prior studies and response-criteria context automatically so readers do not have to reconstruct the patient history themselves. - The compliance stack and audit trail are aimed at making the system defensible to regulators, not just usable for trial teams.

What's next: - QMENTA will host a live webinar on June 25, 2026 at 12:00 PM ET. - Dr. Aly H. Abayazeed and Paulo Rodrigues, PhD, will demonstrate subject-linked reads and longitudinal eCRF export. - Registration is available through the webinar page. - QMENTA is also offering a two-month trial with free cloud credits at QMENTA.

The bottom line: - QMENTA is betting that real-time imaging trials need a fully auditable, longitudinal review system, not a patchwork of separate tools and manual handoffs.