RBQM-ai risk-based quality management

RBQM-ai is an evidence-first clinical-trial oversight workspace for qualified professionals. It combines central monitoring, site prioritisation, governed KRI and QTL surveillance, data lineage and secure operational communication. Its analyses support human judgement and do not make clinical decisions.

Evidence-led trial oversight

Analytical outputs retain their study, accepted data cut, source provenance, method, configuration, freshness and uncertainty context. Missing or unqualified evidence remains visible instead of being presented as a result.

Therapeutic and device intelligence

Therapeutic Intelligence Pro searches 106,825 clinical studies and 1,495,106 traceable evidence assertions. It explains comparable-study relevance, synthesises reported outcomes and operational failure modes, and ranks reviewable CtQ, risk, KRI, QTL and mitigation candidates with uncertainty.

Device Intelligence Pro connects 7,004 device studies and 119,891 study assertions with 5,500,161 official AccessGUDID, FDA and EUDAMED reference records. It adds device classification, product-code, UDI, PMA, 510(k), recall, operator, procedure, software and malfunction context without presenting report frequency as incidence.

Both Intelligence Pro products turn matched historical evidence into a human-reviewed prior bundle, executive and technical RBQM dossiers, and an attributable reviewer learning loop before evidence enters the governed Core.

Sixteen-step governed RBQM workflow

Follow the interactive 16-step RBQM workflow from study understanding, RACT and qualified data through CMP, SPOT, controlled action, QTL forecasting and complete report export.

Human-controlled and security-conscious

Consequential monitoring actions require authorised human review. Public pages contain no participant or operational study data. Learn about security, data protection and the terms of use.