Spot protocol deviations, safety lapses, and data-quality issues long before they become findings.
Spot protocol deviations, safety lapses, and data-quality issues long before they become findings.
Our AI-enhanced compliance engine continuously scans study data, protocol rules, and operational patterns—so teams intervene earlier, protect endpoints, and stay inspection-ready.
Early visibility of rising risks helps teams act before deviations spread across sites or affect endpoints. Sponsors shorten escalation timelines and reduce downstream cost by knowing where to intervene first.
Every flagged issue includes structured medical and operational reasoning — giving monitors the “why” behind the signal, accelerating triage, and ensuring defensible, inspection-ready documentation.
Built-in compliance tracking captures every decision, reviewer interaction, and audit action — ensuring your study remains aligned with ICH E6(R3) expectations and reducing inspection prep effort.
Issues are automatically grouped by underlying process drivers — revealing recurring root causes and enabling targeted corrections instead of repeated clean-up work.
Clear chronology shows when issues emerged, were detected, and updated — helping teams minimize detection latency, strengthen oversight, and prove timely risk response.
Harmonized filters unify operational, clinical, and data signals across all regions and partners. Teams see the same truth everywhere — eliminating fragmented oversight and improving cross-functional alignment.
Catch deviations in real-time, understand their drivers, and prevent impact on endpoints.
Early Detection That Protects Endpoints
Root-Cause Clarity for Targeted Correction
Inspection-Ready Traceability
Design out avoidable risk before FPFV. AI-augmented protocol analysis surfaces CtQs, quantifies complexity, predicts deviation hot-spots, and reduces amendment drag, so you lock in patient-safe, inspection-ready design from day one.
Operationalize RBQM with verifiable math. AI-guided RACTs, calculation transparency, RBAC-secured workflows, and cross-study analytics deliver proportionate controls, clear KRI/QTL governance, and faster, defensible decisions at scale.
Move beyond manual cleaning and fragmented reviews. With time-series anomaly detection, protocol-aware deviation checks, and structured reasoning, the MyRBQM® Portal highlights what truly requires attention.
Stay ahead of issues, not behind them. Portfolio-wide, AI-enhanced dashboards fuse KRIs, QTLs, and deviation signals to cut escalation latency and focus monitors on high-value actions, fully aligned with ICH expectations.
See the full patient story—fast. Subject Profiles synthesize visits, AEs, ConMeds, labs, and trendlines, accelerating case review and improving safety decisions with transparent traceability and RBAC-controlled access.
Fast, secure connectivity with your clinical platforms through ready-made endpoints and low-overhead, real-time or batch data sync.
Pre-engineered, validated connectors to major EDC systems — reducing integration time while enabling secure, real-time or scheduled data sync.
Seamlessly connect your enterprise data platforms with secure, governed, low-overhead sync — without restructuring your existing data lake.
Our platform and processes meet internationally recognized security, availability, and confidentiality standards. ISO 27001:2022 certification and SOC 2 examinations provide independently verified assurance of our information security controls.
Our clinical-grade AI is independently certified through Microsoft’s Healthcare AI program, ensuring transparent, human-guided oversight, responsible AI practices, and secure integration with Azure’s validated infrastructure.
The MyRBQM Portal is built in alignment with 21 CFR Part 11 and GAMP 5, ensuring data integrity, traceability, and suitability for use in regulated clinical research environments.
Move from reactive cleanup to proactive quality control with AI-driven signals and unified monitoring.
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