Support any RBQM operating model — while keeping governance, decisions, and traceability firmly in your hands.
Support any RBQM operating model — while keeping governance, decisions, and traceability firmly in your hands.
100%
Inspection-ready from Day 1
2–4x
Faster escalation response
60%
Up to 60% increase in signal visibility
Live oversight for every query, deviation and risk signal—ready for inspectors on day one.
Support global RBQM programs with restricted views for regions, partners, and functions. Define who sees which studies, KRIs, and signals — fully aligned with your governance model.
Instantly rank studies by risk, region, CRO, or lifecycle stage. Enterprise leaders get a real-time heatmap of where attention is needed across the entire portfolio.
Standardized visual signatures allow quick comparison across studies, CROs, or therapeutic areas — uncovering systemic risks early.
Regulatory, clinical, data management, biometrics, and quality teams access consistent, real-time insights — all mapped to the same risk logic.
Launch new studies with templates aligned to your global SOPs — ensuring consistent quality and eliminating CRO-to-CRO variability.
Trusted by large sponsors who keep RBQM governance internal while coordinating execution across multiple CROs and regions — with full traceability and portfolio-wide oversight.
Do you need RBQM that integrates with your existing enterprise stack?
Are you managing multi-region trials with high protocol complexity?
Do you require full customization to align with global SOPs?
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.
Download the guide to implementing enterprise-grade RBQM that connects with your tools, scales globally, and satisfies every regulatory body.
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