Out-of-the-box oversight tools with the flexibility to configure to your unique needs without heavy IT lift.
Out-of-the-box oversight tools with the flexibility to configure to your unique needs without heavy IT lift.
4wks
RBQM Core live in 2–4 weeks
2×
Faster issue-to-action decision timelines
35%
Reduction in manual review cycles
Built-in risk libraries, key risk indicators, and inspection-ready controls—so you launch with confidence from day one.
Launch studies faster with preconfigured risk categories and templates based on industry standards—no heavy setup required.
Editable, version-tracked risk statements and scoring help maintain clear governance and audit-ready decision history—even in fast-moving studies.
Link risks to the right indicators immediately—reducing setup time and ensuring consistent oversight across CRO-supported studies.
Move from issue to action quickly with structured mitigation planning and automated reminders that keep teams aligned and responsive.
Give sponsors, CROs, and vendors the right level of access instantly—supporting hybrid oversight while keeping governance centralized.
Sort and group risks your way—no BI or custom dashboards required. Perfect for lean teams and rapid reviews.
Trusted by biotech and mid-size pharma teams who need fast RBQM deployment, clear governance, and inspection-ready traceability while working in hybrid delivery models.
Do you want RBQM tools ready to use with light configuration?
Are you looking to scale oversight without the complexity of full enterprise systems?
Is rapid onboarding a priority for your upcoming studies?
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 lean, compliant RBQM that fits your team, budget, and study pipeline.
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