Sustainable QbD and RBQM adoption grows from shared language and aligned decision logic. The White Belt builds that common foundation — reducing friction, speeding adoption, and reinforcing inspection-readiness from day one.
Sustainable QbD and RBQM adoption grows from shared language and aligned decision logic. The White Belt builds that common foundation — reducing friction, speeding adoption, and reinforcing inspection-readiness from day one.
Build a shared RBQM foundation across functions, so teams speak the same language and execute oversight consistently.
Anyone entering RBQM
Gives new team members the baseline vocabulary and logic needed to engage confidently in QbD, risk assessment, and oversight discussions.
Sponsors & CRO teams preparing for rollout
Helps organizations align cross-functional contributors before adopting RBQM — reducing friction and speeding up implementation.
Clinical staff building terminology confidence
Ensures CRAs, site-facing teams, and central monitors understand RBQM terms and decision cues — strengthening day-to-day oversight.
Essential RBQM awareness for all contributors.
From terminology to applied oversight.
Industry’s reference standard for RBQM training.
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.
Create alignment from day one. White Belt lays the groundwork for confident RBQM adoption across clinical, data, and operational teams.
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