Equip your study leads and operational teams with applied RBQM skills—anchored in real clinical data and aligned with ICH E6(R3)—to drive confident, inspection-ready decision-making across your portfolio.
Equip your study leads and operational teams with applied RBQM skills—anchored in real clinical data and aligned with ICH E6(R3)—to drive confident, inspection-ready decision-making across your portfolio.
Advance RBQM capability across the teams responsible for designing, steering, and safeguarding your studies — with role-relevant, real-world practice that translates directly into operational oversight.
RBQM Leads, Study Managers & Operational Decision-Makers
Equip those who drive trial execution with the skills to interpret signals, validate risks, and steer study teams using defensible, inspection-ready evidence.
Data Management & Central Monitoring Functions
Strengthen analytical capability with hands-on practice using real clinical datasets — improving prioritization, escalation decisions, and cross-functional collaboration.
Medical Monitors, Safety Teams & Clinical Scientists
Support safety-critical roles with structured methods to detect, evaluate, and communicate emerging risks — enhancing patient protection and documentation quality.
Shared terminology and essential RBQM logic for all contributors.
Translates principles into hands-on design, risk evaluation, and data-driven oversight using real study data.
For senior leads seeking advanced decision leadership, governance design, and end-to-end QbD/RBQM stewardship.
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.
Strengthen oversight maturity across study teams. Green Belt moves contributors beyond terminology into hands-on application.
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