Enable your teams to use AI within GCP—supporting clinical trial execution while maintaining oversight, validation, and inspection readiness.
Enable your teams to use AI within GCP—supporting clinical trial execution while maintaining oversight, validation, and inspection readiness.
Designed for organizations introducing or scaling AI use in clinical trials—and needing clear, role-relevant guidance for safe and compliant application.
Clinical Operations & Study Teams
Apply AI within defined workflows for protocol review, study setup, and documentation—while maintaining control and traceability.
Medical Monitoring, Data & Central Monitoring
Support subject-level review, signal detection, and data oversight with AI—while maintaining clinical judgement, traceability, and controlled, auditable processes.
Quality, QA & Compliance Leadership
Establish a structured approach to AI use aligned with validation, inspection readiness, and regulatory expectations.
Shared terminology and essential RBQM logic for all contributors.
Apply AI within GCP-compliant workflows—supporting clinical tasks with defined controls, validation, and human 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.
Introduce AI into clinical workflows with clarity and control. This course equips your teams to apply AI in GCP environments.
Move from informal, individual use toward a consistent, organization-wide approach.
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