AI-supported protocol analysis that surfaces CtQs, quantifies complexity, and highlights deviation hot-spots early—helping teams secure cleaner designs and smoother study start-up while staying fully in control.
AI-supported protocol analysis that surfaces CtQs, quantifies complexity, and highlights deviation hot-spots early—helping teams secure cleaner designs and smoother study start-up while staying fully in control.
Watch AI analyze your protocol, flag risk drivers with interactive complexity scoring, and CtQ traceability.
Help teams align expectations early, plan resources appropriately, and ensure operational risks are identified before study startup.
Reduce manual interpretation, and ensure that key quality elements are captured consistently across studies.
Reduce time spent reviewing long documents and improve consistency across study teams.
Support more objective decision making and clear documentation for audits and inspections.
Give your teams defensible, data-backed protocol decisions that reduce rework, protect timelines, and strengthen inspection readiness from day one.
Clear Complexity Signals
CtQs Linked to Controls
Early, Explainable Risk Flags
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.
Get the essentials or walk through how CtQs become proportionate controls.
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