AI-augmented detection and mitigation insights that help teams see more, decide faster, and stay in control.
AI-augmented detection and mitigation insights that help teams see more, decide faster, and stay in control.
AI-supported RACT surfaces key risks, complexity indicators, and mitigation priorities — giving your teams a faster, clearer starting point for QbD-aligned decisions.
AI consolidates protocol insights, detects risk patterns, and highlights mitigation priorities—so teams move faster from identification to documented control actions, while staying firmly in command of final decisions.
RACT auto-breaks each risk into its drivers and potential impacts, reducing manual interpretation effort and ensuring every study team starts with the same structured understanding.
Supports more consistent, defensible scoring across functions. AI flags scoring outliers and provides relevant context so decision-makers evaluate risks objectively and document choices transparently.
AI generates mitigation actions aligned with Good Clinical Practice and sponsor SOPs—speeding up action planning while keeping medical, operational, and regulatory judgment entirely human-controlled.
RACT ensures clinical, data, safety, and operational teams work from one synchronized risk record—reducing friction and accelerating agreement on responsibility, timelines, and controls.
All decisions, scores, and AI-generated suggestions are captured with a full audit trail—supporting inspection readiness and reducing back-and-forth during regulatory or QA reviews.
AI augments the assessment, giving teams broader insights, more consistent scoring, and faster agreement on the controls that keep studies safe and inspection-ready.
Centralized, Audit-Ready Risk Assessment
Indication-Specific Risk Libraries
AI-Assisted Mitigation Drafting
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.
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