AI-supported Subject Profiles unify AEs, labs, dosing, visits, and medical history into one traceable view—so your teams spot inconsistencies faster, prioritize high-risk subjects, and uphold patient safety with confidence.
AI-supported Subject Profiles unify AEs, labs, dosing, visits, and medical history into one traceable view—so your teams spot inconsistencies faster, prioritize high-risk subjects, and uphold patient safety with confidence.
AI highlights subjects with potential safety concerns, grades AE severity, and suggests next steps (clarify, verify dosing, follow-up labs). You confirm and record the call.
Delays, missed visits, and irregular patterns surface immediately—helping medical teams catch issues that affect dosing, eligibility, and subject safety before they escalate.
Longitudinal weight changes can indicate safety concerns or disease progression. Clear trends support faster medical judgment and defensible decisions in safety review boards.
Abnormal readings are highlighted so medical monitors can rapidly focus on outliers and initiate timely follow-up, reducing downstream deviations and safety escalations.
Temperature anomalies (e.g., fever spikes) are immediately visible, helping clinicians determine whether symptoms align with drug-related events, intercurrent illness, or data-entry issues.
Timestamped measurements provide the context needed for defensible medical decisions, ensuring all reviews are traceable, consistent, and audit-ready.
Switch between weekly, monthly, quarterly, or full-history views to understand whether issues are episodic or part of a long-term pattern—crucial for protocol deviation prevention.
Subject Profiles bring AEs, labs, dosing, and visits into one view.
See the Patients Who Need You Now
Understand Patterns, Not Just Events
Every Safety Call, Fully Traceable
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.
Speed up reviews while keeping medical rationale traceable and inspection-ready.
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