Risk Based Quality Management

Comprehensive AI Driven Risk & Quality Management

Slash Central Monitoring Effort by 60% with Agentic AI and Outcome-Driven RBQM.

Let Agentic AI draft your Risk Plan in hours—not days—by analyzing the protocol to extract Critical-to-Quality (CtQ) factors, identify risks, recommend impactful mitigations, and apply tailored risk scoring based on study context
Deploy monitoring strategies faster with AI-recommended KRIs, QTLs, and data-driven triggers. Agentic AI auto-configures thresholds and alerts aligned to CtQ factors, enabling continuous protection throughout the trial

Access real-time data at every level—from strategic and operational to analytical and self-service—with our suite of Key Risk Indicators (KRIs), Key Performance Indicators (KPIs), Quality Tolerance Limits (QTLs), and dynamic dashboards
Harness advanced ML-driven predictive analytics to surface insights, including the likelihood and timing of potential QTL breaches, enabling proactive interventions
Easily create and customize data models, visualizations, and dashboards in an agile, governed environment — delivering both flexibility and rigorous quality control

Let AI agents surface emerging anomalies and cross-domain patterns, proactively recommending the next best action—so teams can respond faster and with greater precision
Never miss a critical risk review—automatically alert end-users to safety and quality issues with timely, data-driven triggers
Apply cadence-based triggers or tap into our extensive library of pre-configured, data-driven triggers to stay compliant and ahead of risks

Use an intuitive, easy-to-navigate interface to manage both risk and data review workflows, ensuring complete traceability across your clinical trials
Whether you use our pre-configured workflows or customize your own, seamlessly fit the platform to meet your organizational roles and processes
Enable email alerts to notify users of assigned actions, ensuring timely follow-ups without needing to log into the platform

Unlock the Potential of Unified Clinical Data with ThoughtSphere!