RISK-BASED QUALITY MANAGEMENT (RBQM)

AI-Powered Clinical Trial Management & Documentation

CluePoints ensures that all risk-related activities, decisions, and outcomes are recorded accurately, comprehensively, and automatically within a centralized platform equipped with advanced statistics and machine learning. Users leverage RBQM for immediate review and action, mitigating potential risks, and securing the safety and efficacy of trials.

DOCUMENTATION

Risk Assessment & Mitigation

Risk assessments help users identify vulnerable trial areas, define risk controls, and monitor capabilities to detect evolving threat levels during study execution. Equipped with a complete audit trail, CluePoints’ dynamic, versioned risk assessments automatically capture stakeholder input, allowing users to define risk control strategies, indicators, and thresholds. Our platform contains evaluation questionnaires and templates for users to easily customize and document the entire risk assessment process for filing in the Trial Master File (TMF).

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DOCUMENTATION

Signal & Action Tracker

Our Signal and Action Tracker model helps assess issues identified through Central Statistical Monitoring. Integrated action management documents steps within a unified issue management system, covering patent, site, and country concerns. Users can monitor signals and actions by status, annotate commentary throughout signal processing, deploy automatic auditing, and quickly share all activities with extensive exporting capabilities.

  • Manage all potential issues detected within our platform or externally with a Clinical Trial Management System (CTMS)
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On-Demand Demos

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