elluminate RBQM

Risk-Based Quality Management (RBQM)

elluminate RBQM is an AI-driven platform designed to enhance risk management throughout the clinical trial lifecycle. It integrates all study data sources into a single platform, improving trial oversight and ensuring compliance. The platform supports trial efficiency, patient safety, and adapts to evolving challenges.

Comprehensive and Intelligent Risk Management

By integrating diverse data sources, elluminate RBQM provides a unified view of trial data, eliminating silos and the need for multiple applications. This holistic approach enhances visibility and prioritizes actions with intelligent risk scoring. AI analytics and real-time insights facilitate early issue detection, improving data integrity and patient safety. The role-based workflow engine and issue management integration ensure efficient risk management across teams, optimizing resources and reducing oversight costs and time.

End-to-End Quality Risk Management

Driven by regulatory guidance such as ICH E6 R2, elluminate RBQM is essential for patient safety and operational efficiency. It offers capabilities for integrating risk-based strategies and a phased implementation approach, benefiting trials of all sizes while ensuring compliance. The Risk Assessment and Categorization Tool (RACT) simplifies risk identification and assessment using a global library of questions and past assessments. Critical to Quality (CtQ) Factors and Quality Tolerance Limits (QTLs) are defined to monitor and act on risks. Key Risk Indicators (KRIs) are configured to track performance and uncover issues using advanced AI algorithms. Centralized Statistical Monitoring detects data errors and anomalies, while visualizations and dashboards provide site and country-level risk visibility.

Navigating Trial Complexity with RBQM

elluminate RBQM differentiates itself by being part of the elluminate Clinical Data Cloud, offering real-time integration and standardization for all trial data types. It provides a single source of truth, eliminating analytics silos and the need for multiple applications. The platform's native AI capabilities enhance risk detection, and its holistic view improves study status visibility for stakeholders. Built-in issue integration ensures seamless workflows between data management and monitoring teams.

Primary Users and Applications

Clinical Operations and Central Monitoring teams primarily use elluminate RBQM, but it also serves data managers and site monitors. The platform supports risk-based data review and performance monitoring, acting as an advanced data management workbench for cross-functional collaboration. It is suitable for outsourced models, ensuring efficient CRO oversight with a risk-based approach.

Additional Features

• The Risk Assessment and Categorization Tool (RACT) leverages the TransCelerate framework for quick implementation, though other frameworks can be used.
• Central Statistical Monitoring (CSM) capabilities allow configuration of KRIs and detection of systematic data errors and anomalies at the site level.