Fact Sheet
Risk-Based Quality Management
Proactively Manage Risk Across the Clinical Trial Lifecycle Part of the elluminate Clinical Data Cloud, elluminate RBQM provides clinical teams with a single platform for all study data sources to support a more focused risk monitoring effort that enables better trial oversight and ensures compliance with regulatory guidance (ICH E6 R2 and ICH E8 R1). Because the effectiveness of RBQM relies heavily on the integration of diverse data sources, taking a platform approach enables greater cost-efficiency, improves safety, and provides the flexibility to adapt to evolving challenges.
Benefits: Data Unification & Integration
Scalability & Flexibility
elluminate’s ingestion and standardization capabilities for all data types creates a single source of truth for all trial data – eliminating data silos and the need to access multiple applications for high quality data.
elluminate RBQM offers a phased implementation approach that reduces adoption challenges, allowing trials of all sizes to benefit from RBQM while ensuring regulatory compliance.
Enhanced Patient Safety & Data Quality
Increased Efficiency & Cost Savings
A holistic view of risks across data sources enhances study visibility and helps prioritize actions. Access to analytics and real-time insights enable early issue detection, improving data integrity and patient safety.
A powerful role-based workflow engine centralizes issues and enables teams to address risks efficiently throughout the trial. By focusing on critical risks and automating processes, RBQM optimizes resources, reducing the cost and time spent on oversight.