Jan2025

Why EDC Needs RBQM for Smarter Clinical Trial Management

January 14, 2025|Comments Off on Why EDC Needs RBQM for Smarter Clinical Trial Management

With ICH E6(R3) reinforcing proactive quality management, relying on EDC systems with hundreds of edit checks is impractical. The MyRBQM Portal bridges the gap with predictive analytics, historical data views, and real-time risk drill-downs, enhancing oversight and reducing complexity. Learn how EDC and RBQM work together for more insightful, compliant trial management.

Jan2025

Maximizing Site Readiness for ICH E6(R3)

January 9, 2025|Comments Off on Maximizing Site Readiness for ICH E6(R3)

The ICH E6(R3) guideline redefines expectations for clinical trial sites, emphasizing proactive planning, data accuracy, and risk monitoring to enhance participant safety and trial efficiency. Download our presentation for practical insights and strategies to ensure compliance and strengthen collaboration.

Dec2024

Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

December 31, 2024|Comments Off on Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.