Checking in on (RBQM) Risk Based Quality Management One Year After ICH E6(R3)
The industry is navigating a complex transition, balancing the adoption of innovative technology, maintaining study timelines, ensuring patient safety, and safeguarding data integrity.
The risk-based approach is foundational to creating a data-driven culture for clinical trial management. By leveraging Artificial Intelligence (AI) driven capabilities for signal detection and trend analysis, teams can proactively identify potential issues, centralize oversight, and prevent delays, all while maintaining data quality.
On January 6, 2025, the International Council for Harmonization (ICH) adopted the long-awaited E6 (R3) Good Clinical Practice (GCP) guidelines. This reinforces the need to continue efforts to modernize trial conduct by emphasizing a flexible, risk-based approach to study management and data quality oversight.
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