RBQM Is Our Future: Using Holistic Risk-Based Oversight, We Can Focus On A Trial's Most Critical Factors

Industry leaders recently convened at RBQMLive to discuss the evolving landscape of clinical trials, influenced by trends such as decentralized trials, growing data complexity, and the imperative of patient-centricity. At the forefront of managing these challenges is risk-based quality management (RBQM), which integrates risk assessment and centralized monitoring to uphold trial integrity. Insights from the event underscored the necessity for agile infrastructure and interoperable platforms capable of managing diverse data sources effectively.

This article further explores the pivotal role of RBQM in clinical trials, examining its current adoption trends and future implications. Embracing RBQM entails cultural shifts towards risk-based methodologies and collaborative frameworks across stakeholders. Regulatory support, as reflected in ICH's draft guidance on Quality by Design, emphasizes RBQM's potential to enhance trial efficiency and safety. The industry anticipates a transformative shift towards embedding RBQM as a foundational practice in modern clinical research.

For a deeper dive into these insights, read the full article below.