360° Monitoring: A New Approach To Dynamic Clinical Oversight Using Centralized Insights

Risk-Based Quality Monitoring (RBQM) is transforming clinical trial oversight by shifting from traditional, resource-intensive practices toward smarter, data-driven approaches. Medidata’s 360° Monitoring redefines RBQM by operationalizing a fully integrated, end-to-end quality management framework that begins at protocol design and extends through trial completion. This dynamic model replaces static, siloed processes with continuous, centralized insights and real-time risk surveillance.

By automating protocol digitalization, site selection, and risk assessments using historical data, AI, and predictive analytics, 360° Monitoring enables the proactive identification of critical-to-quality (CtQ) factors. Automated monitoring plans adapt in real time, aligning data quality efforts with emerging risks and minimizing unnecessary site visits. Centralized and statistical monitoring are seamlessly integrated, allowing for efficient detection of data inconsistencies and rater drift while informing dynamic, risk-based on-site monitoring activities. Ultimately, Medidata’s 360° Monitoring empowers sponsors and CROs to improve data integrity, reduce costs, and streamline operations by embedding RBQM principles throughout the clinical lifecycle. This unified ecosystem marks a pivotal evolution in monitoring, ensuring that quality is both proactive and scalable.