Glossary Term
Centralized Monitoring
Definition
Centralized Monitoring is a risk-based approach used in clinical trials to assess data and site performance remotely from a central location. It involves using advanced data analytics and technology platforms to detect anomalies, trends, and risks in real-time, ensuring trial integrity and compliance without the need for frequent on-site visits.
Relevance to the MedTech Industry
Centralized Monitoring enhances the efficiency and effectiveness of clinical trials by enabling early detection of data inconsistencies, protocol deviations, and site performance issues. It reduces operational costs while maintaining data quality and regulatory compliance, which is especially critical for the development of medical devices.
Additional Information & Related Terms
Risk-Based Monitoring (RBM) A broader strategy that includes Centralized Monitoring as a key component.
Electronic Data Capture (EDC) Systems used to collect and manage trial data in centralized monitoring.
Clinical Trial Design Centralized Monitoring supports adaptive and risk-based designs for trials.
Post-Market Surveillance Centralized Monitoring can be applied to gather and analyze real-world data post-approval.