In the rapidly evolving landscape of clinical trials, the shift towards remote monitoring has become a pivotal strategy for enhancing efficiency and maintaining high standards of data integrity and patient safety. This transformation, driven by technological advancements and the necessity for adaptive methodologies, was the focal point of a recent IQVIA webinar. The session provided a comprehensive overview of the evolution of clinical monitoring, the implementation of risk-based quality management (RBQM), and the future trajectory of remote monitoring within the Functional Service Provider (FSP) model.

Risk-Based Quality Management (RBQM)

At the core of this evolution is the implementation of risk-based quality management (RBQM). RBQM extends beyond monitoring to encompass quality management across all aspects of a clinical trial. This comprehensive approach involves designing protocols with inherent quality, implementing risk prevention strategies, and continuously monitoring quality metrics throughout the trial.

Key components of RBQM include:

• Protocol Design: Ensuring protocols are designed to minimize risk and facilitate high-quality data collection.
• Risk Assessment: Conducting thorough risk assessments to identify potential issues and implement mitigation strategies.
• Continuous Monitoring: Utilizing key risk indicators and data surveillance to monitor trial quality and integrity in real-time.