Risk-based monitoring, and its increasing awareness, is widely viewed as a clinical strategy contributing to better quality control, data accuracy and lower costs. The core of risk-based monitoring is Centralized Monitoring, which has evolved through three stages or “waves,” with value increasing at each wave. IQVIA has built and recently launched a technology platform that brings key centralized monitoring processes together from execution and technology viewpoints like never before. Read our insight brief - The Wave of Centralized Monitoring - for the latest insights on centralized monitoring.
Research indicates that awareness of risk-based monitoring (RBM) is very high, with a large majority of users believing that this approach contributes to better quality control and data accuracy. RBM is widely viewed as a strategy of upfront trial execution planning, identification of key risk indicators and use of efficient approaches to monitoring.
The core of risk-based monitoring is centralized monitoring, which has evolved through three stages or “waves,” with value increasing at each wave. The later waves leave clinical research associates (CRAs) with time to focus on sites and processes, applying strong critical thinking in a role of a “mini-auditor.” IQVIA has built a technology platform that brings key processes together from execution and technology viewpoints like never before. Using powerful proprietary algorithms, central monitors can drill down into site- and subject-related risks, and take appropriate action. The novel platform offers a rapid view of outstanding triggers and actions required, managing the workflow and providing an audit trail of actions to facilitate regulatory reviews. Based on marketleading expertise gained from IQVIA’s involvement with >300 studies utilizing an RBM approach, this insight brief describes current awareness and usage, key drivers and barriers, and elements of successful implementation.