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.
基于风险的监控的核心是集中监测，该监视已通过三个阶段或“波浪”演变而成，每个波浪的值都在增加。后来的波浪使临床研究伙伴（CRA）有时间专注于站点和流程，在“迷你审计机构”的角色中运用强烈的批判性思维。IQVIA建立了一个技术平台，该平台将关键流程从前所未有的执行和技术观点汇总在一起。使用强大的专有算法，中央监视器可以钻入与现场和主题相关的风险，并采取适当的行动。该小说平台可快速了解所需的杰出触发器和动作，管理工作流程，并提供审核行动以促进监管审查。基于伊克维亚（Iqvia）参与使用RBM方法的300项研究获得的市场领域专业知识，此洞察摘要描述了当前的意识和用法，主要驱动力和障碍以及成功实施的要素。