Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions

被引:0
|
作者
Nimita Limaye
Veena Jaguste
机构
[1] Biotechnology,Oshiwara Industrial Centre
[2] Nymro Clinical Consulting Services,undefined
[3] Healthcare and Clinical Research Consultant,undefined
来源
Therapeutic Innovation & Regulatory Science | 2019年 / 53卷
关键词
clinical trials; protocol design; QbD; central monitor; KRIs;
D O I
暂无
中图分类号
学科分类号
摘要
Risk-based monitoring (RBM) has disrupted the clinical trial industry, challenging conventional monitoring norms, business processes, and organizational structures. Endorsed by regulators and leading industry forums, and further driven by escalating drug development costs and enabling technology shifts making data available real time, the industry is moving from a mode of recalcitrance to acceptance. The effective implementation of RBM requires delicately interweaving changes in technology, processes, people, and perspectives. This article deliberates upon the multiple challenges that exist and proposes potential solutions.
引用
收藏
页码:183 / 189
页数:6
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