About this Paper

In terms of managing trial risks effectively, the FDA and ICH guidance documents contain clear expectations for the deployment of Risk-Based Quality Management (RBQM). This approach calls for a documented risk management plan and recommends Central Statistical Monitoring, a technique which is driven by the use of statistical algorithms to interrogate all clinical and operational data, allowing trial stakeholders to focus on the issues that matter most.

What's Included in the Paper?

• An overview of where Central Statistical Monitoring fits in the risk-based operational process.

• The benefits that can be derived from adopting Central Statistical Monitoring.

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