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When it comes to risk assessment, it’s critical to look beyond what a CRA does.
Risk assessment must go beyond the concerns of operations or monitoring teams and span the entire organization – because the conversation is no longer just about monitoring.
Over the next few weeks, we will explore how to get started on a risk-based monitoring (RBM) approach in response to ICH E6 guidelines.
In our last post, we touched upon the current issues of site performance and why there’s a need for a quality-based approach to monitoring. In part two, we look at some of the takeaways from the webcast on how an RBM approach addresses these issues.
Check out a webcast with Christine Pierre, president of the Society of Clinical Research Sites (SCRS) and Medidata RBM specialists Dan O’Connell and Lori Convy as they explore a quality-driven approach to risk management to improve site performance.