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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.
As the FDA and other regulatory agencies embrace new clinical development approaches, how do sponsors and CROs promote new innovation while staying regulatory compliant?