Successful risk-based monitoring extends well beyond just risk detection.
The clinical R&D industry needs to deliver on the promise of quality improvement and cost reduction both operationally and from a regulatory perspective. We must be able to show evidence that due planning and oversight has taken place during a study by building an audit trail of the way risk has been detected, managed and mitigated throughout the duration of the study. Study teams need to be able to collaborate around a common operating platform to ensure an understanding of what monitoring activity needs to take place, when and why. Study managers need to see that risk mitigation activities have occurred and, ultimately, determine if the approach has been effective in improving quality, and if not, adjust the monitoring approach accordingly. This session discusses an approach, supported by technology, to:
- Determine which risk indicators make the most sense for your study
- Create and execute an operational process for quality risk management
- Define and track risk mitigation activities that have been completed
- Determine overall success from a quality/risk perspective and adjust strategy if necessary
- Report outcomes for the final study report
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