We’re delighted to announce that the recording for our COVID-19 webinar has been posted!
About the Webinar
The clinical research industry is in the midst of adopting Risk-Based Quality Management (RBQM) as a primary method for managing quality. RBQM encourages less reliance on traditional on-site monitoring including 100% source data verification/review (SDV/SDR), and greater reliance on centralized monitoring including the use of statistical methods to identify quality-related risks (e.g., unusual or unexpected data patterns).
CluePoints and our clients are accumulating an impressive body of evidence supporting the power of Centralized Statistical Monitoring in effectively detecting emerging issues not only effectively but proactively as well. Early detection is critical to success, to ensure that corrective actions can be taken in time to prevent significant damage to patient safety, trial outcomes, and related costs. CluePoints recently conducted “Data Quality Challenge” projects designed to demonstrate the ability of the CluePoints CSM solution to effectively and proactively identify sites with important known quality issues on previously completed clinical studies. The participating sponsor organizations provided completed clinical study databases to the CluePoints team with the following challenges:
- Can you identify the problem site(s) that the sponsor team discovered late in the execution phase of the study? The CluePoints team remained blinded to the scope and nature of the known issues, until after the initial analysis was executed on the completed study database and findings presented to the sponsor team
- How early in the conduct of the study would the CluePoints solution have identified the problem site(s)?
In this webinar, we presented and discussed the results of these data quality challenges, and also provided some key considerations and best practices for ensuring early detection of operational risks and issues and:
- The added importance of centralized monitoring as a quality monitoring tool in light of the challenges being imposed on site activities and site monitoring by the coronavirus (COVID-19) pandemic.
- Designing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for earliest possible risk detection.
Please feel free to share the recording with your colleagues and don’t hesitate to contact us if you need any support, advice and recommendations – [email protected]
