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COVID-19 Webinar

Beyond COVID-19: The New Normal in Risk-Based Monitoring (RBM) and Quality Management (RBQM)

Join our next webinar to learn first-hand how the CluePoints and Parexel partnership is driving best-in-class Risk-Based Quality Management Strategies to support clinical development. This session will focus on how early risk detection can be leveraged to detect issues across your trial and ensure operational excellence. As the COVID-19 pandemic continues, actions need to be prioritized to combat the disruption to both new and in-flight trials. We believe the challenge of identifying and actioning these critical issues in a timely manner will be the catalyst in driving the adoption of central/remote monitoring for all trials from this point on. We will share best practices for rapid use today and future adoption as we enter a new normal.

KEY DISCUSSION POINTS FOR THIS WEBINAR:

  • Enhanced data quality oversight and regulatory compliance
  • Proactive risk management to protect patient safety and support site conduct
  • Driving improved quality, accuracy, and integrity of clinical trial data
  • Increasing productivity, efficiency and cost effectiveness for sponsors

WE WILL BE RUNNING TWO SESSIONS TO ACCOMMODATE DIFFERENT TIME ZOMES:

Tuesday, May 12, 2020 at 10:30 AM EDT Registration

Wednesday, May 20 at 11:00 AM IST Registration

We hope that you can join us and please feel free to send us questions that you’d like to see covered during the event via contact@cluepoints.com.

Webinar Recording: The Critical Importance of Early Risk Detection with a Special Feature Addressing COVID-19

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.
Watch the Webinar Recording

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 – contact@cluepoints.com