Unveiling CluePoints’ New and Improved Risk-Based Monitoring Software

Today, we’re thrilled to unveil CluePoints’ latest release of its award-winning Risk-Based Monitoring Software. For this release, we wanted to hone in on several customer feature requests to deliver a solution that further advances the ability to meet the guidance proposed by regulators regarding Risk-Based Monitoring. In addition to an abundance of new features, we’ve expanded current functionality to further enhance the user experience.

Advanced Key Risk Indicator (KRI) Dashboard

A new version of the Key Risk Indicator (KRI) dashboard includes:

  • A centralized view of all of the KRIs activated for the study
  • Interactive graphs displaying relative scores and absolute values giving you both subjectivity and independent objectivity in the results
  • Larger icons to identify centres at risk

New Key Risk Indicator (KRI) Setup

The new release adds the ability to define Key Risk Indicators using CluePoints’ intelligent KRI setup wizard. It now takes seconds to set up a new KRI or amend an existing indicator with full audit history of who made the changes and why.

  • Define datasets, variables, tests, relative scores and absolute values
  • Add suggestive corrective actions based on the dataset/study
  • View adjustments to thresholds for the duration of study conduct with the new change history tracker

New Signal Tracker

What do you do when you identify a potential centre at risk? Based on customer feedback CluePoints has created a flexible approach to ensuring the workflow allows the right users to get the critical actions at the right time. Using CluePoints’ enhanced signal tracker you can:

  • Ignore, assign or watch potential issues that are surfaced
  • View all of the outstanding actions in a centralized view
  • Setup email alerts for actions
  • View and add comments against the signals and actions with a full audit history
  • Export the data

Seamless Integration with Medidata Rave Electronic Data Capture (EDC)

You asked, we delivered!

Hot on the heels of the integration with Oracle’s Inform, CluePoints’ new connector for Medidata Rave makes it easy to connect your study data to the CluePoints Risk-Based Monitoring platform.

  • One-time setup
  • Seamless integration
  • No custom coding required

About CluePoints

CluePoints is the premier provider of Risk-Based Monitoring and Data Quality Oversight Software. Our products utilize statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and the new ICH (E6) addendum, CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value of CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing optimization of central and on-site monitoring and a significant reduction in overall regulatory submission risk.

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