Category Archives: Product Updates

PatientProfile07

Patient Profiles unveiled as latest addition to CluePoints’ Risk-Based Monitoring and Data Quality Oversight solution

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We’re thrilled to announce that version 1.11.0 of CluePoints’ Central Monitoring platform, the enabling SaaS platform for Risk-Based Monitoring,  will be available to users in April!  Version 1.11.0 adds an abundance of new features (as requested by customers) and extensions to existing functionality.

There’s lots to cover, so let’s get started.

Patient Profiles

We have added Patient Profiles to the platform. Users can design and customize the patient profiles template using an intuitive and visual interface.

Patient profiles offer a new way to investigate atypical patients by looking at summary information from different datasets. Different data representations are available: tables, graphs, and Gantt chart.

Machine Learning(Beta Version)

We have trained a machine learning model to help users to benefit from decisions made in the past. A model has been distilled from 10 million scores in order to predict scores that should be associated with signal. In this first version, a machine learning model is used to assist the user in deciding which scores should be linked to a signal. In terms of user interface, a filter allows the user to only display the scores that need to be linked to a signal. The user can confirm which scores are signals and which scores are false positives.

Improved Key Risk Indicators

Based on the feedback we have received from our users, we have made some improvements in the Key Risk Indicators:

  • No minimum volume of data required: Previously KRIs were only displayed when enough observations to fit a statistical model were available. In the new version it is possible to assess sites using KRI absolute value thresholds even if it is not yet possible to fit a statistical model.
  • Improved user experience and navigation: We have added additional filters, and better organized the information on screen to facilitate the assessment and review of the KRIs.

That’s all for now!

If you would like a demonstration of the new features, please email contact@cluepoints.com.

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.

Like this post? Follow @CluePoints on Twitter for blog post alerts, industry news, and more!

CluePoints Risk-Based Monitoring Platform (Version 1.9.0) is Live!

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We’re thrilled to announce that CluePoints’ latest version (1.9.0) of the Central Monitoring platform is live!  Version 1.9.0 adds an abundance of new features (as requested by customers) and extensions to existing functionality.

There’s lots to cover, so let’s get started.

Trends Analysis

The addition of the trends analysis functionality provides the study team with a workbench to review the evolution of Key Risk Indicators (KRIs) and scores over time. This is especially helpful for study teams to look at the evolution of a specific indicator in order to assess for instance the effectiveness of an action taken. This feature will also facilitate the work of data analysts in interpreting scores for the Overall Data Quality Assessment.

Multivariate Tests

So far the statistical tests in the SMART statistical engine were mainly looking at one variable at the time. The correlation test allows the users to investigate the relationship between pairs of variables. The goal of this test is to detect an atypical correlation in a given center with respect to the correlation observed in all the other centers.

New Scatter Plot in Patient Level Data

A new scatter plot has been added to the patient level data screen in order to facilitate the interpretation of the results of the correlation test. The visualization allows to see the relationship between variables assessed for a given site versus all other sites. The user can interact with the graph and identify which point corresponds to which patients.

New Setup Screen

The all-new setup screen was created based on the feedback we received from customers. We merged some of the setup screens to provide the data analyst with a unified view of how the study is set up.

That’s all for now!

If you would like a demonstration of the new features, please email contact@cluepoints.com.

 

 

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.

Like this post? Follow @CluePoints on Twitter for blog post alerts, industry news, and more!

Unveiling CluePoints’ New and Improved Risk-Based Monitoring Software

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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.

Like this post? Follow @CluePoints on Twitter for blog post alerts, industry news, and more!