Clario’s New AI-Powered ECG Quality Score Tool Enhances Cardiac Safety Assessments

• Clario’s new ECG Quality Score tool leverages a unique artificial intelligence and machine learning approach to reinforce cardiac safety data quality

• It provides actionable insight to sponsors, enabling proactive remediation and peace of mind about data quality

• AI-powered tool complements Clario’s industry-leading early phase Early Precision QT (EPQT) solution that potentially enables waivers of traditional Thorough QT (TQT) studies

 Clario, a healthcare research technology company that delivers the leading endpoint technology solutions for clinical trials, is proud to announce the launch of its unique AI-powered ECG Quality Score tool, designed to enhance cardiac safety assessments in clinical trials.

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The AI-powered ECG Quality Score tool is a significant milestone in Clario’s commitment to providing better accuracy and efficiency for cardiac safety assessments through technological advancement. By leveraging an AI/ML approach trained on over 80,000 Phase 1 Healthy Volunteer ECGs, the Quality Score tool provides detailed information on whether the acquired continuous ECG data is of sufficient quality for further EPQT. It offers a proactive approach to study quality, allowing Clario to support sponsors in monitoring for quality in near real-time and remediate with solutions, such as site training or further recruitment, while the study is still active. This tool acts as an insurance policy for prospective studies with planned EPQT assessment. It is also particularly valuable for studies where ECG data is stored for potential assessment at some date in the future, giving sponsors confidence in the data that is collected and stored.

Ellen Street, Executive Vice President, Cardiac Safety at Clario, expressed the company’s enthusiasm, stating, “Clario’s ECG Quality Score tool embodies our unwavering commitment to advancing trials and technologies through the use of AI/ML. We aim to provide sponsors with better insights into cardiac safety earlier in the drug development process and equip them with the tools needed to make informed decisions and collect higher quality data.”

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The ECG Quality Score tool includes two detailed reports – the Early Precision QT Quality Summary Report and the Early Precision QT Quality Detailed Report – which together provide granular information about the quality of ECG data collected. It offers valuable insights and reassurance to sponsors by enhancing data quality assurance, reducing risks, and ultimately improving the likelihood of a definitive trial outcome, making it a valuable addition to Clario’s cardiac safety services. Initially, it will be rolled out to Clario Certified Sites as part of our focus on bringing new technology to our closest partners first.

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