Edge Trial Assurance
Erik Snider, Senior Director of Corporate Communications
Nearly 50% of new molecular entities (NMEs) submissions fail their first FDA approval, and 32% of these failures are attributed to data quality, data integrity, and data inconsistency issues, according to a 2014 JAMA article (https://bit.ly/2OMBekc). Medidata Edge Trial Assurance offers a new way to preempt submission of data errors by deploying anomaly detection across all lab and clinical data. Edge Trial Assurance identifies data issues with potential regulatory impact by putting machine learning algorithms into the hands of Medidata’s team of data analysts, led by former FDA statistical reviewers.
This novel solution integrates data from multiple sources into a profile report, and analyzes 1,000,000 data points and can find more than 4,000 patterns in less than one hour. The diagnostic findings drill down from study, to country, to site, to subject, quickly determining the normal, expected results for a selected study and highlighting the anomalies among patients and sites within the study.
The Edge Trial Assurance team performs a comprehensive, 360° analysis of study data, with an emphasis on data quality and study integrity, and provides a summary report and presentation of the results. This analysis of the study database identifies data quality issues that the customer is unaware of. Clinical trial sponsors gain immediate, actionable insight to improve clinical trial performance and data quality for the benefit of study results. Edge Trial Assurance prevents avoidable failure and facilitates high-quality, inspection-ready databases for submission to regulatory agencies.
The difference in approval time between NMEs receiving first-cycle approval and those requiring multiple cycles is 17.9 months. Edge Trial Assurance gives sponsors confidence in the quality of their data to avoid costly and timely resubmissions.