Patient safety and data integrity are critical to the execution of a successful clinical trial. Increasing complexity of clinical trials and globalization have made monitoring and reviewing clinical trial data ever more challenging. Current practices used to evaluate protocol adherence and data entry are insufficient for identifying critical data quality issues often leading to missed adverse events, data anomalies and procedural deviations which could negatively affect timelines and lead to costly study delays. A mechanism that employs data analytics in the oversight of clinical trials can easily identify the complex errors which under normal practice can slip through the data management processes and edit checks.
Medidata Trial Assurance is a service that evaluates the integrity and quality of all clinical and lab data within a clinical trial. Our patent-pending statistical algorithms mine the clinical database automatically and identify anomalies, outliers, potential fraud or misconduct and procedural issues.
The offering includes a comprehensive analysis, report and presentation of the results by a team of clinical analysts led by two former FDA statistical reviewers. Medidata Trial Assurance provides actionable insight into clinical trial site performance and data quality enabling sponsors to work more effectively and attain faster, safer clinical trial data reviews