Clinical Trial Data Reconciliation

10xDS developed a solution concept that automates the data reconciliation between Safety Reports and Clinical Reports in the context of Serious Adverse Events (SAEs) in Clinical Trials. Safety reports details adverse events or safety concerns observed during a clinical trial and Clinical reports provide detailed clinical assessments and analyses of the events. Variability in data sources and formats lead to discrepancies in the reported information, making it challenging to reconcile. Ensuring compliance with regulatory standards while reconciling complex datasets adds an additional layer of challenge. Limited interoperability between different platforms or software tools impeded the reconciliation process. Detecting subtle patterns or trends in large datasets was challenging without proper tools and resources. 10xDS designed and implemented a solution concept with Upload Phase for uploading reports, the Correction Phase to correct any data based on the notification from within the app and the Reconciliation Phase – to make a reconciled report available for preview within the app and for download. With reconciliation, accurate and up-to-date information to make informed decisions regarding participant management, protocol adjustments, and research continuation was possible. Increased quality and integrity of clinical trial data and increased compliance with regulatory standards and guidelines were made possible with the implementation.