Clinical Trials (CTs) are needed to test the safety and efficacy of new therapeutic strategies. However they are also a painful and costly process: of the €46.7B spent in CTs, €14B (30%) was allocated to data handling. Such a high burden is the result of the inefficiency of the currently adopted data handling workflow that imposes manual transfer of de-identified health data from the medical center (MC) that treat patients to a clinical research database (EDC) for analysis. Manual data entry also inserts up to 9% errors that further require (manual!) correction. Such a lengthy, complex, and costly procedure delays CT duration and the adoption of more effective therapies, ultimately impacting patients’ health. Solutions aiming at increasing the efficiency of the data management process are strongly encouraged by Regulatory Agencies (EMA and FDA), but universal solutions are still lacking because of the use of site-specific EHR systems, trial specific-EDC, high conversion costs to a universal EHR system, and technical and regulatory constraints.
YonaLink developed YL System, an integrated platform that revolutionizes the entire data handling workflow by providing automated, cheap, 100% accurate, and secure data management. It eliminates the need of an EDC by extracting clinically relevant data directly from EHR and elaborating them into de-identified clinical data for the sponsor. The YL System brings CT data management to a new era where data are automatically collected, analyzed and exported, enabling Direct Data Capture.