Medical Imaging and Electronic Data Capture in Clinical Trials: The Future Paradigm

All clinical trial data are ultimately digital. The pathway to this digital database is not always as connected as one might expect in this technological age. The backbone of clinical trials is now Electronic Data Capture (EDC), and this is not yet synchronous with the other major aspects of data collection, such as medical imaging. With the need for more streamlined processes, this paper explores the combination of medical imaging with EDC and provides the future paradigm for the triallist in the digital age. This will not only ensure an earlier final database lock, which is a key milestone, but during the trial data quality control (QC), and specifically image data QC, and evaluation can be performed in a more contemporaneous fashion with immediate feedback to those managing the study and the local investigator site. The ultimate goal is to unify all the essential data in a standardised format to expedite submissions and to increase the quality of those submissions.

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