Current Edition

eSource to SDTM: End-to-end Automation

The data generated during the development of new medicines come in a wide range of formats and may be generated from a variety of sources. Collecting, verifying and merging this data into a standardised format which is accurate and has the continuity to submit to regulatory authorities for approval requires deep understanding, expertise and flexibility. Annelies Van Zeveren, SGS,
explores how an eSource solution can allow end-to-end automation from electronic capturing of data at the clinical site to a high quality, submission-ready SDTM database.