Abstract:

Decentralized clinical trials seek to offer more flexibility to patients by allowing them to complete some clinical trial assessments from their own home. Technical innovations have given patients the ability to complete PROs from their own phone, computer, or via phone interview with trained site staff personnel when needed, but how can we preserve data quality and meet compliance requirements with the high variability of data collection methods? How to face the increasing quantities of data collected and the rising complexity of regulatory standards?