Evolution & Revolution in Site Management

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Prior to the global coronavirus pandemic, inspecting clinical trial sites was especially resource intensive and onerous for sponsors as well as the clinical research associates (CRAs) responsible for executing this process. Preparing sites for a trial required CRAs to travel to several sites per week, conduct detailed site inspections and interviews, and complete reports. Burnout was a common problem which resulted in high turnover in this specialized, important role. In addition, time and cost investment for site monitoring represents a significant percentage of a study’s schedule and budget due to the travel required to access clinical research sites. This article will outline an industry-first approach to reducing the travel burden and the associated time and costs – a novel, wearable solution to enable site visits using live, first-person video. With this solution, a remote CRA can see what the study monitor sees in real-time, from facility tours to product label inspections.

Authored by: Emil Hoeck, Signant Health

This article is taken from International Clinical Trials August 2021, pages 60-62. Samedan Ltd

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