Leading Medical Device Company Adopts Remote Source Review As New Standard

Prior to the pandemic, the medical device company had been moving toward a risk-based approach to monitoring clinical data, including using site-based tools where practical. However, the company did not have a dedicated tool to support large-scale remote monitoring across all of its studies.

When in-person interactions with sites became limited with the shut downs and travel bans caused by the COVID-19 pandemic, remote monitoring turned from an aspiration to an imperative. The medical device company’s clinical leadership from across six divisions met to identify their highest risk studies and to adopt a standardized remote monitoring tool. They identified 45 critical studies and set an aggressive goal of having a solution in place within three months. That meant selecting this solution, then building, testing, verifying, and rolling it out in record time.