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The COVID-19 pandemic has stalled multiple businesses and processes across the globe including clinical trials since there are critical activities that are carried out on site in-person such as informed consent. The impact is not just seen for new patients but also for existing patients who are required to provide re-consents in accordance with the COVID-19-led changes. To overcome these challenges, an expedited introduction and onboarding of an electronic consenting tool could be a solution. The virtual approach will enable sites to connect with patients without the need for in-person visits. This paper explores digital/virtual approaches to informed consent that could reinstate clinical trials and proceeds to study real-life implementation that Roche has executed to solve its remote consenting challenges for COVID-19 impacted clinical trials.
Hilde Vanaken

Senior Industry Advisor, TCS Life Sciences and Healthcare

Priyanka Sawant

Head, TCS ADD Patient and Site Engagement

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