implementing a Quality by Design approach to remote site monitoring by leveraging eSystems while remaining compliant
Site monitoring is one of the most important aspects of a clinical trial. It is required per ICH GCP to ensure that the rights and well-being of subjects are protected, the trial data are accurate, and the conduct of the trial is in compliance with the protocol, GCP, and applicable regulations. Many sponsor organizations still rely heavily on on-site visits where site monitors review all or most of the data entered on case report forms (CRFs) against the site’s source documentation. This approach is costly, both in dollars and resources. With the release of ICH GCP E6 (R2) in December 2016, some sponsors have moved towards a risk-based approach to monitoring, which often includes a remote monitoring component but the COVID-19 pandemic has accelerated this trend.
In this webinar, Janice del Rosario, TMF Consultant at LMK Clinical Research Consulting, and Mike Liccardo, VP of Corporate Development & CFO at ShareVault, explore how to implement a Quality by Design approach to remote site monitoring by leveraging your eSystems while remaining compliant.
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