Solving unmet needs in GLP1 cardiometabolic clinical trials: novel approaches to digital data capture & patient retention (Upcoming Xtalks webinar hosted by Clinical ink)
Summary
Recent US Food and Drug Administration (FDA) guidance has underscored these issues by mandating lifestyle standardization for obesity and diabetes clinical trials. In addition FDA is requiring hypoglycemia (either symptomatic or triggered by continuous glucose monitoring (CGM) devices) to be incorporated as a novel endpoint in some diabetes trials. Sponsors of upcoming clinical trials can select the most appropriate and FDA-compliant approach to capture these endpoints in a single GCP environment. To capture all these data in a single system Clinical ink has developed GlucoseReady™, an integrated GCP compliant digital platform. In this webinar, attendees will obtain recommendations for monitoring cardiometabolic disease in clinical trials and how compliance can be optimized with tracking, behavioral modification and lifestyle standardization tools.