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✪ VP ▫️ Transformational Leader ▫️ Business Growth Strategy and Scaling ▫️ Life Science Business Development Innovation
Exciting news today with the official launch of GlucoseReady! An example of true innovation. The GlucoseReady platform with CGM, BGM, weight scales, actigraphy, behavioral assessment, eCOA, Sensors and Wearables was matured in response to the May 2023 FDA guidelines which addresses the potential to include hypoglycemia as an endpoint as well as utilize Continuous Glucose Monitoring (CGM) to characterize glycemia and detect hypoglycemia. This requires not only real time data, but the ability to in-trial act on real time data. With GlucoseReady, CGM data is captured directly into the Clinical ink cloud. GCM based detection of hypoglycemic events trigger ePROs like hypoforms at the time of the event and provide a clear feedback loop to patients to contextualize CGM events when they occur and with structured ascertainment of patient’s symptomatology. Hope to see you on the Webinar on 7th May. https://lnkd.in/eRfdjcpH
Today we announce the launch of GlucoseReady™, an integrated GCP compliant digital platform designed for the new era of cardiometabolic clinical trials. The suite of tools including disease specific electronic clinical outcomes assessments (eCOA), behavioral assessment by the SPUR™ tool, lifestyle standardization, blood (BGM) and continuous glucose monitoring (CGM), digital weight scale and actigraphy. Unique endpoint features include ability of BGM and CGM to trigger hypoglycemia eCOA within the platform in line with the latest FDA guidance. Unique compliance features include prediction, tracking and prevention of non-compliance and drop out at site and patient level. Partnerships with leading digital device developers further reinforce alignment with FDA expectation for regulatory compliance. Together, GlucoseReady™ provides modules which used separately or together support multiple therapeutic areas including diabetes, chronic weight management and obesity and NASH/MASH, within a single GCP platform. It is specifically designed for user friendliness, patient and site support, as well as the requirements of an FDA inspection. https://lnkd.in/e2Df6A9p Learn more at our webinar on May 7: https://lnkd.in/eRfdjcpH #GlucoseReady #Innovation #ClinicalTrials #CardiometabolicDisease #DigitalHealth #Clinicalink
