
FDA and EMA expectations shape how sponsors use CGM in diabetes trials, from blinding and study-provisioned devices to data integrity and ePRO integration.

Dr. Réka Balogh is a Scientific Advisor within the eCOA Clinical Science and Consulting team at Clario, part of Thermo Fisher Scientific. Her expertise spans electronic clinical outcome assessments (eCOAs), clinical outcome strategy, and patient-centered measurement. With a background in neuropsychology and neurodegenerative disorders, she has extensive experience in patient assessment methodologies and the measurement of cognitive, behavioral, and patient-reported outcomes. Dr. Balogh earned her PhD in Clinical Medicine, specializing in Clinical and Experimental Neuroscience, from the Doctoral School of Clinical Medicine at the University of Szeged.

FDA and EMA expectations shape how sponsors use CGM in diabetes trials, from blinding and study-provisioned devices to data integrity and ePRO integration.