
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. Brian Rundle is a neuropsychologist and Scientific Advisor within the eCOA Science & Consulting team at Clario, part of Thermo Fisher Scientific, where he helps pharmaceutical and biotechnology sponsors optimize the collection of patient-centered and cognitive outcomes data in clinical trials. His work focuses on the design and implementation of research technology that balances regulatory compliance, scientific rigor, and intuitive user experiences to maximize data quality and participant engagement. He received his Ph.D. from Baylor University and completed a post-doc in neurology at the David Geffen School of Medicine at UCLA. With expertise spanning neuroscience, cognitive assessment, metabolic disorders, and connected devices, Brian works closely with sponsors to develop fit-for-purpose solutions for complex clinical research programs.

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