Clouds of Care Achieves Global At-home EEG Milestone in Pivotal Phase 3 Trial

Clouds of Care, a technology-enabled clinical development partner specializing in neurophysiology and digital health solutions, today announced a major operational milestone in its ongoing collaboration with Neurvati Neurosciences / GRIN Therapeutics: the successful activation of at-home overnight EEG assessments in the global Phase 3 Beeline trial of investigational radiprodil. With recordings now acquired in both the United States and Europe, and rollout underway in Asia and Australia, the program represents what is believed to be the first fully global at-home video EEG initiative utilizing specialized providers in a pivotal clinical trial.

The Beeline trial is evaluating radiprodil in individuals with GRIN-related neurodevelopmental disorders (GRIN-NDD), a rare pediatric condition for whom hospital-based overnight EEG has historically placed a significant burden on patients and caregivers. Designed across 16 countries, the trial incorporates at-home full-montage overnight video EEG as a core component, enabling the capture of naturalistic sleep and seizure data while reducing disruption to daily family life.

Clouds of Care is responsible for centralized EEG oversight and analysis across all participating countries for this particular study. At-home EEG acquisitions are performed by specialized providers, Neurotech and Deltaclinical.  Experience to date supports that the decentralized model delivers data quality that meets the standards required for a pivotal regulatory submission across diverse healthcare systems and geographies.

“What this program demonstrates is that decentralized neurophysiology can operate at scale, across continents and healthcare systems, without any compromise on data quality,” said Gregor Strobbe, CEO at Clouds of Care. “For families living with a rare pediatric condition, removing the need for hospital overnight stays is not a convenience; it is a meaningful change in how clinical research treats the people it is meant to serve. We are proud to be building that model together with the GRIN and Neurvati teams.”

The program spans North America, Europe, Asia, and Australia, making it the broadest decentralized at-home video EEG deployment in a rare disease pivotal trial to date. Clouds of Care views this milestone as an important proof point for the neurology and rare disease development communities: that patient-centered trial design and regulatory-grade data quality are not competing priorities.

“Integrating patient and caregiver perspectives into every stage of development is central to our mission,” said Anne-Marie Li-Kwai-Cheung, Chief Development Officer of GRIN Therapeutics. “This milestone reflects our continued focus on building a Phase 3 program that is both scientifically rigorous and meaningfully centered on patients and families.”

Beyond operational success, this milestone establishes an important precedent for the broader rare disease and neurology communities. It signals a shift toward more accessible and inclusive trial designs, where patient needs are embedded as a core design principle. Clouds of Care and GRIN Therapeutics will continue to expand at-home EEG implementation as the study progresses globally.