Comment from Sthenic Labs
AnonymousSupportBusiness
Summary: Sthenic Labs is submitting a formal response to the RFI, proposing a hardware-rooted architecture called the "Sthenic Protocol" to ensure data integrity in decentralized clinical trials. They argue that their technology provides a "physical root of trust" to prevent synthetic fraud and AI-generated data injection, enabling safer and more reliable AI-driven dose optimization.
Please find attached the detailed response from Sthenic Labs to the Request for Information regarding Infrastructure for Real-Time Clinical Trials (Docket FDA-2026-RFI-RTCT). The attached document outlines our proposed methodologies and hardware-rooted systems for maintaining data integrity in clinical environments. Thank you for the opportunity to provide input.