Core clinical engineering and protocols for Decentralized Clinical Trials.
Traditional pharmaceutical trials required patients to travel to hospital trial sites for infrequent snapshot physiological checks. Wearables enable continuous, real-world biometric data collection throughout the trial duration.
WearablesIoMT enforces FDA 21 CFR Part 11 compliance by cryptographically signing every data point at the sensor node. Audit trails confirm that the biometric telemetry originated from the authorized trial participant without tampering.