Endpoints built for devices
Statistical analysis plans built around performance, safety, and functional outcomes, including non-inferiority designs common to device studies.
Why device sponsors choose us
Built for a different clock
Three ways NoyMed's model adapts to device-specific endpoints and iterative design.
Coordination through design changes
Clinical Operations manages protocol amendments and site retraining as device iterations occur mid-study, keeping enrollment and data collection on track.
Human factors & usability built in
Site management covers human factors and usability testing alongside standard monitoring, so device-specific evidence isn't a separate engagement.
Common questions
Before you scope a device study
Navigating an IDE or pivotal study?
Tell us your device class and where the design stands — we'll scope biostatistics and site coordination around it.