“Our IRB Specialist managing an IRB submission for a wearable medical device study.” Introduction: Why IRB Management Is Critical for Sponsors For sponsors launching clinical trials—especially in fast-moving sectors like wearable medical technology—navigating the Institutional Review Board (IRB) process is often underestimated. Yet IRB approval is a gatekeeper step: no data can be collected, no participant can be enrolled, and no study activity can legally proceed without it.

Introduction: Why IRB Management Is Critical for Sponsors For sponsors launching clinical trials—especially in fast-moving sectors like wearable medical technology—navigating the Institutional Review Board (IRB) process is often underestimated. Yet IRB approval is a gatekeeper step: no data can be collected, no participant can be enrolled, and no study activity can legally proceed without it. IRB management involves far more than filing forms. It encompasses preparing ethica