Bridging the gap between device innovation and behavioral health clinical trial design
23 Sep 2025
Clinical Validation & Trial Design
- Lack of objective biomarkers in psychiatric and behavioral health trial endpoints
- Difficulty aligning multiple stakeholders- clinical staff, regulatory bodies, technical teams, IRB and the FDA — on study goals and protocol design
- Balancing speed in device development and scientific integrity — especially when validating a first-in-class diagnostic under high regulatory scrutiny
Industry Expert
