DAVID M. HARRIS, PhDServices
Regulatory Strategies & FDA Submissions
Clinical Trials: Design & Supervision
Funding Strategies & Applications
Clinical Trials: Design and Supervision
BMC, Inc. can assist with any or all aspects of conducting medical device clinical trials
- Poll FDA for safety and efficacy issues
- Design of clinical trials
- Performance site and physician-investigator selection and training
- Institutional Review Board documentation
- IDE applications to FDA
- Written protocol, data collection forms and other documentation
- Monitor clinical trials
- Data collection, statistical analyses and interpretation
- PMA and 510(k) applications to FDA.
Contact us for a free initial consultation.