CharlesGroup both authored the research protocol and acted as principal investigator in these studies critical to device development and agency filing. We led design and revision of protocols, coordination with investigational review boards, obtained approval for proposed fielding, fielded the study and conducted analysis and reporting. All were compliant with FDA guidelines.
Critical to the success of this project was having a deep understanding of the development process the study should be serving, while addressing the complex criteria of FDA guidelines in study design, approval, fielding and reporting.