Charles Group, Inc.

Challenge
Design and field agency-required research, compliant with complex regulatory require- ments yet informative to the creative and analytical processes of product development teams.

Solution
Creation of a world-class team including medically qualified investigators, regulatory approval experts,, designers, and engineering experts to inform the study design and protocol writing. Coordinated with IRB (Investigational Review Board). Conducted HFE research, and generated reports compliant with regulatory and client SOP requirements.

Novartis

Guiding a Quantitative Study Through Regulatory Process

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.