Who We Are


The University of North Carolina at Chapel Hill

The North Carolina Translational and Clinical Sciences (NC TraCS) Institute Regulatory Affairs Office provides regulatory support, guidance and education to the research community of UNC and its affiliates. Our aim is to lessen the regulatory barriers to translational research, by providing comprehensive support for researchers as they navigate the varying stages of investigational drug, medical device and biological product development and research. Some of our services include early consultations with the FDA, protocol review and evaluation, submissions of INDs/IDEs, DSMB support of phase 2 and 3 clinical trials, as well as assisting with long term maintenance and reporting requirements of clinical trials. The goal of our service is to advance science and discovery at UNC, while providing knowledge and empowerment for our academic investigators.

Amanda Wood
amanda_wood@med.unc.edu
http://tracs.unc.edu/index.php/services/regulatory

Who We Are