We provide clinical regulatory assistance, guidance and education to investigators and study coordinators. We help ensure adherence with national regulatory and institutional requirements.

We support clinical and translational research through the following programs:

  • Scientific and tactical advice to navigate the drug and device development process
  • Preclinical consultation, IND gap analysis, guidance for CMC activities
  • Assistance in regulatory writing and consulting

Regulatory

We provide clinical regulatory assistance, guidance and education to investigators and study coordinators. We help ensure adherence with national regulatory and institutional requirements.

We support clinical and translational research through the following programs:

Preclinical Drug & Device Development

  • Scientific and tactical advice to navigate the drug and device development process
  • Preclinical consultation, IND gap analysis, guidance for CMC activities
  • Assistance in regulatory writing and consulting

IND & IDE Application Support

  • Investigational New Drug and Device Exemption application support
  • Clinicaltrials.gov registration support

Data and Safety Monitoring Board

  • TraCS Data and safety monitoring board (DSMB) oversight

Study Implementation

  • Protocol and IRB guidance and support
  • Clinical trial implementation services
  • Consent form and consent process guidance

Monitoring Plan Development

  • Review grants for adequacy of human subject protection
  • Development of monitoring plans
  • Clinical trial monitoring and audit preparation

Grant Submission Guidance

  • Guidance on completion of the human subjects and clinical trial information forms required for NIH grant submissions

Regulatory Education & Training

  • Regulatory training programs for faculty and the research workforce

ReGARDD.org

  • Affiliates at UNC, Duke, Wake Forest, and RTI share current best practices for preparing IND and IDE submissions to the FDA
NC TraCS Institute logo vertical

In partnership with:

Contact Us


Brinkhous-Bullitt, 2nd floor
160 N. Medical Drive
Chapel Hill, NC 27599

919.966.6022
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