Regulatory assistance and guidance to investigators and study coordinators. Regulatory services include protocol development support, clinical trial monitoring (fee for hire service), guidance on regulatory considerations for NIH grants, and pre-clinical drug and device support via our partner RTI international.


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:

Study Implementation

  • Protocol development support and IRB guidance
  • Quality assurance / Study monitoring services on a fee for hire basis
  • Clinical monitoring plan development

Grant Submission Guidance

  • Guidance on completion of the human subjects and clinical trial information forms required for NIH grant submissions
  • Review grants for adequacy of human subject protection

Preclinical Drug & Device Development (via RTI)

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

  • Affiliates at UNC, Duke, Wake Forest, and RTI share current best practices for preparing IND and IDE submissions to the FDA
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In partnership with:

Contact Us

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

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Cite Us

CitE and SUBMit CTSA Grant number - UM1TR004406

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