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

ReGARDD.org

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