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IND & IDE Support

Support for IND and IDE Applications

Clinical Research Compliance provides sponsor-investigators support with FDA-related regulatory requirements, including initial submissions, amendments, supplements, and annual reporting. For a detailed overview of the FDA regulatory support we provide, click here.

To request assistance with your Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, please fill out the IND/IDE Request Support Form.

If you have any questions or need additional help, don’t hesitate to contact us at ClinResComp@unc.edu.

Preclinical IND/IDE Research Support is not within the scope of services provided by OVCR:

  • Strategizing on the regulatory pathway for an IND or IDE
  • Offering guidance on the contents of the IND or IDE application, including additional studies or data that may be needed
  • Conducting detailed discussions with the FDA regarding study design and pre-clinical data required for advancing to clinical trial

For more information on preclinical research, please visit FDA’s preclinical research website.

Resources

ReGARDD – Regulatory Guidance for Academic Research of Drugs and Devices

ReGARDD is a collaborative initiative designed to support academic researchers in navigating the regulatory landscape for new drugs, biologics, and medical devices. ReGARDD provides invaluable resources and guidance to streamline the path from research to clinical application. Learn more about the how ReGARDD can assist your research efforts.

Guide to UNC-Chapel Hill Sponsor-Investigator Management of Multisite Studies

Successfully managing a multicenter study under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application demands meticulous planning and execution. The Guide to UNC-Chapel Hill Sponsor-Investigator Management of Multisite Studies was created to assist Principal Investigators in navigating each phase of their study with precision and adherence to regulatory standards. From initial planning to final reporting, our guide offers insights and practical tips to ensure your multicenter study operates smoothly and meets all compliance requirements. Whether you’re an experienced investigator or new to the field, this resource will support you in achieving successful outcomes in your research endeavors.