Offering Category: Does your study involve an investigational drug or device?

Independent monitoring for IND/IDE investigator-initiated clinical trials

Worksheets to facilitate the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination

Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study

Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) pre-submission meeting requests to the FDA