Keyword: FDA

Independent monitoring for IND/IDE investigator-initiated clinical trials

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

Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE).

Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics

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