Keyword: Sponsor Investigator

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).

Training required for sponsor investigators conducting studies under an investigational new drug (IND) or investigational device exemption (IDE) to ensure compliance with investigational research regulations