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The CRSO Offers Complimentary IND/IDE Services!

The mission of the CRSO IND/IDE Support Team is to provide exceptional support to Principal Investigators also acting as the Sponsor of FDA regulated investigational drug and device clinical trials at the University of Utah.

FDA regulations for sponsors and investigators are complex, and failure to comply with all research regulations that govern clinical trials brings a high degree of risk to the University and its researchers. Our IND/IDE Specialist has extensive experience working with the FDA.  It is strongly recommended that sponsor investigators utilize these services to eliminate risk and stress for all research staff at the University.  We are here to help. 

If you choose not to utilize our IND/IDE services, it is required that we review your documents prior to FDA submission.

 

Our IND/IDE Services Include:

​​​​​​​Consultation regarding IND and IDE regulatory requirements for research studies

​​​​​​​Pre-INDs and pre-submission meetings

​​​​​​​File Initial INDs and IDE submissions

​​​​​​Amendments

​​​​​​Supplements

​​​​​​​Safety reporting

Annual reports

IND/IDE Closeouts

Contact Us for IND/IDE Support

CRSO.FDAsupport@hsc.utah.edu

PHONE: (307) 709-0119