IND/IDE Consultation

The CTO offers consultation services to Sponsor-Investigators for both Pre- IND calls with the FDA and preparation of Investigational New Drug (IND) / Investigational Device Exemption (IDE) submission packets. The staff also guides Sponsor-Investigators through various stages of application and provides documentation review and tools.

IND/IDE Application

The services include:

Facilitating communications with the US FDA
Scheduling and preparing for a Pre-IND Call
Provide tools and checklists for IND/IDE submission
Prepare and/or review the IND/IDE submission packet
Maintenance of an IND/IDE through the life of the study
Safety reporting and annual reporting to FDA
Prepare and support during an FDA inspection
Facilitate mock FDA inspections
Training Sponsor-Investigator and study staff on regulatory responsibilities for an IND/IDE study

To request our services, please complete and submit the Request a Consultation form through the link below.

Request a Consultation

Other campus clinical trials offices

Medical College of Wisconsin Cancer Center CTO

MACC Fund Center for Cancer & Blood Disorders

Versiti Clinical Trials & Research Office

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.