To facilitate advancement of CU Anschutz researchers’ innovations through expert support and collaboration to manage administrative, regulatory and safety elements of the product development lifecycle.
The IND/IDE Program at CU Anschutz was established in 2023 under the directive of the Vice Chancellor for Research, Dr. Thomas Flaig.
The team consists of the IND/IDE Office (Vice Chancellor for Research) and the Cancer Center (School of Medicine). Research projects will be triaged to either entity based on project type and therapeutic area.
The program provides expertise and assistance to researchers involved in the development and clinical assessments of novel health solutions for investigator-initiated studies. We do this by partnering with research teams to centrally manage the responsibilities that are unique to the role of being a regulatory sponsor for FDA-regulated research.
So you can concentrate on your scientific work!
The collaboration between a central group of regulatory specialists and dispersed research teams with expertise in distinct disease areas allows for standardized and streamlined communication with FDA, thereby accelerating the process to obtain permission to proceed with research under FDA oversight.
The transfer of many of the administrative and regulatory sponsor-specific tasks from the research team to IND/IDE Program staff allows research teams to focus on the scientific aspects of their research and the clinical care of study participants.
IND/IDE Office team will: