YCCI provides a comprehensive, centralized resource for FDA submission of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), with staff members and consultants with Industry experience who provide “soup to nuts” IND/IDE support. This unit provides guidance on whether an IND is required; answers questions about the submission process; and assists researchers in complying with the regulatory requirements associated with IND and IDE applications. The ideal time to contact the IND/IDE service is before a research study is ready to move into human trials; consulting with these experts while still in the preclinical phase will ensure that investigators obtain the appropriate data needed for an IND application. In addition to assisting with collecting and compiling documents and submitting applications to the FDA, YCCI can help reduce the administrative burden on investigators by maintaining, managing, and monitoring INDs and IDEs, including those involving external sites; developing data and safety monitoring plans; assisting with the renewal of applications; and writing and submitting annual progress reports.
For information on IND/IDE Support please contact:
Amy C. Hummel, MS
Associate Director for IND/IDE Management
Yale Center for Clinical Investigation
2 Church Street South, Suite 112
New Haven, CT 06519