Stanford

FDA Submissions – Drugs & Biologics (IND)

SDD

Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.

This stage includes tasks and activities that occur early in the design & development of a study, such as:

  • biostatistics consultations
  • informatics consultations
  • bioethics consultations
  • identifying co-investigators and collaborators
  • exploring funding opportunities

The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

  • Pre-IND Consultation Program
  • Guidance Documents for INDs
  • Laws, Regulations, Policies and Procedures
  • Emergency Use of an Investigational Drug or Biologic
  • Related Resources, including Applications

Training

Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.

Next Steps