Services

Specific services offered by the O3IS include, but are not limited to, the following:

  1. Provide information regarding current FDA regulations and guidance documents pertinent to the preparation and submission of investigator-sponsored IND and IDE applications and the conduct of clinical investigations under such FDA-accepted applications;
  2. Provide education to University researchers regarding the regulatory requirements and responsibilities associated with the conduct of clinical investigations under FDA-accepted IND and IDE applications;
  3. Assist University researchers in determining if there is a requirement for the submission of an IND or IDE application for their planned clinical investigations;
  4. Provide University researchers with guidance regarding the content of an IND or IDE application.
  5. Assist University researchers in identifying appropriate expertise and facilities as necessary for the preparation (i.e., “manufacturing”) of drugs and devices being evaluated under investigator-sponsored IND and IDE applications;
  6. Assist University researchers in identifying appropriate facilities for the conduct of cGLP-compliant, non-clinical (i.e., animal or in vitro laboratory) pharmacology/toxicology (i.e., safety) studies to be submitted in support of investigator-sponsored IND and IDE application;
  7. Assist University researchers with FDA communications related to planned, submitted, or accepted IND and IDE applications;
  8. Assist University researchers in complying with the regulatory requirements and responsibilities associated with the conduct of clinical investigations under FDA-accepted IND and IDE applications;
  9. Ensure institutional awareness of planned clinical investigations requiring the submission of University-based IND and IDE applications and/or of planned services (e.g., cGMP or cGLP facilities) to support the submission of such applications;
  10. Ensure institutional awareness of the submission of University-based IND and IDE applications and respective FDA communications;
  11. Coordinate Education and Compliance Office monitoring of the University-based preparation (i.e., “manufacturing”) of drugs and devices being evaluated under University-based IND and IDE applications; and
  12. Coordinate Education and Compliance Office monitoring of clinical investigations being conducted under University-based IND and IDE applications.

Note: Due to limited staffing, the O3IS is not able to draft IND or IDE applications, nor provide respective editorial services. To obtain editorial assistance, researchers should contact the Clinical and Translational Science Institute. www.ctsi.pitt.edu