Rivka Siden, MS, PharmD

Clinical Research Project Manager: University of Michigan Medical School
Adjunct Clinical Assistant Professor
Michigan Institute for Clinical and Health Research (MICHR)
MICHR IND/IDE Investigator Assistance Program (MIAP)
Rotation Offered: Regulatory –IND/IDE and research support


In my position, I provide comprehensive regulatory support, guidance, and education services to investigators active in FDA-regulated clinical research.

  • Investigational New Drug (IND)/Investigational Device Exemption (IDE) application preparation and submission to the FDA
  • IND/IDE Consultation & Development; provides support for research involving investigational agents (drugs, devices, and biologics).
  • IND/IDE Lifecycle Maintenance offers support for all submissions that may be required by an active IND or IDE.
  • Clinical protocols development, review and editing

Pharmacy School Attended: University of Michigan (1992)

Areas of Interest

Protocol development and review (oncology), Patient education –investigational drugs, Regulatory (IND submission and support, expanded access) 

Published Articles or Reviews

  • SidenR, ModlinJ,Lee-Gabel L,RedicKA.Handout for research subjects receiving investigational oral chemotherapy. Am J Health-Syst Phar.2019; 76:2009-12.
  • Hertz DL, Siden R, Modlin J, Au L, Lee-Gabel L, Wong SF. Frequency and Description of Drug Interaction Screening within Southwest Oncology Group (SWOG) Clinical Trials. Am J Health-Syst Phar. 2018; 75:607-12.
  • Siden R, Redic K.Are you involved in a clinical trial: Here’s how to take your medications safely. ASHP SafeMediation website.