Case Study: Wayne State University achieves 21 CFR Part 11 compliance and faster IND/IDE studies with Advarra EDC Validation Services

Wayne State University Streamlines Compliance with Validation Services for Advarra EDC

Wayne State University School of Medicine (Wayne State University) needed a scalable, 21 CFR Part 11–compliant system to support a growing portfolio of IND and IDE FDA‑regulated trials. To reduce the heavy paperwork and repeated per‑study validation burden that was slowing study starts, WSU selected Advarra’s Electronic Data Capture (EDC) system and engaged Advarra’s Validation Service.

Advarra validated WSU’s entire EDC instance and worked with the university to develop SOPs and walk staff through the end‑to‑end validation process. As a result, WSU now requires fewer technical resources to build, open, and maintain IND/IDE studies, has substantially reduced paperwork, and can open more investigator‑initiated and sponsor‑driven FDA studies without validating each study individually.

Wayne State University

Jackie Parker

Wayne State University