Wayne State University Streamlines Compliance with Validation Services for Advarra EDC

Achieving and maintaining 21 CFR Part 11 compliance when conducting IND and IDE trials can be a complicated and labor-intensive process. In order to take on these trials regulated by the FDA, sites must ensure their technology systems are validated to comply with applicable regulations.

Before bringing Advarra’s Electronic Data Capture (EDC) to their organization, WSU was using external vendors for 21 CFR Part 11 validation or conducting FDA trials using paper forms.

When Wayne State University (WSU) wanted to take on more IND and IDE trials, they chose Advarra EDC and Advarra’s Validation Service to help streamline the process.

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