Case Study

Wayne State University Streamlines Compliance with Validation Services for Advarra EDC

Wayne State University Streamlines Compliance with Validation Services for Advarra EDC

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Customer Profile Founded in 1868, the Wayne State University School of Medicine is a world leader in research that is dedicated to discovery, creativity and community engagement. 1 WSU’s research portfolio is growing continuously, with a 37.8% increase in research funding from FY2015-FY2018. In addition, WSU is one of three research institutions in the University Research Corridor. Along with the University of Michigan and Michigan State University, the Corridor accounts for 95% of the research conducted in the state of Michigan. 2 Wayne State University Streamlines Compliance with Validation Services for Advarra EDC Executive Summary In order to take on IND and IDE trials regulated by the FDA, sites must ensure their technology systems are 21 CFR Part 11 compliant to adhere to

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