Top 10 Biopharma Achieves Significant Regulatory Efficiency by Enabling Advarra Connect TM Integrating IRB Platform and Biopharma eTMF Overview Executive Summary A top 10 biopharmaceutical company, responsible for managing hundreds of thousands of regulatory documents each year, was looking to expand its regulatory efficiency and automate key workflows between their IRB Platform and their electronic master file (eTMF). The Challenge Electronic trial master file (eTMF) systems are an important tool for research organizations to maintain compliance with regulatory agencies and present a historical look at the actions that have been taken over the course of a clinical trial. Study documentation in an eTMF typically come from multiple sources. Direct integrations of other systems

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