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FDA Seeks Comment on Submissions Template, Emphasizes Importance of eData Integrity

The U.S. Food and Drug Administration (FDA) is seeking comment from drug developers and other stakeholders regarding whether to recommend, with or without suggested modifications, a proposed Analysis Data Reviewer’s Guide (ADRG) template for regulatory submissions. It’s part of FDA’s ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, nonprofit consortium addressing computational […]

Julia Lombardo, Clinical Operations Manager, C.R. Bard

C.R. Bard Upgrades Trial Master File Capabilities to Lift Trial Performance

Working to bring together disparate trials operating in silos around the globe, medical device giant C.R. Bard went from proof of concept to launching an active electronic trial master file (eTMF) operation in just over two years. It was an idea whose time had come, according to Julia Lombardo, clinical operations manager. With more than […]