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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 […]

CRA Turnover Hits 23% Internationally, 25% in US

Clinical Monitor Turnover Rates, Salaries Continue to Climb

Clinical research associates/monitors outside the United States don’t appear to be very happy in their jobs. According to a new “niche” survey from HR+Survey Solutions, international employee turnover in this job category leapt to nearly 23% in 2016. That’s up some 40% compared to 2015’s 16.4%. It’s not a much prettier picture in the U.S., […]