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Sponsors that choose to conduct remote trial monitoring during the COVID-19 crisis should focus on the most critical site documentation and source data and ensure the security of the data by creating a secure electronic viewing portal or using a sponsor-controlled electronic system or cloud-based repository, says an updated guidance the FDA released last week. Read More
Sixteen drugmakers have signed on for a major initiative by the National Institutes of Health to speed the development of COVID-19 therapies and vaccines. Read More
Reports of positive early results from a COVID-19 trial of Gilead’s antiviral drug remdesivir in Chicago are premature, according to the University of Chicago Medicine and Biological Sciences. Read More
As the desperate search for a COVID-19 treatment continues, two phase 3 trials in China of Gilead’s remdesivir as a treatment have been suspended due to the lack of eligible patients. Meanwhile, multiple trials of the drug in the U.S. and Europe are going forward. Read More