Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|April 2, 2020
Remote Monitoring Now Available in Veeva SiteVault Free
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Veeva Systems pushed forward on its remote monitoring capabilities in its Veeva SiteVault Free in response to the COVID-19 crisis. Those capabilities for source document review and verification, usually performed on-site, are contained in its free eRegulatory application. This allows study monitors to access, review, and collaborate on content online. Sites can centralize monitoring and communication with sponsors and CROs that is compliant with 21 CFR Part 11 and HIPAA requirements.
According to a survey conducted by Clinical Research IO, 63% of sites reported they have prohibited on-site monitoring by pharma sponsors and their agents. “Remote monitoring supports the immediate need for sites and study monitors to continue working together while onsite visits have largely stopped,” said Bree Burks, vice president of site strategy at Veeva and a former clinical research director. “Veeva SiteVault Free gives sites access to remote monitoring capabilities, at no cost, so they can keep running studies and treating patients.”
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