The two year-old COVID-19 pandemic has forced the US Food and Drug Administration’s bioresearch monitoring inspectors to narrow the focus of their good clinical practice evaluations and document requests – whether conducted remotely or on-site – due to technological and logistical challenges.
Remote regulatory requests may be a “heavy lift” for a clinical trial site involving multiple days of videoconferences with site personnel, said Barbara Wright, supervisory investigator for the FDA’s foreign inspection cadre
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