The FDA is conducting clinical trial oversight through informal remote review of site, sponsor and CRO records while the COVID-19 pandemic is limiting the agency’s ability to conduct traditional on-site inspections. But the agency stresses that these reviews are not taking the place of formal inspections and possible enforcement actions. Read More
COVID-19 has given the clinical trials industry the push it needed to go paperless, with 84 percent of sites, CROs and sponsors already doing so or poised to make the switch to electronic data management (EDM) systems. Read More
WCG Clinical last week announced it has unified its five separate IRBs under a single WCG IRB banner and launched a new IRB submission platform. Read More
The National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study of the potential of approved therapies and late-stage investigational drugs for hospitalized COVID-19 patients. Read More
In newly released guidelines, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recommends using confirmed SARS-CoV-2 infection, arterial oxygen saturation, requirement of oxygen therapy and death as key study endpoints for clinical trials evaluating COVID-19 vaccines. Read More
Approximately 51 percent of patients in clinical trials are concerned about coming into contact with other participants who may have COVID-19, prompting nearly 83 percent of U.S. sites to adjust patient scheduling to limit the number of participants in the office at the same time, according to a survey of 268 U.S. clinical trial sites. Read More
