The U.S. Food and Drug Administration (FDA) has announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch “is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical […]
“Dire consequences could result if any eventual authorization or approval of a vaccine is influenced by political pressure and is not based on sound science,” three leading congressional Democrats wrote last week to nine pharmaceutical companies currently developing COVID-19 vaccines. The politicians are seeking further information about the companies’ research and development efforts, as […]
“There’s a lot more to becoming a principal investigator (PI) than meets the eye,” says Elizabeth Weeks-Rowe, LVN, CCRA. Too often, prospective PIs think it’s a matter of taking a few courses before embarking on the new career journey. Wrong, says Weeks-Rowe. “There’s so much more they need to understand,” she says. For example, new […]
PAID MESSAGE The COVID-19 pandemic is a challenge that is forcing us to reexamine how we do pretty much everything. There is no roadmap—just a barrage of mutable information. For those of us conducting clinical trials, the stakes are huge. Study disruptions put the time and resources already invested at risk and potentially delay […]
Clinical trial experts from across the entire industry ecosystem took on the vexing problem of underrepresentation of minority populations in clinical trials at a September 15 summit sponsored by the Association of Clinical Research Professionals (ACRP) and The Avoca Group. Evonne Lackey, CCRP, director of clinical research at the Swedish Cancer Institute, said the industry […]
