A new guidance from the U.S. Food and Drug Administration (FDA) offers the agency’s latest thinking on the qualification process for drug development tools (DDTs), defined as the methods, materials, […]
One of the leading academic medical centers in New England has successfully leveraged adaptive business intelligence to foster change and significantly streamline clinical trial operations, a program leader told attendees […]
With apologies to new age gurus, successfully navigating an inspection by the U.S. Food and Drug Administration (FDA) is a state of mind, says Kara Harrison, MS, RAC, RQAP-GCP, a […]
PAID MESSAGE - Save to PDF, print, copy, file, repeat. Sound familiar? For those handling and managing the regulatory documentation at clinical research sites, it's a common workflow full of […]
Some of the biggest players in the drug development space worked to assure the U.S. Food and Drug Administration (FDA) they remain committed to improving diversity in clinical trial patient […]