Updated expectations in the International Council for Harmonization’s (ICH’s) guideline for Good Clinical Practice (GCP) E6(R2) are changing the way institutions and investigators calibrate and implement appropriate and adequate approaches […]
There’s nothing like getting backup from the U.S. Food and Drug Administration (FDA) during a debate with your boss. Just ask popular ACRP conference speaker David Burrow, PharmD, JD, director […]
Virtual clinical trials won’t eliminate the need for clinical trial professionals anytime soon, and the technology’s most dazzling predictions are likely years away from having a big impact on sites […]
“Study start-up timelines [had] been static for [many years] at about seven months. Now start-up timelines are even longer. The industry is trending slower,” says Ashley Davidson with Veeva Systems. […]
Quality is a state of mind. No, this isn’t a serene Zen master talking from atop a hill in Tibet. It’s Sergey Nikitin, BSc, MBA, president and director of Prime […]