“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. However, Davidson is undaunted. As director of the Vault Study Startup application at Veeva, and with many years of experience overseeing global study start-up groups, […]
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 Site Research Solutions Inc., speaking from the perspective of managing more than 500 trials across various disciplines and types of sites. Communication and transparency are […]
In a surprise move, Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration (FDA), is leaving the agency in April, according to a report in The Washington Post. Gottlieb was appointed to the position in May 2017 by President Trump. Robert Califf, who preceded Gottlieb as commissioner, told The Post his successor did […]
It’s an increasingly common scenario: The patient filling out the traditional "gender" question on the demographic form was assigned female at birth, but may identify as male (transgender) or as neither male or female (non-binary). In this scenario, the simple binary male/female choices under gender on a demographic form are exclusive and create an uncomfortable situation for the […]
These are exciting times to be in the clinical trials industry, says Karri Venn, RD, CDE, CCRC, president of research for LMCǀManna Research in Toronto, Canada. With new technologies and concepts such as real-world data (RWD) and real-world evidence (RWE) coming to the forefront, the clinical trial 2019 landscape has evolved into “a new way […]
