“We aren’t conducting clinical research with the rigor that we should be today,” says thought leader Jeff Kingsley, DO, MBA, CPI, FACRP, CEO of the site network IACT Health. “We’re slow to change and slow to build needed infrastructure, especially at the site level.” This aversion to change or being stuck in a mode where […]
A former Supreme Court Justice, struggling to define the term pornography in a landmark case, famously hedged his bets by saying he knew it when he saw it. Many research professionals feel a similar challenge when defining the term quality—especially when examining it in terms of the various stages of a clinical trial. “I'm a […]
Health Quest Systems Inc. (HQS), a four-hospital health system operating in New York’s Hudson Valley and northwest Connecticut, is betting big on artificial intelligence (AI) as a way to boost stubbornly low enrollment rates in some clinical trials. HQS announced today (March 21) it will deploy IBM Watson for Clinical Trial Matching, a cognitive computing […]
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 for qualifying external labs and other testing facilities, and for ensuring oversight of many of the trial-related tasks delegated to those outside organizations. Industry has […]
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 of the FDA’s Office of Scientific Investigations within the Office of Compliance for the Center for Drug Evaluation and Research. “Some of the most rewarding […]
