With the adoption of ICH E6 (R2), risk-based quality management for clinical trials has become an expectation across the pharmaceutical industry. So, how is it working out in the trenches of daily operations? The Avoca Group’s research, documented in the 2017 Avoca Industry Report, indicates that, while there are concerns, there is also potential for […]
1996 – A year on the calendar which was punctuated with a number of firsts – DVDs were launched, the first mammal was cloned, eBay debuted as one of the hottest companies and closer to our space, the adoption of ICH E6 GCP became a reality. Oh and may I add that Google did not […]
In the last six months, I’ve often heard the term “firefighters” used to describe teams that work on drug development. Wikipedia defines a firefighter as, “a rescuer extensively trained in firefighting, primarily to extinguish hazardous fires that threaten property and civilian or natural populations, and to rescue people from dangerous situations.” Wow! Isn’t that a […]