Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Language-related issues come up quite frequently. Most interactions with regulators are held in English, but not all of them. In China, it is Mandarin, and in Japan it is, well, Japanese. In Europe, it is mostly English, but French and German occasionally creeps into the dialogue. In China, even if Continue reading REGULATORY INTERACTIONS – 2 The “KATA” of Proper Behavior
Oh, what a disaster: all the ACIP members were replaced for no good reason, the best and the brightest. Now children will die as incompetence rules supreme. The CDC’s guidance on Covid vaccination of healthy kids is being ignored, being made light of and challenged. We are looking at governmental Continue reading MUCH ADO ABOUT NOTHING: Covid-19 Vaccination for Healthy Children
Today’s topic is about the lackluster recruitment of US centers in recent CABP trials. We noticed that Eastern European (EE) centers, specifically from Ukraine, Bulgaria, and Serbia, contribute patients in large numbers, actually making these trials feasible. When sponsors and CROs needed to enroll CABP patients, they could not rely Continue reading CABP TRIAL ENROLLMENT – BUT NOT IN THE USA