Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
New medical and science journals pop up in our mailbox on a biweekly basis. Offers to join as Editor, solicitation for articles based on past publications, invitations for subject reviews come as unsolicited emails. Medical publication houses, old and new, are expanding, adding more and more subspecialties to their established Continue reading JOURNAL BUSINESS vs EDITORIAL OVERSIGHT
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
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