Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Aulus Cornelius Celsus wrote his famous book ‘De Medicina’ approximately 2000 years ago. Living in the times of Caesar Augustus, little is known about his persona. We are not even sure whether he was a practicing physician. Many of his books were lost but Volume VIII was rediscovered in the Continue reading New BIOMARKER CONSORTIUM PROs
Statements that have the words ‘FDA’ and ‘flexibility’ in a single sentence need to be approached with some skepticism. Especially if made by the Agency. ‘Flexibility’ always sounds better than ‘less rigidity’. Regulators are tasked with providing a certain sense of consistency or stability in the drug development jungle where Continue reading The New Default: 1 (One) Single Pivotal Trial
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