Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty penmanship it is, if you haven’t noticed. Just as a Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug
According to Janet Woodcock, 63 drugs have been given the “QIDP” designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development. So we are in fairly close agreement. That may seem like an impressive record but it is also Continue reading QIDP Drug Update – Part 2: Categories of Interest
The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes