Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…
The website “ClinicalTrials.gov” has become the first stop for many of us who need to check on trial activity of a particular drug. All larger human Phase 2 – 4 trials are listed there in quite some detail. While companies Continue reading And the Results are …Pending
Several articles in the April 7 issue of BMJ were devoted to the epic battle fought by BMJ and Cochrane to gain unfettered access to the Tamiflu® and Relenza® data. Not just some data, but all the data. Considering that Continue reading The War about Data Access