Editor's Note: Through association with certain spiritual mentalists and accredited acupuncturists, the editor of ClinPage has received what he has been assured is a bonafide transcript from nine years in the future. From the year 2019, to be precise. The transcript below purports to be the byproduct of a U.S. Freedom of Information Act (FOIA) request. It…more...

Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to the present drug safety morass of paper, faxes, and inefficiency. As head of pharmacovigilance information management at Pfizer, Ibara organized the Aster project, an exploration of…more...

If pharmacovigilance were a movie, it would be Groundhog Day, except as a tragedy. Here's the plot. Reports of adverse events (AE) pop up and take years to be evaluated. The associated recriminations bounce between various interested parties. Good drugs exit the market. Bad ones linger. The industry's reputation gets bludgeoned either way. Luck is at work,…more...

These days, can a clinical development program have too much safety? While risk evaluation and mitigation strategies (REMS) are hardly new, as this list of them on the FDA website attests, they remain only partially understood. In its own conversations with the sponsor community, Quintiles realized that many in the industry are unaware of the full spectrum…more...