The Case For Outreach
October 12, 2007
A few years ago, thinking the way all journalists think, we had an epiphany. The reportorial brain is the one we’re happily stuck with. But it often adopts a harshly negative, critical outlook that transcends age, geography and political affiliation. We resolved to outgrow that outlook.
Then, as luck would have it, we met a few journalists…more...
A Chance To Give Back
September 10, 2007
There is an article in the British Medical Journal related to international aspects of drug safety in the developing world. “Pharmacovigilance in the Developing World,” written by researchers in England and Ghana (Munir Pirmohamed, Kwame Atuah, Alex Dodoo and Peter Winstanley), points out the inadequacies of the networks for drug safety in much of the impoverished world.…more...
Adaptive Logistics
August 06, 2007
The math of adaptive trials is hairy. But the appeal is simple. Adaptive trials can reveal the optimal dose in a single trial—not six. They can identify dud drugs early. The approach can require significantly smaller sample sizes and save big companies billions of dollars.
There’s just one mathematical fly in the clinical ointment. Adaptive trials will,…more...
Phase Forward, OmniComm, Target Health
July 25, 2007
Clinical technology suite Phase Forward reported another apparently effortless set of strong financial results. Revenues for the second quarter of 2007 were $31.5 million, a 28 percent increase from $24.7 million in the second quarter of 2006. Within total revenues, electronic data capture license, application hosting and other related revenues were $22.8 million, an increase of 39…more...
The ClinPage Checklist
22 Questions For Adaptive Trials
As life science organizations consider adaptive clinical trial designs, the process, technology and operational aspects are complex. What to consider.
Small, Flexible, Nimble
Prometrika Growth Strategy
Prometrika, a CRO, is adding a clinical-operations arm with the help of a veteran from Nucryst Pharmaceuticals.
Linking Tools for Supply, Randomization
An Adaptive Partnership
Cytel and Tourtellotte consulting have integrated two important applications.
New Tools, More Trials?
Radical Drug Safety Shift
Proposed legislation would profoundly alter the U.S. drug safety landscape.
'Sentinel,' Other Tools Planned
FDA Outlines Major Safety Overhaul
The announcement by the FDA is an ambitious, major effort to reassure the public without explicitly committing the agency to yet another layer of regulation or any specific, lasting changes to how drug safety is reviewed after drugs are brought to market.
Rethinking Everything
Drug Safety Landscape Shifts
The comments from Relsys were made before the recent FDA announcement about drug safety.
Funds for IT, post-marketing, safety
FDA: Raise PDUFA Fees 29 Percent
The agency says $29 million of $87 million in proposed new spending would go toward 80 additional employees to monitor drug safety in the post-marketing arena.
