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Info & Opinion
August 29, 2008
Does Windows have something to contribute to the clinical trial arena? Microsoft asserts its platform is more open and robust.
PharmaNet was downgraded from stable to negative by Standard and Poor’s, thanks to $60 million in lost contracts.
A Cincinnati-based CRO plans to stay medium-sized and private, despite a tidal wave of work that has started to come its way.
The industry’s image takes another hit in Britain. Unsolicited advice on avoiding similar encounters.
The modern clinical trial is built around a 2,000-year tool invented by the Chinese. Paper. Case report forms. Signatures. Binders of paper. Trucks filled with paper. FDA warehouses trembling under the heft of it. Some industries might be ashamed. Not ours. In the life sciences, every self-respecting company can talk… more...
In a hurry to dramatically increase enrollment for a trial? Have traditional methods lost their effectiveness? Then consider a custom DVD for principal investigators and other research staff. It will get them more invested in what you’re doing and simultaneously provide compelling instruction. Instead of the usual monotonous production featuring… more...
There’s no doubt about it. Site relationship management (SRM) has taken big pharma—and big biotech, for that matter—by storm in the last year. Where there are large, bureaucratic companies developing drugs, there are new SRM initiatives. And conferences on it now abound. But just what is SRM? Each sponsor and… more...
The people at Fast Track Systems are experts at the detailed analysis of clinical trial budgets by cost item, medical specialty or geographic area. The company has 25,000 protocols in its database, and adds perhaps another 4,000 annually. It offers software, services and data that help sponsors design and budget… more...
Yesterday, in a separate story, we talked with consultant George Laszlo about clinical data repository (CDR) functionality and terminology. This article is more forward-looking, and mentions some choices and long-term benefits for a CDR. Laszlo thinks the industry should ponder where clean clinical trial data should live. How easily will… more...
Is the data-handling part of the pharmaceutical industry being inexact in its use of some key terms? Is it preparing intelligently for the future? Consultant George Laszlo wonders. On the terminology front, he says sheer sloppiness is obscuring some of the most urgent priorities. His question: where exactly should the… more...
If you’re a small sponsor getting ready for a clinical trial, plan on shelling out at least $10,000 to $25,000 more per year than the actual cost of that study. This is not for investigators who suddenly want more money, or for extra recruiting efforts. It’s for clinical trial insurance.… more...
No wonder it’s hard for pharma and biotech companies to find and retain good clinical sites. Basic arithmetic and common courtesy are still sinking in. According to numbers from the Tufts Center for the Study of Drug Development (CSDD), on paper, clinical sites make 9 cents in profit for every… more...
Greg Seminack got a call from a friend who distributed drugs to clinical sites. He was deep in the finance world at the time. Seminack’s buddy mentioned that many of the sites he visited were in dire straits financially. Yes, they had contracted with some of the largest, most profitable… more...
Sitting there in Arlington, Virginia, at the ExL Pharma meeting on clinical trial design, we had an unexpected humanitarian pang. Was it cruel to put Robert Ruffolo, Wyeth’s president of research and development, on the program? Yes, Ruffolo has been making the rounds of the conference circuit for years. But… more...