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October 12, 2008
Stopping Traffic
Coast IRB’s DIA Psychic
Close encounters on the 2008 DIA exhibit floor. Plus Nintendo Wiis, flat-screen TVs, stuffed animals and Russian dolls.
DIA Pre-think
Rivers of Clinical Bits
What’s different this year. Random thoughts on our personal nemesis, paper, and the alternative.
Business As Usual
Wyeth on FDAAA
Joseph Camardo spoke at the Post-Approval Summit at Harvard, and was wicked smart. Even so, what he didn’t say perturbed us.
Top '08 Talk
Realizing (Or Missing) EDC’s Potential
Consultant Ron Waife of Waife & Associates discusses what eclinical means and why it matters.
Fixing A Twisted System
For-Profit Conferences: Evil or Essential?
The conference industry should borrow an idea from the medical journals, our guest author says.
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...
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...
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… more...
In the world of running, the ultramarathon is anything longer than a 26-mile course. Some people run from one rim of the Grand Canyon, down to the bottom, and up to the other rim. And back. In a day. They call that an “R2R2R.” Adaptive designs are the ultramarathons of… more...
Editor’s note: This story has been revised since it was posted on June 29, 2007. Contrary to our initial article, Pfizer has never asked any site to choose between working for Pfizer and another sponsor. As it explained at DIA, however, Pfizer is guiding more sites and investigators to either… more...
Does Microsoft matter in clinical trials? Is it staring numbly at the start of an era of enterprise-worthy, web-based tools from Google? Or does Microsoft have unique hardware, application and networking tools that make it a more or less indispensable part of the technological infrastructure of the modern clinical trial?… more...
Everest Group is a Dallas consulting firm that has been surveying the pharmaceutical industry to plumb the depths of its relations with suppliers. Like a marriage counselor fearlessly going into topics that neither spouse wants to look at too closely, Everest is seeing warning signs. Those signs are all the… more...
Globalization is often pretty simple. A large western company travels to a distant land, hires the local workforce, and resells its labor with a suitable markup. There’s just one problem with this scenario: Who needs the large western company? Isn’t it just adding a crusty layer of overhead and management… more...
Rob Musterer is director, clinical systems support at Bayer Healthcare. He is also head of a center of excellence dedicated to information systems for clinical R&D systems. Musterer has worked in the industry since 1981, and has watched several cycles of technology come and go. Like many people in the… more...
John Orloff is VP of development at Novartis. Like other keynote speakers at the recent Clinical Trials Congress, he’s not inclined to coat the industry’s predicament in sugar. “R&D expenditures are soaring at a time when new medical entity approvals are stagnating,” he said. “This is a paradigm that is… more...
