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July 24, 2008
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.
Modern Data Monitoring
Lilly On EDC Changes
Lilly discusses how data management is changing in the era of electronic data capture.
Report from 'Partnerships'
Why BMS Outsources … Drug Safety
Moving work to India is not just about cost, says Bristol Myers. It’s about performance and quality too.
With the adoption of any new technology—from coal to lasers—lofty expectations are slowly eroded by the day-to-day reality of the technology in actual use. In the clinical trial landscape, the tool of the hour is electronic data capture (EDC). Is it helping? Is it making a difference? Jason Ridderikhoff, regional… more...
Some industries simply move jobs to India. Simple. Done. In pharma, the situation is more complex. John Balian, senior VP of global pharmacovigilance and epidemiology at Bristol-Myers Squibb (BMS) told the huge 2008 “Partnerships With CROs” conference in Las Vegas this week that his company has also had a more… more...
The 2008 Clinical Trials Congress had deep tracks of sessions around patient recruitment and trial budgeting. The familiar paradox is that as more sponsors seek more patients, patients become even more scarce. But now that conventional wisdom seems to be upside down. Instead of the familiar refrain of more patients,… more...
Talk about a rock and a hard place. Once drugs reach the market, or as a condition prior to approval, the industry’s handling of risk is caught between the needs of regulators, shareholders and public. At the 2008 Clinical Trials Congress, held in Orlando, there were signs that the burdens… more...
Jargon and catch phrases grate on our ears like fingernails on a blackboard. Plain old English is enough. Important-sounding buzzwords are designed to conceal the underlying ideas, not illuminate them. But in the case of “alliance management,” a phrase that sounds new to our weary ears, we may have to… more...
For the all the excitement and anticipation around adaptive designs for clinical trials, there’s always been one pesky fly in the ointment. Do regulators actually bless adaptive approaches when sponsors propose them? Has hype inflated expectations for such a promising technique? Adaptive trials—which include a statistical regimen to use the… more...
Our notebook still has a few gems from IIR’s Clinical Technology ("CTECH") conference, held last month in Philadelphia, which was where we heard Jane Clarke from Wyeth speak. One highlight is a presentation by Pfizer’s Mike Collins. A VP of development operations, he was the subject of this February story… more...
What is electronic data capture (EDC) in the end? Does it simply transfer the inefficiencies of paper case report forms to the internet? Or will EDC facilitate organization-wide efficiencies or even scientific discovery? Many companies in the life sciences are wrestling with whether to rebuild their systems and processes around… 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...
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...
