May 26, 2019registries

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Schizophrenic RFPs?

PharmaNet On Late Phase

August 04, 2010

With more than two decades in the industry under his belt, Jeffrey Trotter had his own contract research organization (CRO) for more than a decade. He sold it—twice. And now he's helping to shepherd the late-phase strategy at PharmaNet Development Group, where his title is executive VP, Phase IV development. He supervises a 50-person group dedicated to such projects. All of the large, global CROs routinely work in post-approval research, Trotter notes. They can all be competent. But only a few firms, his included, truly specialize in Phase IV studies and appreciate the nuances. One respect in which his firm is different, he says, is in an immediate recognition that such projects are not simply carbon copies of Phase III studies. "This requires a different approach," Trotter says. "Most of the industry has been trained and shaped by traditional randomized clinical trials. Unless you can deploy those resources in a different…more...

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New (Free) U.S. Guide To Phase IV

Outcome: Why Good Registries Matter

June 15, 2007

With Congress poised to legislate new mandates for post-approval studies, it seemed like a good time to talk to Richard Gliklich, the president of Outcome and a professor of surgery at…more...

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WHO Trial Portal, Amgen

News Briefs

May 08, 2007

The World Health Organization (WHO) says it is improving access to online data about clinical trials. It launched a web portal leading to several leading national databases about clinical trials. WHO…more...

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Post-Approval Summit

Politician, Serono Speak at Meeting

May 02, 2007

The Post-Approval Summit at Harvard, now in its third year, is the most cerebral conference on our calendar. It is also the meeting most larded with VIP speakers, including a preponderance…more...

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Drug Safety Link

McClellan On Mining EHRs

March 15, 2007

This week Mark McClellan, the former head of the FDA, said insurance data and electronic health records (EHRs) should be mined for insights into drug safety. His statement is unusual by itself. In the past, ex-FDA bosses tended to be circumspect. One can only surmise that the Bush administration and McClellan, its loyal soldier, have decided that…more...

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