Pfizer's Warning
Starting Over On Safety
Michael Ibara talks about the Aster project, which used ordinary electronic health records to expedite post-marketing adverse event reports.
SAS runs an annual one-day conference about healthcare and the life sciences. With merciful brevity written into its DNA, the meeting can pack its program densely with substance. There is no need for dreaded filler speakers enlisted mostly to accommodate some hotel manager's minimum revenue goal for the event. Steven Labkoff is an example of the sort of presenter that SAS attracted. He’s a cardiologist who is currently head of strategic programs in the R&D information department at AstraZeneca. Labkoff was on a SAS panel tasked with discussing such small matters as the long-term direction of the life sciences and the usage of "big data"—mountains of 1s and 0s in quantities needed by Procter & Gamble or the CIA. Even now, in its infancy, big data has multiple definitions, not all of which may be validly applied to a 50-patient Phase II rhinitis trial. Personalized Emphasis At AstraZeneca, Labkoff said, there…more...
"Big data" is both empty marketing language and a genuine business problem. IT firms are salivating to handle more data, with Google, EMC, Tibco and IBM positioning old tools for a…more...
The FDA is about to close its comment period for its new draft guidance on electronic "source," or master, versions of data in clinical trials. Should the agency implement and finalize…more...
"Source" or "esource" could be on the grapevine this year, as sponsors scramble to determine if their systems comply with a new draft guidance from the FDA. It was issued in…more...
Nextrials is a small but visionary San Francisco-based electronic data capture (EDC) firm. It had some ideas that took competitors years to duplicate. Nextrials offered built-in patient randomization, drug supply and adverse-event reporting years ago. We last wrote about the firm here. When we recently checked in with Nextrials' president, founder and CEO Jim Rogers, he said…more...
Some contract research organizations (CRO) had to be dragged into using technology. They presented at conferences, pooh-poohing software. They doubted, delayed, complained. They did not necessarily advocate fountain pens and carrier pigeons. But they could quote a price on ink and birdseed. And then there are people like Jules Mitchel, president of Target Health. He delights in…more...
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…more...
Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to the present drug safety morass of paper, faxes, and inefficiency. As head of pharmacovigilance information management at Pfizer, Ibara organized the Aster project, an exploration of…more...
Michael Ibara talks about the Aster project, which used ordinary electronic health records to expedite post-marketing adverse event reports.
The eClinical Forum discusses why sites don’t like the technology the industry spends billions on.
PhRMA is trying to help the industry understand and tap the potential of systems for electronic health records.
At the age of 10, Nextrials is aiming for an elevated competitive profile and connections to electronic health record (EHR) systems.
It’s auspicious. Suppliers of clinical trial systems and physician systems are integrating their software. An exclusive chat with Landen Bain.
Thoughts on a potentially transformative alternative to EDC, the electronic health record (EHR).
In a rare gaffe, Barack Obama’s team mis-routes a confidential strategy memo. A sobering look at what one advisor is thinking.
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