Dictionary Quandary
5 Definitions of “Eclinical”
What “eclinical” should mean or might mean. An attempt at a definition. And a dietary adventure.
"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or "esource" could be on the grapevine this year, as sponsors scramble to determine if their systems comply with a new draft guidance from the FDA.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 December, 2010. (You can download it here.) There is nothing controversial about the guidance document. This is good. In an ideal world, people being regulated and the people doing the regulation should be on the same page. They should be working with the same concepts, the same basic understanding of the territory. Generally, in biomedical research in the U.S., the regulated and the regulators are in sync. But in subtle respects, the new guidance shows new thinking at the FDA. The agency is clearly redefining one of the most basic concepts in biomedical research. That could nudge the industry toward systems or practices it is not now using. It could also sow confusion. In the draft guidance, the FDA is…more...
Last Friday, we wrote up the recent Drug Information Association (DIA) presentation by Quintiles VP of global data solutions, Thomas Grundstrom. But the ground rules of the DIA meeting bar speakers…more...
Earlier this month, we ran a two-part series about electronic data from the perspective of clinical sites. (The stories can be found here and here.) The frustration at sites is real.…more...
With myriad industry efforts to accelerate study start-up times, one might think the process of hammering out contracts at the site level would now be speedier than, say, three years ago.…more...
Another Encorium deal has bitten the dust. The beleaguered contract research organization (CRO) recently announced that its recent attempt to sell its Finnish subsidiary Encorium OY to an unnamed CRO in the U.S. is scuttled. In a release, the company stated that, on the heels of $8.7 million in new business contract wins thanks to its selection…more...
Is electronic data capture (EDC) creating inefficiencies? That's one conclusion to be drawn from the interim results of an eClinical Forum survey. Surprisingly, the survey suggests that the use of paper case report forms (CRF) is rising even amid growing adoption of EDC. While most sponsors are committed to EDC, site staff believe it is forcing them…more...
It's a big day at contract research organization PPD (Nasdaq: PPDI). The Wilmington, N.C. company announced it's acquiring one company and selling another. In: Magen Biosciences, a biotech firm focused on dermatologic therapies. Terms: $14.5 million in cash. That deal continues PPD's strategy of owning compounds or splitting the costs and rewards of their development. Out:Piedmont…more...
Whatever happened to Oracle Clinical, the database firm’s flagship application for clinical data management? It’s still there. As we noted a few days ago on this site, some Oracle customers in the sponsor and contract research organization (CRO) community are starting to acknowledge their usage of the company’s technology. But the company doesn’t make as much noise…more...
What “eclinical” should mean or might mean. An attempt at a definition. And a dietary adventure.
A conversation with Denis Connaghan of etrials, who recently became the new CEO of etrials.
Glen de Vries of Medidata discusses the company’s effort to create an ecosystem for clinical trial software.
Chuck Piccirillo discusses the company’s strengths and current direction.
With a new strategy, publicly traded TechTeam Global begins angling for more clients that need computer support for clinical trials.
The debut of our list of suites—integrated technology firms or services firms providing at least three major types of research systems.
What’s different this year. Random thoughts on our personal nemesis, paper, and the alternative.
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