September 3, 2010edc

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The Amazon Problem

An Eclinical No-Fly List

July 19, 2010

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. It’s deep. Given that industry urgently needs both EDC and clinical sites, the distress is likely to continue. None of the design constraints—on sponsors or on regulators—will mutate. Ever. EDC did not emerge in a vacuum. While serious, the concerns of sites are not of such magnitude to force slow-acting sponsors to switch EDC systems or redesign them. So the industry’s usage of a key research system is likely to be one of several grating, annoying factors that are accelerating the disengagement of U.S. biomedical scientists from industry research. Which is sad. Some industries facing such an issue would scramble to take action. Tech Gap In pharma, oddly enough, other eclinical systems are even harder to use than EDC. Some…more...

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Part Two

Site Pain With EDC

July 09, 2010

Investigator sites accept the need for technology like electronic data capture (EDC). But they remain puzzled about why some problematic EDC solutions are selected by clinical trial sponsor firms that seem…more...

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Part One

Sites+EDC=Pain

July 08, 2010

Electronic data capture (EDC) systems allow sponsors to gather data electronically. In theory, that should be cheaper and faster. After a decade of gradual acceptance of the technology, all sponsors have…more...

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Exclusive: Survey

More Paper, More Burden?

October 19, 2009

Is electronic data capture (EDC) creating inefficiencies? That's one conclusion to be drawn from the interim results of an eClinical Forum survey. …more...

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Titans In Services, Tech

2009 Master Providers

May 05, 2009

Public or private. Contract research organization (CRO) or technology vendor. If a company specialized in supporting clinical trials, we considered it. It's no surprise: Quintiles is at the head of our inaugural list of the industry's pre-eminent clinically focused outsourcing firms. Most are CROs, but we've also included a handful of leading technology companies because they are…more...

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Beyond Spreadsheets

Clinical Force: CTMS as SAAS

March 19, 2009

Even in 2009, in a context of clinical trials, "management" can mean just about anything. It may mean ... Karen, three cubicles away. Or a 5-year-old spreadsheet. Or a system that cost millions but sits unused. As a result, it's fair to say that clinical trial management systems (CTMS) do not enjoy a reputation for easy implementation,…more...

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Defending The Cloud

U.K. Drug Safety Effort

March 09, 2009

Is this the year for mega-mergers? Merck will buy Schering-Plough for $41 billion in cash and stock. Merck had perennially insisted it would never merge or acquire rivals. But evidently the appropriate size of the industry's largest firms is changing. Merck and Schering-Plough will have roughly $42 billion in annual revenues between them. That is approximately two-thirds…more...

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Physician IT Links

Nextrials On The Move

March 05, 2009

For a large fraction of the clinical trial community, clinical data standards are like 1,200-page Russian novels. People claim to read them but seldom do. For electronic data capture (EDC) supplier Nextrials, however, standards are competitive weapons to showcase its strengths. This does not mean that Nextrials is brandishing anything. The firm is too nice. And standards…more...

EDC, CTMS, IVR

i3Cube: Trial Swiss Army Knife

i3 Global, a CRO, has made a major investment in eclinical technology. Its system could replace four or five pieces of software.

Parexel, Phase Forward

Two Giants Grow

The two Boston-area firms appear headed for a more intense IVR rivalry.

Webinar, New Guidance

EDC Is Dead? Long Live EHRs?

Thoughts on a potentially transformative alternative to EDC, the electronic health record (EHR).

'We'll Be #1'

Oracle Eyes Resurgence

Patti Devereux Gaves says Oracle Clinical’s low profile in the eclinical space will soon change.

Dictionary Quandary

5 Definitions of “Eclinical”

What “eclinical” should mean or might mean. An attempt at a definition. And a dietary adventure.

Reorg, New CEO

etrials: Technology Will Be Key

A conversation with Denis Connaghan of etrials, who recently became the new CEO of etrials.

Magic Pen

Kayentis: Back to The Future

From France, a hybrid system that uses special paper and a scanner-pen to gather clinical data.


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