Part One
Sites+EDC=Pain
Why electronic data capture has lead to simmering resentment at clinical sites.
By design, electronic data capture (EDC) systems are utilitarian. Clinical data managers need a secure, electronic way to collect and change medical information. As such, EDC systems are about as scientific as a box of ballpoint pens. But that could be poised to change with the unheralded purchase of a small clinical trial technology firm in France. At the end of 2010, Merge Healthcare of Milwaukee, Wisconsin, bought Kika Medical of Paris for a net price of $2.03 million in Merge stock, once reserves for potential future litigation and other withheld shares are tallied up. Jon DeVries, general manager of the eclinical division at Merge, notes that Kika's EDC package includes the ability to adjudicate clinical endpoints. Although several technology firms and contract research organizations (CRO) can provide endpoint adjudication services, DeVries says that Kika's solution is uniquely embedded in an EDC package and comprehensive—wrapping up the process in an end-to-end…more...
In 2011, with electronic data capture (EDC) systems in broad usage, there is only one deep question about the technology that remains. To wit: should EDC be confined to merely gather…more...
It's a great debate, and far from over. Some analysts predict the large contract research organizations (CRO) will eventually manage the bulk of industry-sponsored research. Others predict that mid-tier and specialty…more...
In the short life of the internet so far, electronic data capture (EDC) came of age at an inopportune time. The top EDC solutions were born in the age of beeping…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...
At all large technology companies, innovation dies. Intel, Microsoft, Nokia, Intuit may claim to invent. But year after year, their ostensibly new products are indistinguishable from older ones. Could any ordinary human differentiate between phones or PCs from 2005 and 2010? Which are more glaring: the engineered security holes in Adobe's Flash plugin, or the file synchronization…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. 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…more...
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 indifferent to the operational problems created by such systems. “Sponsors and CROs really need to think about this,” says Christine Pierre, CEO of the 16-year-old site…more...
Why electronic data capture has lead to simmering resentment at clinical sites.
The eClinical Forum discusses why sites don’t like the technology the industry spends billions on.
A Memphis-based oncologist network is automating study start-up with its own document management system.
Our inaugural listing of the dominant firms supporting global clinical trials.
Two veterans of large CROs launch a small CRO for small to medium drug developers. And a CTMS to match.
Getting a high-grade clinical trial management system could be faster and less expensive than you expect, Clinical Force maintains.
With bulletins about Merck, Schering-Plough, DSG, Google, Facebook, U.K. drug safety effort.
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