Part One
Sites+EDC=Pain
Why electronic data capture has lead to simmering resentment at clinical sites.
Since time immemorial, sponsor firms have chosen software. Then it gets introduced, so to speak, to the throats of research sites. Sometimes principal investigators and clinical research associates (CRAs) like the technologies they are obliged to use. Sometimes they just use them. So it is remarkable that Greenphire has industry-savvy research sites knocking on its door with no mandate or funding from sponsors. Ten major academic medical centers (AMC) and a hundred independent clinical sites have called Greenphire and said, more or less, "we'd like to pay for your services with our own money." In a context of industry-sponsored trials, that's unheard of. Even small, independent Phase I units have taken the initiative to seek out Greenphire's solution and buy it on their own. Unified Approach ClinPage wrote about Greenphire more than two years ago, but the company's services and operations have since expanded. It launched a full-featured system to handle…more...
One way to view the media landscape in 2011 is as a society-wide clinical trial for attention-deficit disorder in which 90 percent of the U.S. population has voluntarily enrolled. Working, walking,…more...
When it comes to finding patients, the clinical site universe is starkly partitioned. Perhaps one clinical site in twenty is superb, reaching difficult patient recruitment goals. Such sites make industry-sponsored research…more...
In a new survey of 598 investigator site personnel, there is an unhappy snapshot of the most oppressed and disgruntled segment of the clinical trial workforce. According to the survey, clinical…more...
IntraLinks is a document management firm with a focus on financial services and life sciences—regulated industries that move around electronic and cellulose-based forms. The New York City company is betting that some forward-looking research organizations will want to manage documents in the cloud. Last week, IntraLinks announced tweaks to an existing product that make it, for lack…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...
The recruitment of minority patients is hard under any circumstances. But finding research subjects for conditions with a social stigma is especially difficult. Barbara Gladson is director of the biopharma educational initiative at the University of Medicine and Dentistry of New Jersey (UMDNJ). She gave a fascinating presentation on her work at the 2010 annual Drug Information…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.
A harmless-looking legal concept—cross indemnification—could hurt sites.
The Alliance for Multispecialty Research is a large-scale, collegial and independently owned site network.
Veterans like to participate in clinical trials, and a top California site knows how to ask.
Frustrated with checks, one site has turned to rechargeable debit cards from Payoneer.
An annual conference enables clinical site leaders to compare notes and share business practices.
Norman Goldfarb discusses recent industry trends and his upcoming conference in Boston in May.
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