GSK Picks BioClinica’s Randomization System

As posted on Clinpage.com

December 20, 2010

Inc. Research moved its headquarters to a new 120,000 sq. ft. location in Raleigh, North Carolina. Said CEO James Ogle in a press release: "This move better positions us to accommodate future growth of our clinical trials outsourcing services."

The FDA awarded a five-year data conversion contract to Octagon Research and ScenPro. The latter two companies will help the agency convert old FDA data to conform with Clinical Data Interchange Standards Consortium (CDISC) guidelines in an electronic age. Said Michael Gately, president of ScenPro: “We are excited about the opportunity to leverage our expertise to help the U.S. FDA broaden their use of data standards throughout the agency.” Here's a release.

Belgium's Unithink, an eclinical technology supplier, hired a new CEO: John Cline. The charismatic Cline was one of the earliest proponents of integrating multiple types of systems for clinical trials; he founded etrials (a precursor company within Merge) and guided it to a spot on the Inc. magazine 500.

That whole push to electronic health records, even with tens of billions of dollars in federal subsidies, is apparently not going so well, with adoption rates still below one quarter of all U.S. physicians. There are also isolated reports of serious medical errors and even deaths attributable to EHRs. Now federal regulators are considering the radical idea of regulating the systems. Any rules will probably take a few decades to implement, but vendors are still worried. "The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive VP of Epic Systems. You read it here first. Electronic health records are a 21st century version of the metric system—a global norm that a fragmented, Balkanized U.S. won't be able to build correctly.

Although the recent financial reform legislation was almost entirely an empty act of theater, it did apparently contain one provision of concern to many industries. Congress increased the payouts to whistle blowers who help federal prosecutors sue large corporations. That's part of a trend of multinational employees talking to government officials instead of facing internal corporate retaliation. The phenomenon is especially common in pharma; the New England Journal of Medicine estimates the median recovery to be $3 million. James Wetta of AstraZeneca collected $45 million for spilling the beans on his firm; GSK's Cheryl Eckart will receive at least $96 million. In some cases, employees become whistle blowers at several firms sequentially, a testament to the sharp-eyed folks in the human resources department. Here are a newspaper story and a blog post.

GSK signed a multi-year contract to use a new randomization system from BioClinica. The technology will be used in all phases of research, a sign that GSK believes it should help in small and large trials alike. The new system will replace an in-house technology at GSK and allow nonprogrammer trial personnel to set up the randomizations for their own trials, without relying on overworked contractors specializing in the task. BioClinica's technology assigns patients to treatment arms and also manages drug supplies. (An October, 2010 ClinPage article is here.) The award was snatched from under the noses of a) the most established randomization supplier with a large British footprint and b) the largest U.S. database giant, which purchased multiple randomization solutions earlier this year. GSK was an early proponent of rolling out electronic data capture (EDC) in a big way, and it will be interesting to see if BioClinica's system heralds another, similar shift away from 1970s-era interactive voice response (IVR) systems and toward faster, more user-friendly software that still connects to the telephone network when needed. Here's a release.

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