Thermo Fisher Scientific and Quintiles Transnational announced the creation of a joint venture, Cenduit. It will provide seamless, integrated interactive response technology (IRT) services during clinical trials. IRT is a technology platform that integrates patient interaction systems through a combination of telephone response, web interface and handheld electronic patient diaries. “Our companies have been looking for an opportunity to leverage the particular service strengths we bring to the drug development process,” said Marijn E. Dekkers, president and CEO of Thermo Fisher. “With Cenduit, we have combined two leaders—the clinical supply chain expertise of our Fisher clinical services business with the clinical development expertise of Quintiles—to offer a scalable, seamless technology platform.”

CDISC sets the technology agenda in clinical trials. The organization is now urging companies that have not joined to do so—and existing members to chip in more. It is a highly laudable endeavor. If your employer is not on this list of CDISC members, it should be. Questions? Contact
.

At the American Telemedicine Association show, IBM announced its new grid medical archive solution (GMAS), a cross-IBM offering comprised of storage, software, servers and services. The GMAS solution provides hospitals, clinics, research institutions and pharmaceutical companies with a multi-tier, multi-application and multi-site enterprise storage archive for delivering medical images, patient records and other critical health care reference information on demand.

etrials, a clinical trial suite, has booked two new projects with two new contract research organizations (CROs). Of the two newest partners, one is a large firm with operations worldwide and the other a small specialty firm specializing in the central nervous system therapeutic area. Also in the second quarter, etrials booked two additional projects from an existing CRO partner with a focus on the central nervous system, representing the third and fourth projects with the same CRO in the past six months. In aggregate, these four new projects, expected to run from as short as six months to as long as seven years, are valued at approximately $1.2 million and include both electronic data capture (EDC) and e-diary software and services in trials at over 100 sites throughout the U.S.

Inclinix has unveiled its updated web site. “Our updated site is designed to assist pharmaceutical, biotechnology and medical device sponsor organizations, and clinical investigators in understanding our proven processes and technologies for successfully enrolling clinical studies,” says Bill Gwinn, vice president of product marketing. “The site also provides insight into our company and the people behind our enrollment solutions.”

VirtualScopics, a developer of image-based biomarker solutions, announced that it released its next generation 2.0 software platform for the use of imaging in clinical trials. This industry-leading platform draws upon seven years of experience in imaging to deliver operational efficiencies and enhanced reporting in order to expedite customers’ clinical trial process. The new platform provides FDA required 21 CFR Part 11 compliant tools for managing international imaging sites. These latest capabilities give VirtualScopics a scalable global reach that is essential to conducting later stage clinical trials. The software platform includes a new image analysis automation system, improved traceability, enhanced tools for data management, in addition to real-time detailed reports for VirtualScopics’ customers.

Xiaochuan Wang, chairman and CEO of Sundia MediTech Company (Shanghai), joined Xiongwei Shi, CEO of United PharmaTech, and Xuehai Tan, CEO and president of HD BioSiences, in announcing the formation of a new contract research organization (CRO) service alliance (CROSA) in Shanghai’s Zhangjiang HiTech Park. This CROSA, formed by three leading CRO companies is a first for China, and will take the advantages of specialized expertise from the three CRO companies to provide efficient and high quality CRO services ifor drug discovery and development of clients.

Finally, three items about Avandia, the blockbuster GSK diabetes drug:

1. Hoping to calm the waters, FDA commissioner Andrew von Eschenbach published an op-ed in USA Today. “About a year ago, we warned about this possible risk in Avandia’s labeling. Since receiving additional information from Avandia’s maker last August, FDA has been analyzing data from 42 previous studies in detail, expanding on the work done by the drugmaker. We have been working to obtain and analyze data from other studies, some of which appear to contradict the findings of the earlier 42 studies,” von Eschenbach writes. Hmmm. In time, these not-yet-published “other studies” could serve as the FDA’s much-sought get-out-of-the-Avandia-doghouse pass; they could allow the FDA to take additional action based on something besides a) the recent New England Journal of Medicine article or b) what GSK previously told the agency.

2. GSK attacked the news media for inflating public concerns about its product. U.S. politicians, meanwhile, are whispering that GSK silenced internal medical staff worried about the drug; the company denies the allegation. The Lancet called for a judicious examination of the facts.

3. John Buse, a professor at the University of North Carolina, identified elevated cardiovascular risks with Avandia seven years ago. He brought them to the attention of the FDA and was brushed off. Buse’s now uncertain about the risks posed by the drug, however. The Wall Street Journal has published snippets of Buse’s correspondence. Our guess is that that correspondence will be damaging to GSK and the industry if it is ever published in full. Buse will be both easy and hard to impeach. He was working as a consultant for GSK competitors at the time of raising the initial alarm about Avandia; but he’s also the president-elect of the American Diabetes Association.

Have a news release? Send it to .