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Data delivery paradigm shift
NEWTOWN, Pa.—The manner in which image data for clinical trials is delivered to medical researchers—on CDs via FedEx or other global courier shipments—has come to be accepted as a necessary evil, but Bio-Imaging Technologies Inc. has inked a deal with global diagnostic imaging network AG Mednet in the hopes of shifting that outmoded paradigm to a more efficient model.
The partnership will trade the "snail mail" manual transport systems commonly used in imaging trials for a Web-accessible, secure network between clinical sites and Bio-Imaging's Imaging Core Lab (ICL). At the investigator site, a Web-enabled agent will guide trial managers through a process to send the image studies and data directly to the ICL. The process typically takes minutes, compared to previously used methods that have taken hours or days, and is expected to reduce the costs associated with shipping, says Bio-Imaging CEO Mark Weinstein.
"This partnership increases trial efficiency with faster delivery of the imaging data, enhances data quality with fewer site queries and reduces cost versus today's standard global courier shipments," Weinstein says. "As Bio-Imaging can manage all of the logistics to centralize radiologic data and provide expert independent review services for Phase I-IV clinical trials, we now provide a one-stop-shop for today's medical researchers."
To transfer images, investigator sites will access a desktop agent via the Internet that will give them access to the clinical trials imaging network and an easy-to-use workflow tool to quickly import image studies, de-identify image studies, complete transmittal forms with full validation of protocol-specific requirements and then send the image studies directly to the appropriate trial repository.
AG Mednet President and CEO Abraham Gutman, a self-described "telecom geek," likens the new process to a multi-line telephone network: "We have the capability to inject data into the network, like making a phone call, and people have a way of getting it off of the network, like receiving the phone call," he says.
The file sizes Bio-Imaging deals with are very large and complex in structure, and many people have tried to use FTP systems—with little success—to send them, Gutman says.
"FTPs have been around since the late 1960s and early 1970s, so if that was the answer, people would still be using it," Gutman says. "But using envelopes also has a lot of issues. What we do is completely automate this process so Bio-Imaging's clients can use this Web-enabled software to send images, fill out their transmittal forms and de-identify the data. It then goes directly into Bio-Imaging's repositories without human intervention. This not only reduces costs, but it may also take the time it takes to get through trials, not to mention our carbon footprint is a lot smaller."
Because Bio-Imaging receives study-related data from more than 11,000 sites and 80 countries, the company expects that adoption of the new process will take time, Weinstein says, so Bio-Imaging will test the new process with a few clients.
"Courier services are still going to be a standard way of sending imaging data for a long time, because like everything in health care and research, it's not a technology problem, but an adoption issue," he says. "We're hoping that the work AG Mednet has done to simplify the process will allow that piece of it to get traction." DDN