Is the industry ready to handle digital images by the gigabyte, linking them to other clinical trial data as a matter of routine?

Bio-Imaging must have considered that question when buying Phoenix Data Systems for $24 million earlier this year, as did Parexel International when luring image czar George Mills from FDA.

Now Phase Forward has stepped into the imaging arena, inking a deal with AG Mednet that will combine its electronic data capture system with an imaging platform.

AG Mednet is an image-transfer specialist. It emphasizes the ease and reliability of its network. The firm says it easily zaps the most mammoth radiological images from one hospital to the next and can’t be tripped up by the obstacles of FTP, HTTPS, or incompatible DICOM flavors.

Images Inside EDC

At Phase Forward, VP for corporate development Martin Young says that it will be possible to manage the image workflow inside InForm, his company’s flagship electronic data capture (EDC) system. Says Young: “You can go into InForm and see the status of where something is. Has it been done? Has it been reviewed?” Not forcing users to log into a second system to process trial images is an advantage, he says, and it was not particularly difficult to connect the two companies’ technologies.

While his and other EDC firms have previously combined medical images and other trial data, Young says, AG Mednet may bring sponsors something new—the ability to work with an unlimited number of images per patient, even with files of staggering size.

“This is stuff people definitely want to do now,” Young says. “What happened over the last four years is that the field has accelerated dramatically. The size of the scans can be huge.”

For many trials, images are already so large that it can take 30 minutes to transfer them using the internet. Sometimes that transfer is not successful. Reliable statistics seem scarce, but perhaps five or ten percent of clinical trial images may be transmitted electronically. As a workaround, technicians routinely burn a CD or DVD of the images, and call FedEx to deliver the disk, not to mention a scrap of paper identifying the patient. 

Virtual Courier

Which is where Abraham Gutman comes in. President and CEO of AG Mednet, based in Boston, he’s a telecommunications guy. “I am unencumbered by knowledge of health care, which has been a great benefit in building the network we have built,” he says modestly.

“When I first had this Eureka moment about building the network, I did not know how important this would be in clinical trials,” he adds. Even so, Gutman believes, industrial-scale integration of radiology and ordinary case report forms (CRF) has not been routine to date. “We didn’t invent image transfer,” he explains. “We guaranteed delivery.”

The company is four years old, with 400 hospitals or radiology departments using its system. The network is sufficiently fast and reliable to allow teleradiologists at the Brigham and Women’s Hospital to advise colleagues from all over the state of Massachusetts on an emergency basis. Indeed, as Gutman talks about the nuances, it’s clear that medical image delivery is an engineering art unto itself.

This is not to say everything is peachy. During a certain percentage of old-fashioned image transfers, expensive scans may go missing or detach themselves from the data surrounding the patient, like socks mysteriously losing their mates in a clothes dryer. It’s a rare but not unprecedented event. “I have seen it happen in clinical trials,” Gutman says ruefully. So AG Mednet developed a transmittal form with patient demographic data that is irrevocably attached to an image or set of images.

A Guarantee

Anyone can send a single image, he says. But technical chops are required to move large numbers of the largest files reliably. That dependability is an especially critical issue in a clinical trial with sites spread out over the globe.

If a FedEx arrives from Hungary with a CD of medical images, the patient is long gone. It could be days or weeks before a sponsor recognizes the wrong images were snapped. “In our case, they immediately know if the thing was wrong,” says Gutman. “The core lab, if there are problems, can interact with the sites very fast and correct the errors.”

The state of the art at many industry-friendly core imaging labs, Gutman reports, can be chaotic. Hundreds of overnight envelopes with CDs and DVDs may arrive each morning. “They have to open them and get the images off the CD, which is not easy because you don’t know which PACS created them,” says Gutman.

Rapid Reads

So to facilitate easy viewability, AG Mednet’s system doesn’t compress images according to any proprietary formats; those might make it harder for a radiologist halfway around the world to read the image.

This practice of FedEx’ing physical disks of patients’ scans? “Coming where I come from, it is more than hilarious,” says Gutman. “It’s like instead of sending you an email, I used a telegraph.”

In building his company, Gutman assembled a high-speed network that relies on software and wide data pipes. But from the start, he anticipated the mundane challenges of radiology technicians and clinical trial staff, who have more important things to do than wasting an hour on what amounts to babysitting a single image transfer.

Easy Install

“Clinical research associates are very busy,” he says. “They have a lot of demands on them. The last thing they want to do is nurse a file transfer. We need to guarantee that once we get the exams, once we have it, we will deliver it and they can forget about it.”

AG Mednet has its own computer protocol to move images. That circumvents FTP, firewalls, virtual private networks and all the rest of the IT obstacles present in the modern academic and community hospital. The company can transmit ten gigabytes per second at the moment, but will add additional capacity as necessary.

Most investigative sites use special software from AG Mednet, with no special hardware required. Core labs, however, can utilize a special networking device (a box, speaking casually) from the company. The box configures itself once it’s been connected to the local area network (LAN). The company has boxes all over the world. “We have never sent anybody to those places” to install the box, Gutman notes.

Picture Phone

Impressively, Gutman’s network does not care what format or modality or technology created the images. So a relatively novel imaging technique such as intravascular ultrasound (IVUS) is no problem. IVUS is more or less a Hollywood-worthy look at the inside of your arteries. “It’s movies,” says Gutman. “The files are just unbelievable. They don’t fit on a CD. We made it possible to move these things.”

In addition to monitoring the imaging process inside an EDC system from Phase Forward, AG Mednet can let customers track and audit what happens in the system under 21 CFR Part 11. AG Mednet will soon have the ability to deliver all of the images for a trial to the FDA, should that be required. Finally, in addition to sending the images to a sponsor, his system can automatically carbon copy all of a trial’s images to supporting organizations, such as an archiving facility, contract research organization (CRO) or third-party radiology practice.

“More and more trials are using imaging as part of their data collection sets,” says Gutman. “As this data is being moved electronically, we want to become a key player. We have built, essentially, imaging dial tone.”