We were in Dallas last week. The 2008 Society for Clinical Data Management (SCDM) conference presented an award for “data-driven” innovation. The format of the award is to assess what a technology vendor and a sponsor firm can do together.

The 2008 winners: Arrowhead Electronic Healthcare and Bayer Healthcare. They’ve been working together since 2001. This project had an eight week timeline. The challenge? To ship devices in 19 different languages, including Russian, Hebrew and Arabic. Some of the devices had to ship in six weeks.

The global scope and sheer complexity of the patient-reported outcome (ePRO) study created challenges for the Austin, Texas ediary firm. There were 142 forms for patients in each of the 19 locations. That works out to a total of 2,698 forms to inspect for regulatory and quality-control reasons.

Just managing the process of language translation can be a challenge. Then there is the matter of how to let all of the necessary stakeholders see all of the screens on all of the devices.

Global Deployment

So Arrowhead created what it calls a “Dumb Monkey.” It’s software that will be available to other customers as well. In an automated way, it randomly visits each computer screen programmed into the patient diary, and snaps a digital picture. In every language. One screen at a time, it meticulously keeps recording the screens until every last one of them has been captured for review.

“You have to have the actual screen shot,” says Arrowhead’s president, Jeff Albrecht. “That helps us validate there are no missing links or images. It makes it easy for lots of people to see it.”

Saving Time

In the past, the quality assurance method was labor-intensive. Microsoft Word and Visio documents were slowly filled, one image at a time. Or humans had to tap carefully through each screen in the study.

Arrowhead’s Jeff Albrecht and Shae Wilkins at SCDM

But as ePRO trials get more complex, launching in more nations, manual methods to double-check the final product have to evolve. The Arrowhead “Dumb Monkey” also helps test the logic by which patients move from one question to the next. It can compare the sequence in the software to the sequence in the trial requirements document, noting discrepancies. That process used to take hours; it now takes seconds. Overall, Arrowhead estimates, the software probably saved about 500 hours of work.

On top of that, there is the relief factor—the knowledge that in the rush to get the devices to the sites, nothing was missed. “It gives us additional confidence,” Albrecht says.

Editor’s note: Last year’s SCDM award was won by DSG, a Philadephia provider of electronic data capture.