(12/22/04)—There are those who believe electronic data capture (EDC) is best applied to late-phase clinical research, in trials in which thousands of patients are enrolled. Some clinical technology vendors readily concede that the startup process typically involves so many special requests from sponsors that it almost pays to do paper for Phase I studies.

Logos Technologies has a different perspective. It captures all its data electronically. That means the technology has to be ultra-reliable, as some Phase I studies last only a day – a system that was down for a morning would be highly problematic.

The 10-year-old London company has 20 employees and specializes in Phase I and II-a trials. Perhaps half of its business is in the U.S. Giles Wilson, business and operations director, is one of the founders. He notes that the company had a bit of a learning curve because, until recently, it sold its technology to sites, not sponsors.

That stage of the company’s development allowed him to receive more than a few earfuls of input from people in the trenches, he says. But over the long haul, it paid a dividend. “We’ve got an investigator-friendly system,” notes Wilson. “It adds value and makes life easier for the investigator. It’s often meant we haven’t got sales, because they haven’t had the budget.”

But the kinks are out of the technology, he says, and now big companies such as Eli Lilly (in the U.S. and Singapore) are repeat customers. Just last month, the contract research organization Kendle International bought an enterprise license for Logos’ Alphadas Clinical Data Management and Phase I Site Tool Kit solutions.

One of Logos’ chief advantages, says Wilson, is the software’s ability to serve as a stopwatch, counting down to the exact moment when blood should be drawn or a measurement recorded. “In Phase I, time is critical. It’s important you don’t miss data and you take it on time,” says Wilson. “Nurses in a Phase I will be looking at the clock, and watching the software count down from 10, 9, 8 . . . . ”

Beyond that, his software is smart enough to know that if a nurse gets 10 minutes behind, everything else that day will also be delayed. Instead of forcing clinical staff to manually recalculate each frame of an Excel spreadsheet, the Logos system automatically generates a whole new schedule. “They like to see that there is a conflict, and then they sort it out themselves,” Wilson says of clinical research associates.

The software is expressly designed for ordinary mortals – not IT departments. “Our setup tool is a point-and-click tool that anyone can use,” says Wilson. “It’s not a developer’s tool. You can put a study together in a matter of hours. It’s not a long, slow process.”

Data can be entered offline, and later uploaded and synchronized. Browser-based EDC systems, he says, are not suited to Phase I. That’s because a computer that is down even for an hour could be highly disruptive. Fortunately, however, once the data are in the Logos system, they can be reviewed using a Web browser.

Another feature: direct interfaces with common clinical instruments on both sides of the Atlantic. The software connects with a variety of devices, including the Cardiovit AT electrocardiogram machine from Schiller, the GE Dinamap blood pressure monitor, and the Sartorius line of scales to weigh patients. Says Wilson: “Our software will tell the blood pressure apparatus to pump up at the right time. The nurse comes along and signs it with an electronic signature. It’s taking data directly from the physiological devices. We’re removing the inaccuracies that can happen.”

To address the industry’s ongoing concerns about small vendors, Logos has an arrangement with the National Computing Centre in England, which will safeguard the company’s application and source code safe in case of a dramatic change in the business.

On an encouraging note, Wilson says that some sponsors he encounters are a bit less interested in their own systems of late. “Companies are now actually looking more to vendors rather than continuing to develop their own systems,” he says. “That’s the biggest pick-up. They’ve had the experience, they’ve tried it themselves. They recognize the costs of doing their own systems.”

This article first appeared in the eCliniqua newsletter.

For further information please contact the Logos Technologies Press Office by emailing press.office@logostechnologies.com