There is scarcely a more tired phrase than “it’s not rocket science.” But what if electronic data capture were conceived as something that had to be as robust as the software to protect astronauts or Navy pilots?

That seems to be the approach of Prelude Dynamics, a Texas startup with more than a dozen employees and active projects. Two of those (at Johns Hopkins and the University of Pennsylvania) are sufficiently prestigious to suggest the company has technology to be taken seriously.

Data Cockpit

Prelude is aiming to be a contender in a robust electronic data capture (EDC) sector. The company’s solution combines EDC with clinical data management, clinical trial management and drug supply management. Its executives understand the requirements of the space and are not intimidated by them.

“With the NASA systems and the Department of Defense, there was a heavy, heavy emphasis on the rigor of the system and proving that it does its job accurately,” says Richard Tieken, co-founder and president of the firm. “Knowing what is happening with the patients as a whole, and the trial as a whole, is important and hard to get without the support of an automated system.”

Tieken’s roots are in the space and military-software sector. He worked on the shuttle, missile defense and a variety of Navy and Air Force programs.

Competing On Cost

Like most smaller EDC providers, Prelude will compete on cost, noting that studies can be built for $50,000-$100,000. “Our pricing is pretty straight forward,” Tieken says. “Once we give a quote, we stand behind it.”

“We just did a study of 135 patients, 35 unique case report form pages, for $80,000,” he says, plus a nominal monthly fee for ongoing support. One of the reasons for the low cost is that the technology allows changes to be made more quickly. With a native XML database, he says, his system makes it easy to add a field. Not, in short, something for which Prelude charges thousands of dollars.

Avoiding Info Overload

Aside from its stability, Tieken says his system has another parallel with the world of military systems. Clinical data overload is a potential risk from a human perspective; computer systems should support expert decisions without providing a bewildering amount of information.  “You’re getting lots and lots of data,” he says. “You need that. But you can get lost in the data. You can get overwhelmed. You still need to be able to think about what sense does all this make?”

So Prelude Dynamics endeavored to create an especially elegant, easy-to-use interface that is simple enough to access and run on an iPhone.  One of the more eye-catching features is what the company calls “Viewport.” It’s a desktop widget, i.e. not even as complicated as a full-fledged program. According to Tieken, it “allows users to stay up to date and in touch with their study/trial events without having to log-in and check progress throughout the day.”

Trial Ticker

The Viewport can be compared to a stock ticker that shows key metrics as they change. The sponsor can determine what needs to be tracked. If the status of a form changes, if an enrollment milestone is reached, if a value is out of range, if an adverse event is recorded, the Viewport can display an alert. “We can notify about changes made to a field if desired,” says Tieken. Clicking on something in the Viewport opens up a web browser and brings a project manager, say, to the page where some response is required.

Prelude is trying to work within the work flows of the industry but be as mindful as possible of the burden on clinical sites. The forms that a clinical research associate must complete can vanish—in a good sense—when a particular answer to a different form indicates that such a form is not needed. “I don’t think anybody does that,” says Tieken of competitors.

The Prelude system also supports imaging, and integrates images into case report forms. In a trial of oral warts, the software can map the warts on a diagram, and allow the investigator to record if they are still there on a later patient visit. In another example, for orthopedic surgery, his system can allow the surgeon to record a knee’s range of motion with a mouse, not a pen and pencil.

EDC & More

His system has some functionality that is more typically found in clinical trial management systems. “The CTMS features are there, but not in a module they have to pay extra for,” he says. It is not a full-featured CTMS, he concedes, but does more than some EDC systems, with reports and filters for any variable in the system.

“There are site regulatory tracking features, screening/failure summaries, enrollment metrics, randomization, site payments and drug inventory controls,” says Tieken. “If the sponsor has set up a site form to include, for example, site open/close dates and expected enrollment, the system can graph the actual (or average) enrollment across time with a comparison to the expected value.”

Tieken notes that the system is counting just about everything. “If the sponsor wants to know, we can tell them how long the investigator visits a case report form page, or a contract monitor, along with how a site’s averages for queries compares to another site’s,” Tieken says.

Prelude’s arrival raises a familiar question for the EDC landscape. At what point will the universe of companies supplying this technology be sufficiently intimidating to discourage new entrants? We’re not there yet.

But the financial momentum and operational skills of the top dozen EDC providers have created a challenging environment for younger EDC firms with good ideas. The willingness of sponsors and CROs to continue to test the technology of more recent EDC entrants will be one indicator to watch in any assessment of purported vendor consolidation in the sector.