Late last week, DataTrak International reported a burst of new business from unspecified customers in the U.S. and Europe. In total, 18 new trials will use its eClinical suite. DataTrak is positioning that system as an enterprise-wide solution for clinical trials.

Our own visit to the suburban Cleveland offices of DataTrak was inspiring, but not just for what it told us about the Ohio company. Yes, we had a glimpse of DataTrak’s unified system and saw that it could do more than we thought.

Since acquiring ClickFind for $18 million early in 2006, DataTrak can offer a truly unified platform, not assortments of programs that have to be soldered together every time out of the gate. But on a larger level, we had a glimpse of sponsors and clinical investigator site personnel needing to do less clicking around between umpteen separate applications, websites and systems.

One System

The main elements of the DataTrak suite include: electronic data capture; clinical trial management; coding of adverse events; technology assessment of clinical sites; web-based patient randomization and interactive voice response; laboratory data import; digital images; electrocardiograms; and shared workgroup calendars and files for collaboration. Most customers, the company says, use EDC plus a handful of additional modules on an a la carte basis.

One of the most eye-opening features is its Data Architect, which the company website describes as “a spreadsheet-based design tool for nonprogrammers to configure electronic forms (e.g., data formats, dependencies, alerts, etc.) and generate the project documentation, XML code and SQL database configurations required for EDC.”

Much of what we saw was demo’d by Kathy Tibaldi, manager of learning solutions at DataTrak. She’s a former teacher who is now DataTrak’s top trainer. We may have been feeling a bit of wistful homesickness, visiting our native Midwest, but Tibaldi struck us as the sort of quintessentially straightforward, briskly efficient Ohioan who could make any esoteric topic seem simple, fun and interesting.

Workgroups

Collaboration and file sharing is built into the DataTrak suite. “If the clinical team all needed to share files or calendars, we could set up a work group that they could all share,” Tibaldi said. DataTrak is not the only company that sees the clinical trial workflow as collaborative, but it does place unusual emphasis on enabling multiple organizations and types of personnel that collect the data.

She also showed us an inventory module to manage drug supplies in a clinical trial. (As noted above, randomization and interactive voice response are under the hood.) “There is a nice easy link for the user when they receive their shipment to confirm the date and offer any feedback about damage or anything else,” Tibaldi notes.

As she demonstrated, the whole system is available from a single sign-on, all drawing on the same database. The user interface is simple, with small green and red squares indicating if a particular data element is open or closed.

No Aimless Clicking Around

Then it was on to the trial summary screen. It’s a well-designed, information-rich dashboard. “This is where I get the oohs and ahs,” Tibaldi says. “It really lets people see what is going on. It has everything people want to know without having to go look for it.” You can see a list of the most common queries, or specify any other desired report. One nice feature is a simple field that shows how old each data clarification or query is. There is a surprising amount of information about the trial packed into one screen, with easy ways to sort and reorganize what you’re looking at.

In some cases, a tab will allow fast access to additional information about a particular issue. The platform has an “alert manager” that allows sites to be easily queried within the system, which can generate queries in Adobe PDF or paper form in one click. Those queries can also be sent outside the system.

Easier Reports

Data can be locked at a variety of levels: the form, visit, or case book, among others. The data from case report forms can be exported into text, SAS, and spreadsheet formats.

As we were watching, Tibaldi used the system’s report generator. It’s a point-and-click way to assemble reports, adding and aggregating data elements, using filters to organize, include and exclude certain types of data. “Which site do you want?” Tibaldi asks. “It gives you a lot of flexibility. It can be very simple for the nonprogramming minded. It can also be very complex. We can work with someone in statistics and show them how to create body mass index formulas based on other data points. It can accommodate a lot of needs.”

Clean UI

But DataTrak’s system also allows more ready access to full-blown reports with a single click. This was impressive. “The idea of being able to report very easily and use hyperlinks to get back to the data—that’s a wow factor,” notes Marc Shlaes, VP of product strategy at DataTrak. “We get a lot of feedback that this interface is clean and simple and not cluttered with stimulus and sensory overload.”

Of course, no visit to Cleveland would be complete without a chat with Jeff Green, DataTrak’s president and CEO. Green thinks that even sponsors tightly linked to particular EDC vendors now could begin to consider alternatives when their existing contracts start to expire over the next two years.

Peering Ahead

He thinks that particular 24-month interval will be one of particular flux in the selection and rollout of EDC across the industry. Green is quick to concede a degree of similarity to every EDC solution on the market. But he believes a pretty short list of companies (his own and Medidata of New York) offer genuinely unified technology platforms. “Everybody else has pieces and parts that they bought and are trying to slam together,” Green says.

He is not a shy or hesitant fellow. “We know of no other provider in this field that has such a depth of unified offering,” says Green. He’s equally blunt on the need for sponsors of trials and suppliers to move toward shorter, sweeter contracting negotiations. He doesn’t think that technology suppliers should be treated to the same familiar hazing rituals that greet contract research organizaitons (CROs). Like some competitors, the services component of DataTrak’s revenue stream is increasingly important. A new DataTrak consulting division, for the moment unnamed, is being positioned to aid customers that have more extensive needs or are just getting started on the DataTrak platform.

The company is exploring expansions to its functionality. Research on helping customers issue electronic investigator payments and track sites, Green says, has begun. He readily concedes Phase Forward’s superiority in the analysis and detection of drug safety issues, but says DataTrak aims to beef up its pharmacovigilance capabilities, too. “Our plans to grow into that area of analytical assessment of signals will begin in late 2007,” he says.

DataTrak eClinical: The vendor challenges competitors to put all of the above data types into a single web-based application

Green is also proud of his platform’s ability to store and display images and electrocardiograms (ECG) within an EDC system. Tibaldi showed us that as well, showing built-in image-analysis functionality and using the system’s nifty Java applet to create a surface plot of a chest X-ray. “You can actually have an image and the clinical data in the same database,” notes Green. “We can run ECGs over the web in an ASP fashion so that they can be viewed and analyzed anywhere in the world. The ECG thing will grow because of the emphasis on cardiac safety from the FDA.”

DataTrak is rarely inclined to name customers, which makes it extremely hard for outsiders to evaluate how much traction their product has against large industry rivals like etrials and Oracle Clinical. But DataTrak has previously announced that COResearch will be using its suite. COResearch is part of Duke Medical Strategies and was spun out of the Duke Clinical Research Institute. Founded in 1983, with 15 million ECGs under its belt, COResearch would seem to know a thing or two about how to handle ECG data.

Consulting Push

One of DataTrak’s competitors that is well known for combining ECG data and EDC, Green notes, requires special hardware and still uses FedEx to move data around the world. DataTrak expects that some sponsors may want to have physicians in India or elsewhere read the web-based ECGs overnight for one-third as much money as such services would cost in the U.S. DataTrak recently visited a prestigious academic medical center and they were wowed by the image-handling capabilities of the system. That institution’s main question: “How do you do that?”

Green notes that the Galt drug safety system was purchased by Cerner, and predicts other point solutions will fade over time. “We were losing business because we didn’t have a coding engine as part of our product suite,” he says. DataTrak’s acquisition of ClickFind changed that, providing the unified architecture. “Many people don’t know how frustrated they are until they see the alternative,” Green says. “They just put up with it.”

As a result, new and existing DataTrak customers who migrate to the new platform won’t have to stitch different types of data together. Such systems, Green believes, will eventually be viewed as less desirable: “We have everything on the same screen.”

And for all of the similarities between EDC systems, Green thinks his is just a bit easier for nonprogrammers to use. “Everybody can create reports,” he says. “The question is how easy or difficult it is to do that.”