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By Mark D. Uehling

March 17, 2004 | Selecting an electronic data capture (EDC) vendor makes buying a pig in a poke seem worry-free. One can see if the pig has four legs. With clinical trial software, defects may not be revealed for years. Peering into the clinical poke, Forrester Research last month published an analysis ranking eight major EDC vendors on 160 criteria.

The new report analyzes applications and companies seldom compared to each other comprehensively. Senior analyst David Shiple didn't declare outright winners. (That may come in another report, with more vendors, due later this spring.) For now, it's clear that barriers to entry in EDC are surprisingly low. "You'll probably see more vendors, not fewer," Shiple says. "It is bad news for the sponsors," worried as they are about the financial strength of tiny software companies, often running on funds from venture capitalists.

While most EDC vendors seek the favor of the top 50 sponsors of clinical trials, Shiple says the juicier market may be the next 450 sponsors: "If you gave them an extra capability, like safety, a portal, and other clinical data management functions, you should be very strong," he says.

Individual vendors are likely to dispute the methodology of the Forrester study, which often juxtaposes well-established companies with fragile startups boasting a single customer.

Following are Shiple's top-line assessments of the eight selected vendors:

Phase Forward
"Clearly the market leader, with 300 clients, 70 of which have the EDC front end. But Phase Forward has the perception, among some, of having low responsiveness to customers and of having to jump through hoops to make its acquired Clintrials system talk to its internally developed InForm product. Customers looking at Phase Forward really need to get contractual assurances the interface [between the two applications] works," Shiple says.

Oracle Clinical
Shiple says there are 210 customers for Oracle Clinical and 20 for its bundled EDC application, Remote Data Capture (RDC) 4.5. "They already have 10 big customers that are installing and validating RDC 4.5. Three of those customers are in the pharma Top 5." Does a company of Oracle's size really care about clinical applications? "If you're Oracle, you can go buy PeopleSoft, you can get distracted. You can do lots of things and take your eye off the vertical. But for now, they've shown a good commitment to the pharmaceutical space by building what is really a substantial leap forward: RDC 4.5."

Medidata
"They've only been around since 2001, yet have the largest installed base of any company we looked at - 26 [EDC customers]," says Shiple, who notes the company is morphing into less of a standalone EDC vendor and now helping customers track adverse events and manage data using the same Web-based application. "They're very strong. You do have to have some programming skills to build their studies in their current version. The next version requires almost no programming skills. Their new version is also coming out with more clinical data management functionality and stronger reporting functionality. They don't have the global deployment of DataTrak and other companies, however, having only done studies in seven countries."

eResearch Technology
"ERT does not have as large a professional services division as Phase Forward, has not deployed as globally, and have on average smaller customers. They don't have quite the presence. But they have a nice system. They have been around since the early '90s. They have 110 suite users. Of those, 65 use their EDC tool. It's a nice percentage. You're comparing their $22 million in revenue for the clinical trial business vs. Phase Forward's $60 million in revenue," Shiple says.

etrials
"etrials has one of the largest installed bases, with 21 customers," says Shiple. "They acquired Araccel Corp., which basically gave them a couple customers. They're very solid. They have two of the top biotechs. They do require a proprietary browser. You have to go to the IT department at your site, and say, 'Hey, we're going to install something new on your machine.' It's usually not a problem, but if you're worldwide and someone has Netscape on a machine, this might be that one little extra burden you're putting on them."

DataTrak
"DataTrak differentiates itself in two key ways," Shiple says, noting the application service provider has done studies in 43 countries. "It's the only vendor that uses Citrix. That gives them very good response time, even for building the studies. Even on low-speed lines, they get excellent response times. Citrix only sends the data that changes, not the whole HTML page. It's also highly visual, icon-oriented, so it's easy to learn. It integrates well with clinical suites like Oracle Clinical and Phase Forward. But they're not going to have another major release anytime soon."

DataLabs
"They could be a Microsoft poster child. They are very buy vs. build when it comes to components. If they need something to handle XML transactions, they use [Microsoft] BizTalk. If they need a portal, they use [Microsoft] SharePoint. It's all object-oriented, which implies it's extensible. So if you wanted to grow with your vendor, and have some say over how it's extended in the future, DataLabs might be a nice choice. Granted, they're small. But they have a ton of learning from Merck," Shiple says.

LifeTree
"LifeTree is a fairly small company," Shiple says. "They have 10 customers. Those customers are small themselves. They do everything in the ASP model. They build all their studies for their customers. Their coding language is Javascript. They're a very savvy, conscientious company. They really want to make this work. LifeTree is differentiated in that it produces data files that can be ported directly to Integrated Review [Integrated Clinical Systems, Stockton, N.J.], a very sophisticated clinical trial data analysis tool."

Shiple says he was also surprised by the percentage of trials that the vendors set up themselves -- perhaps as many as half. Twenty years after the industry started, Shiple says, most vendors still start up clinical trials using software that sponsors of clinical trials would not rather use themselves.

Still, Shiple does not have much sympathy for those who express reservations about the software in the community of often-dubious trial sponsors. "Whenever I tried to pinpoint the objections, the objections were not terribly compelling," Shiple says. "I never found any of the problems they talked about as being intractable."





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