No one ever accused electronic data capture (EDC) systems of glamour. They all have a certain tabular sameness. EDC may be a newly welcome, even essential technology in the pharmaceutical industry. But beautiful?

Yes, actually. At least from Nextrials.

Founded in 1999, based in the San Francisco area, the company recently reported a new medical device customer, Ekos, and a sixty percent jump in six-month revenues. (The privately held Nextrials doesn’t release dollar amounts or audited financial statements.)

Years before competitors, Nextrials added features that only a few EDC rivals have duplicated. To take one example, Nextrials’ EDC application, Prism, has long had the out-of-the box ability to manage drug supplies. Nor is there a need for a separate system for patient randomization.

Early support of CDISC data standards also gave Nextrials an edge in handling central lab data. The company can automatically generate queries on out-of-range values from any central lab.

Device Interface

Nextrials has more interest than most EDC companies in connecting peripheral devices to its system. At the recent Society for Clinical Data Management conference, Nextrials exhibited a simple way to tightly link a novel, non-invasive breast scan from Z-Tech to the patient’s demographic data. The patient and the scan are automatically in the EDC database after that. The press release is here.

So if you want to know where the rest of the EDC industry is headed in 2010, you can check out what Nextrials is doing now. Which is why were intrigued to see Nextrials has launched four new mini-applications. Called Prism Tools, they are both a way to navigate through Prism and distinct, standalone applications in their own right.

Prism Tools depend upon web-friendly components like Java, Ajax and Adobe Flex, the successor to Flash (which Adobe purchased). These are what websites outside pharma use to to deliver interactivity.

Nextrials is not the only EDC company using such stuff. But the company has made very skillful use of it. We think the new mini-applications from Nextrials could take a significant amount of the drudgery out of working with clinical data.

Patient Recruitment Tool

One mini-application is called NextPatient. It can help with patient and site recruitment. The program needs access to data from an electronic health record (EHR) system. NextPatient could be a fast and easy way to identify sites, physicians or hospitals for industry research. As Costello put the program through its paces, it was a surprisingly fluid combination of what clinical trial professionals need—with the information already present in hospital systems.

In NextPatient, the user can set trial inclusion and exclusion criteria, using numerical values or checkboxes, and voila! Lists of patients, investigators or centers appear. Adjusting the criteria instantly refreshes the list. It is extremely intuitive. We can imagine the program being loved to death by ordinary nurses and physicians with minimal tolerance for clunky software.

image

Patient Locator: NextPatient recruitment tool from Nextrials.

Costello didn’t design the tool to be glitzy. He’s been watching the EHR industry explore the clinical trial space, and vice versa. Nextrials recognizes that there is a practical side to working with hospital or physician data. “If you can get the patient recruitment upstream, it’s much easier to worry about auto-populating the clinical data downstream,” he says.

Branching Out

Then there’s a hyperbolic tree, which is built into a Prism Tool called NextView. In the world of data visualization, hyperbolic trees can be used to both display and investigate mammoth hierarchical datasets like the locations of stars or the U.S. Library of Congress.

Hyperbolic trees were inspired by the artist M.C. Escher but patented by Xerox. There is a Facebook hyperbolic tree program to tie your college pals together in a graphical pattern.

The static Nextrials tree shown here doesn’t do it justice. You can click on a patient (in an orange rectangle) and watch the branches explode or contract with data about the patient. It beats clicking through an endless series of boxes and pull-down menus. “You’re looking at an entire EDC system here,” says Costello.

image

Hyperbolic Tree: The NextView application from Nextrials

The program could easily show all the adverse events or any other type of data. Says Costello: “It’s a much better way to drill around. If you saw something interesting on a physical exam, it would be easy to drill down on that physical exam for all patients.” He says the hyperbolic tree could be easily adapted for FDA reviewers to inspect regulatory applications; or used in post-approval registries so that investigators could visualize their own data.

Standards Champions

Nextrials’ support of CDISC and HL7 data standards is what makes the new Prism Tools work. Says Costello: “We’re building a toolkit that sits on the CDISC operational data model (ODM) but leverages the newest, most cutting edge web technologies that are out there.”

Rival EDC vendors with older or more proprietary architectures will no doubt point out that there is a certain comfort or familiarity with the grids and boxes of most EDC systems. That familiarity is a good thing for site personnel who must use multiple EDC systems.

But it’s worth noting that when Apple developed the scroll wheel on the iPod, the user interface of every other portable music player suddenly looked dreary. If any major EDC rivals take up the hyperbolic tree, Nextrials can add it to the list of features they pioneered.

‘The Rest of The Puzzle’

“This is a whole new product line,” Costello says of the mini application suite. “It obviously works nicely with the EDC system. You don’t have to do EDC. You don’t have to use us as the EDC provider to get the value out of the recruitment tool.” In discussing a company like Octagon Research, which acquired an EDC platform to complement its electronic submission software, Costello sees the clinical trial technology landscape broadening over time. “There are interesting plays being made for people to cover a larger piece of the clinical trial process,” he says.

Costello thinks designing EDC systems could become a bit easier in some future era of widely adopted CDISC standards. “All of this standards stuff is going to very quickly commoditize EDC,” he says. “The value proposition is what else are you doing? Any idiot can write a style sheet that makes a web page look like a case report form (CRF). It isn’t going to be about the CRFs any more than CRFs were about the printing companies that made them. It’s about the design of the rest of the puzzle.”

Growing Business

We also had a recent chance to chat with Jim Rogers, president and CEO of Nextrials. His Java, Flex and Ajax-based Prism Tools, he says, are paying dividends for the end user’s experience. How? Because of greater performance related to less information that has to be sent across the internet. “Instead of resting on our laurels, this is a revolutionary change,” says Rogers. “We’re still pushing the technology edge in the industry.”

Rogers acknowledges that technology is just the starting point. “It’s not just about the software,” he says. “It’s about the service and support. Who’s your project manager? How much does he or she know about clinical research?”

The Middle Tier

Rogers says business is good. Not long ago, a typical customer might use Nextrials for a 20-site Phase II study. Now it might sign up for a 250-site Phase III project. Rogers says maintaining service remains an issue for all EDC suppliers. “That’s an issue,” says Rogers. “It’s a big issue. Once you start with a client, it’s up to you to keep them.” Arqule recently signed up for its ninth trial. There are also two contract research organizations on the Nextrials customer list.

Mentioning the two largest names in the EDC landscape, Rogers says they have great products, and concedes he’s nowhere near their size. But some big competitors, he says, can’t always meet the lofty expectations of service in the industry. That’s also true of his peers in the EDC sector, he says. “We are reaching a maturity point where the middle tier is starting to shake out,” says Rogers. “Adoption is definitely accelerating. We’re seeing a lot more interest than we have in the past.”

d9A2t49mkex