For a large fraction of the clinical trial community, clinical data standards are like 1,200-page Russian novels. People claim to read them but seldom do.

For electronic data capture (EDC) supplier Nextrials, however, standards are competitive weapons to showcase its strengths. This does not mean that Nextrials is brandishing anything. The firm is too nice. And standards are freely available to everyone. But the sword is there and being sharpened.

Nextrials recently turned 10 years old. The company has long been able to randomize patients and manage drug supplies from within its EDC system. Even some of Nextrials’ large rivals have no public road map to offer a similar set of features.

Beyond EDC

Now the firm is exploring a new frontier: connections to hospital and physician systems. The jargon is electronic health records (EHR). Co-founder and CEO Jim Rogers just got back from a trade show where he connected his system to half a dozen different EHR systems. He’s about to attend another similar event. Here’s a news release about the company’s work on the American National Standards Institute program to unite data from the general health care world and industry-sponsored research.

Back in the San Francisco area, where it’s based, Nextrials has dedicated a few programmers to helping the Clinical Data Interchange Standards Consortium (CDISC) refine its clunkily named “retrieve form for data capture (RFD)” specification. “We’re forward-looking,” says Rogers. “The technology is a lot further along than I thought it was. The standard works. Data exchange is possible today.”

The theoretical appeal of uniting EDC and EHR has been apparent on satellite images for years, he says. Now it’s time to inspect the terrain on foot. Real projects will help the industry understand the nitty-gritty details of what’s needed. “You need someone to go out there and cut back the jungle with a machete,” he says. That will give the industry and federal observers something concrete to examine and improve upon.

Partner Search

Rogers is in conversation with a huge EHR provider, Cerner, to do just that. And Nextrials is currently helping on a retrospective trial with five sites using the EHR of Carrolton, Georgia’s Greenway Medical Technologies.

Some of that data will be populated automatically. Some will be entered in the system manually; it’s not simply a data-mining project. Linkages to EHR systems are feasible today from a technical and regulatory perspective, Rogers says. The mechanics of cleaning EHR data and patient enrollment are being worked out.

The sole remaining issue, he believes, is the business rationale for EDC-EHR connections. And that’s where the game gets interesting. It’s not EDC suppliers that could be cut out of the loop. Rather it’s the contract research organization (CRO) industry, assuming sponsors can find sites and investigators using EHRs.

Rogers is using the company’s standards prowess to begin creating his own networks of investigator sites. He is also talking to sponsors about trial-feasibility assessments that combine EDC, EHR, and dozens or hundreds of sites using the same technology.

The vision is still taking shape. But Nextrials might be able to tell a sponsor, We have 2,000 sites that each have more than a dozen patients who match the inclusion/exclusion criteria for your project. And a sponsor might reply,  Fine, let’s start contracting with the top 100 sites.

Network Effects

In time, Rogers speculates, EHR-savvy EDC firms such as his, Outcome and the Phoenix Data Systems division of Bio-Imaging Technologies could morph into technology-oriented CROs.

Nextrials hopes to establish a large-scale pharmacovigilance network in which a huge pharmaceutical firm may participate. The idea is to lower the threshold of work required to submit a spontaneous adverse event form. Physicians or nurses could zap the data from the EHR they use every day, not fumble through a paper form or medieval federal website.

If widely deployed, such systems could improve on the estimated 10 percent of spontaneous adverse events that are currently reported. Such systems might reassure FDA and other regulatory agencies with active, real-time surveillance on a particular therapy or drug-event combination. That could boost public health and societal confidence in the industry. It could also mean that some additional trials won’t have to be run. Says Rogers: “Of all the things that we are doing, that’s the one that has me the most excited.”

New Hires

He is doing a few other things. Two key executives (Robert Lyons and Anthony Costello) left during 2008. By the autumn of last year, Rogers had replaced them. Robert Barr is Nextrials’ new chief technology officer. He came from Parexel, where he served as VP of software engineering, and before that at DataLabs, a California-based EDC firm. Barr is a soft-spoken, low-key fellow with no inclination to make outlandish promises. “Technology needs to be something that just works,” he says.

Barr believes that the industry’s technology is now mature: “I don’t think the underlying technology is going to change in any way. Now it is a matter of providing the quality of the service along with the product.“

Too Much?

Some people in the industry, he says, become enthralled by the ability to use technology to bolt on all manner of extraneous functionality. At times, Barr suggests, the industry may over-complicate a trial, adding bells and whistles to an EDC system that trigger unintended complications and problems down the road. “In the software, they say ‘I want it all,’” Barr notes. “On paper, they would never have gone there.”

Nextrials also recruited a new VP of global sales and marketing, Michelle Dockhorn. She’s worked at several sponsors, some of them large, and at PRA International, a CRO. Dockhorn believes that the CRO industry is one of the most discerning purchasers of any service or technology. “The CRO sale is the toughest,” she says. “If you can sell in that industry, you can sell in any industry.”

Nextrials, Dockhorn vows, will be hiring a few new sales people, all with operational backgrounds in the industry. She wants folks who know clinical trials and have lived the details. She is not simply seeking traditional hard-charging sales reps who could thrive in any industry.

Stepping Up

Rogers, meanwhile, doesn’t sound content to head just one of a dozen or so successful firms in the shadow of two EDC leaders. Instead, he’s aiming for the extremely contested #3 spot in the EDC space after Phase Forward and Medidata. He says those firms are now interested in preserving the costs and complexity of EDC, not in innovation or linkages to EHR systems that would be good for the industry. Says Rogers: “We would like to present [sponsors] with another choice. We would like to present ourselves as a smart EDC company that is more in tune with what the end users need—end users being sites and project managers.”

Rogers sounds mystified about why the industry would use a separate interactive voice response system (IVRS) if it could have one completely internal to the EDC system. “If you can randomize through the EDC system, which ours can, you don’t need IVRS,” he says. “We can do it cheaper than IVRS.”

At the same time, he acknowledges that serving smaller sponsors in the life sciences has its risks during an economic meltdown. A few customers have gone out of business. Revenue growth that might have been 30 percent in 2009 may just reach 20 percent, Rogers estimated, adding that he is aware that such numbers would be welcome in almost any industry in today’s economy.

Editor’s note: Here’s a ClinPage look at the firm’s trials running on iPhones.

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