Is giving away electronic data capture (EDC) a viable strategy? Yes.

Even as the top suppliers of EDC get even larger, some of the smaller providers are still prospering. A case in point is Akaza Research, which created the free OpenClinica solution and prospers by selling additional services and support.

This week, the company released a new test or beta version of its software. That version streamlines getting data out of the EDC system to facilitate analysis for operational and statistical purposes. You can read more about the software's ability to support custom data transformations here.

With 30 full-time employees, the company must be responsive to a thriving community of 11,000 folks who need no help in understanding the improbable idea of open source software for the pharmaceutical industry. "We see a tremendous increase in both understanding and acceptance of the open source model," says Cal Collins, Akaza's co-founder and CEO since its inception in 2006. "Our growth has been fantastic."

Expanding Base

The company has 56 clients paying for the corporate version of its software, and another 300 or so using the free version. In the 2010 annual survey of those users, Collins reports, the company recorded a 62 percent rise in the number of trials using the OpenClinica platform and a 950 percent spike in the number of trials that used the system in a regulatory submission. Without the raw numbers, of course, it's impossible to tell how broad the adoption of the system is.

But in brief, some sponsors and contract research organizations (CRO) appear to want to know what's under the hood of an EDC system—and even the ability to tinker with the engine. "We've developed a highly rigorous quality system that both follows the guidelines for computer system validation and provides the additional transparency that comes with open source, down to seeing the source code," Collins adds.

New Neighborhood

The volunteers in the OpenClinica community mean that public bits of code can be as thoroughly tested as anything in the commercial software industry. Just as some security-conscious companies have given up on Microsoft's Internet Explorer browser in favor of the open source Firefox alternative, OpenClinica is appealing to companies that want a less closed, proprietary solution.

Collins says one large sponsor is quietly using the system, but he can't divulge its name. The company has moved from its quintessential startup offices in Cambridge, Mass., to a larger space in nearby Waltham, where larger clinical technology rivals such as Parexel and Oracle reside.

Cost Advantage

Part of the appeal of open source is Akaza's pricing, which appears to be resonating with CROs in a tightening financial environment for research. "There is no trial or per case report form (CRF) or per patient license or any other license fee," Collins says. "A customer can scale up. We tend to come in at 25-40 percent of the cost of competing vendors. The more the CRO wants to do themselves as far as the trial build, the less they pay us."

In some cases, he says, CROs are testing the OpenClinica solution without any contact from Akaza. "Many CROs that have had their own in-house system for paper-based trials or EDC are starting to move away from those," Collins says. "They tend to find and evaluate OpenClinica on their own, and they're able to get a good idea of whether it's a good fit before we even talk to them."

The use of technology for clinical trials is lagging in academia. But Collins says there is activity there, too, with almost half of OpenClinica users working in government or universities. To the extent that new industry employees are recruited from those worlds, there could be more usage of his open system in the years to come.

Here's a previous article on the company from 2008.

d9A2t49mkex