OpenClinica Eyes Growth for 2011

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After coming off a year of rapid growth, the open source clinical trials software project expects to continue its momentum through 2011.

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A key component to OpenClinica’s growth is the increasing proportion of users representing pharmaceutical, biotech, device, and other companies.

Coming off a year in which it saw tremendous growth in the number of its users and clinical trial subjects, OpenClinica is anticipating continued growth in 2011, according to OpenClinica and Akaza Research Chief Executive Officer Cal Collins.

OpenClinica is the world’s most popular open source clinical trials software used for web-based electronic data capture (EDC) and clinical data management (CDM). Nearly 12,000 users and developers comprise the worldwide OpenClinica community.

“The open source model ensures participation by our ever-changing community of researchers and subjects,” said Collins. “In this day and age when people routinely gather online through sites like Facebook we have demonstrated that an open community can coalesce around electronic data capture and clinical data management and engage at a remarkable level. We believe this helps make OpenClinica more useful to more people.”

OpenClinica’s community spans geographic boundaries. Roughly 33 percent of OpenClinica users are located in North America; 30 percent in Europe; 14 percent in Asia; 9 percent in Africa; 7 percent in South America; and 7 percent in Australia.

In addition to OpenClinica’s open source model, industry is also attracted to the Enterprise Edition of the software which is commercially supported by Akaza Research. With its two-pronged approach to EDC and CDM, OpenClinica provides enhanced freedom and flexibility at a dramatically lower cost of ownership when compared with alternative proprietary technologies.

According to Collins, the composition of the OpenClinica community is changing over time, with an increasing number of OpenClinica users representing commercial clinical trials. Currently, 55 percent of the OpenClinica community members identify themselves as working in industry, with the remainder in academic or government settings.

“A key component to OpenClinica’s growth is the increasing proportion of users representing pharmaceutical, biotech, device, and other companies. In 2010, we saw a 975 percent increase in OpenClinica-powered trials used in regulatory submissions and in 2011 we expect to see significant continued growth in this area,” said Collins.

OpenClinica’s growth underscores the ten-fold increase in regulatory submissions which have followed clinical trials using the software Collins says.

About OpenClinica®

OpenClinica facilitates study protocol configuration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulatory guidelines and is designed as a standards-based, extensible, and modular platform. For more information – including product downloads – visit or follow @OpenClinica on Twitter.

About Akaza Research®

Akaza Research is the provider of the leading open source clinical trial software, OpenClinica. Trusted by hundreds of biopharmaceutical companies, contract research organizations, academic, and government organizations worldwide, Akaza’s professional open source model brings Open Source Software (OSS) into the mainstream of today’s clinical research enterprise. The company provides commercial support to its OpenClinica customers across six continents servicing clinical studies of all types and sizes. For more information, visit

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