OpenClinica, the open source clinical trials software has seen a surge in usage over the past year, according to survey data released today by Akaza Research.
“Our recent survey of the OpenClinica community showed strong expansion in all key measurements of system usage,” said Cal Collins, Chief Executive Officer at Akaza. “In the past year we have seen doubling in the number of OpenClinica users and subjects, and a nearly 10-fold increase in regulatory submissions.”
The company reports that nearly 168,989 subjects have been involved in OpenClinica-powered clinical trials, a 224 percent increase from the prior year. In tandem, the company identified a 246 percent increase in the number of OpenClinica software users. The figure measures users working at the sponsor or CRO level and does not include users at clinical trial sites.
“Since these figures are based on a voluntary survey of the OpenClinica community, they are likely underestimates,” said Collins. “While it can be difficult to precisely measure the usage of freely distributed open source software, they provide a clear indication of the growth in OpenClinica adoption around the world,” he added.
The Professional Open Source Model
OpenClinica stands in stark contrast against the landscape of other EDC products that are provided under a closed source license. Akaza Research’s “professional open source” business model makes OpenClinica available in two editions. The OpenClinica Community Edition is freely available to use and modify, and may be downloaded form www.openclinica.org. The OpenClinica Enterprise Edition is a certified build of the open source technology commercially supported by Akaza Research. In many respects, the company’s business model is similar to that of RedHat (Linux), MySQL (database software), and other open source companies.
The OpenClinica rapidly growing open source community currently comprises over 10,500 users and developers, many of whom help review and adapt the open source software. 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. OpenClinica community members drive much of the product’s evolution, and in recent years have helped to usher the technology into a wide variety of clinical trial settings.
Worldwide Acceptance in Regulated Trials
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 identifies themselves as working in industry, with the remainder in academic or government settings.
According to Collins, “the robust overall growth is highlighted by an increasing proportion of OpenClinica users representing pharmaceutical, biotech, device, and other companies. We saw a 975 percent increase in OpenClinica-powered trials used in regulatory submissions in the past year, and in the next 12 months OpenClinica adopters expect to increase this number by another 200 percent. This is consistent with our OpenClinica Enterprise Edition customer growth, where a majority of new customers are from industry.”
OpenClinica is open source, web-based clinical trials software for electronic data capture (EDC) and clinical data management (CDM). 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. The OpenClinica Community (free) and Enterprise (commercial) Editions provide a dramatically lower cost of ownership when compared with alternative proprietary technologies. For more information (including product downloads) visit http://www.openclinica.org 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 http://www.akazaresearch.com.