OpenClinica Community Surpasses 10,000 Members

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Open Source Makes Significant Headway into the Realm of Clinical Trials Software

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OpenClinica’s professional open source model is ideal for the clinical trials industry

The growing community around the OpenClinica clinical trials software has surpassed 10,000 individual members, according to Akaza Research, the company that develops and maintains OpenClinica. This milestone represents a 3-fold increase in size over the past two years and helps to cement open source as a central part of the clinical trials software landscape.

Open source is both a type of software license and a software development model. It is characterized by transparency during development cycles and access to the end product's source code. The OpenClinica software, which offers electronic data capture (EDC) and clinical trial data management capabilities, has proven attractive to biopharmaceutical and medical device companies, CROs, and academic centers worldwide.

Akaza Research practices a professional open source approach offering a free Community Edition and commercial-grade, fully supported Enterprise Edition of OpenClinica.

“OpenClinica’s professional open source model is ideal for the clinical trials industry,” said Benjamin Baumann, Co-Founder and Director of Business Development at Akaza Research. “It reduces the rigidity inherent in proprietary EDC offerings in several important ways and is unparalleled in its ability to be customized, adapted, and easily deployed for diverse types of clinical studies. Trial sponsors, CROs, and academic centers using the commercially supported OpenClinica Enterprise Edition aren’t burdened with per-study fees, and maintain more direct control over their study design. In many cases these are significant barriers to efficient adoption of EDC.”

Large and active open source communities also help produce higher quality, more stable software systems. “OpenClinica’s vibrant, worldwide community adds significant value to OpenClinica adopters,” said Paul Galvin, OpenClinica Project Manager. “The transparent, participatory development model used to produce OpenClinica releases helps ensure that the product is well aligned with users’ real-world needs. In addition, it enables any issues with the software to be quickly identified and resolved. In the OpenClinica Issue Tracker, email forums, and other repositories of community knowledge you get the good with the bad—it’s completely unadulterated, unbiased information.”

The OpenClinica community members register at http://www.OpenClinica.org and gain free access to the OpenClinica software downloads, Issue Tracker, email forums, and the OpenClinica Case Report Form (CRF) Library. The community comprises individuals from over 70 countries on six continents.

About OpenClinica®

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 21 CFR Part 11, and other regulatory guidelines and is designed as a lightweight, standards-based, extensible, and modular platform. OpenClinica’s open source pricing model facilities a dramatically lower cost of use and ownership than proprietary, closed EDC and data management systems. All versions of OpenClinica are available for free download from http://www.openclinica.org.

About Akaza Research®

Akaza Research, the leading provider of open source clinical trial software, is headquartered in Waltham, Massachusetts. In collaboration with the 10,000 member OpenClinica open source community, Akaza has developed and commercialized OpenClinica under a professional open source model. Akaza brings Open Source Software (OSS) into the mainstream of the clinical research enterprise by making a robust, flexible, standards-based system accessible for all types of clinical research. Akaza Research provides OpenClinica Enterprise, a fully supported version of the OpenClinica platform with comprehensive support including installation, training, validation, upgrades, help desk support, customization, systems integration, and more. OpenClinica see http://www.akazaresearch.com.

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Benjamin Baumann

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