Version 2.5 of OpenClinica Electronic Data Capture (EDC) Software Now Available

Akaza Research announces the availability of version 2.5 of OpenClinica, the popular open source clinical trials software. Full press release after the break.

(Cambridge, MA) September 29, 2008: Akaza Research announces the availability of OpenClinica 2.5, the popular open source clinical trials software. This release marks a major milestone for users of OpenClinica by adding a host of features, many of which are designed to better support regulated industry sponsored clinical trials.

OpenClinica 2.5 is freely available for download at http://www.openclinica.org.

Among the numerous improvements that comprise this release are:

  • New study monitoring and query management tools and reports
  • Import of data from external sources
  • Enhanced eCRF features, including scoring, multivariate edit checks, and rules
  • User roles for monitors and data managers
  • Electronic signature capabilities
  • Improved auditing and logging capabilities
  • Simpler CRF upload

In addition, this release provides a number of architectural enhancements:

  • Faster performance and improved scalability
  • Out-of-the box support for the Oracle database
  • Translation into 3 new languages: French, Italian, and Portuguese

“Many thanks to our partners in the OpenClinica community who have contributed to this substantial release,” said Paul Galvin, who manages OpenClinica development for Akaza Research. Galvin states that a growing proportion of OpenClinica’s improvements are coming from community contributions. “Our development team is spending more and more time collaborating with 3rd-party developers who provide code improvements. Just as valuable are the contributions from a core of dedicated end-users who provide ideas, feedback, and testing from the start of development through the final beta and release candidates.”

Akaza Research places code contributions it receives through rigorous vetting and validation procedures to ensure the open source software it distributes meet the quality and regulatory demands of the clinical trials industry. According to Akaza this version of OpenClinica has been more heavily tested than any before. Users of OpenClinica Enterprise, the commercial distribution of the OpenClinica source code, will have access to more than 230 test cases and the reports resulting from thousands of hours of testing.

The release of OpenClinica 2.5 also marks a proud day for Cal Collins, Akaza’s CEO. “There is tremendous excitement and anticipation among OpenClinica users for this release, and they will not be disappointed.” When asked what he feels is most significant about this release, Collins replied: “Version 2.5 is an excellent demonstration of how a motivated open source community can produce world-class enterprise software.”

Akaza Research will be conducting a webinar to present OpenClinica on October 7th, 2008. Registration for this event is available here:

Webinar @ 19:00 – 20:30 (GMT -4:00)
Webinar @ 9:30 – 11:00 (GMT – 4:00)

About OpenClinica�

OpenClinica is open source software for electronic data capture (EDC) and clinical data management. It facilitates protocol configuration, design of case report forms, clinical data capture, and study/data management. OpenClinica supports HIPAA and 21 CFR Part 11 regulations and is designed as a lightweight, standards-based, extensible, and modular platform. All versions of OpenClinica are available for download at http://www.OpenClinica.org.

About Akaza Research�

Akaza Research, the leading provider of open source clinical trial software, is headquartered in Cambridge, Massachusetts. Supported by the National Institutes of Health (NIH), Akaza has developed and commercialized OpenClinica, the preeminent open source clinical trial data capture and management software platform. Akaza brings Open Source Software (OSS) into the mainstream of the clinical research enterprise by making robust, flexible, standards-based systems accessible for all types of clinical research. Akaza Research provides OpenClinica support, training, and consulting services to its customers worldwide. See http://www.akazaresearch.com.

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