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Clinical Trial Software

Fri, 02/04/2011 - 7:23am

OpenClinica, the world’s most popular open source clinical trials software for web-based electronic data capture (EDC) and clinical data management (CDM), has released a Beta version of OpenClinica 3.1. The release includes a completely rewritten version of Extract Data based around a plug-in architecture that increases flexibility and functionality.

“We’ve learned that user requirements for organizing, formatting, and presenting data are tremendously diverse and often conflicting, depending on the user, the intended purpose, the study and the organization,” said OpenClinica and Akaza Research Chief Executive Officer Cal Collins. “Our old Extract Data architecture made it difficult to add new output formats or tweak the ones already there. The new functionality provides a highly extensible, easily configurable means to get data formats that meet a user’s precise requirements.”

Nearly 12,000 users and developers in North America, South America, Europe, Asia, Africa and Australia comprise the worldwide OpenClinica community. A growing number of regulatory submissions have followed clinical trials using OpenClinica software.

According to Collins, OpenClinica started out with a desire to simplify the native output of the OpenClinica Extract Data java application, in a way that increased quality, stability, completeness, and performance. From now on, the OpenClinica core application will only produce CDISC ODM (version 1.3, with OpenClinica Extensions) as the natively supported format with output to other formats via XML Stylesheet Transformations (XSLT) of the native CDISC ODM .

“With only one native format, we’re better able to test, document, and guarantee the output. All other output formats generated are transformations from this native ODM 1.3 w/extensions format. We made sure we can export all possible data related to a study and its clinical data in this format, and users can use the pre-built transformations or create their own to get to their preferred formats. In 3.1, the export also includes all audit trail, discrepancy, and electronic signature information,” said Collins who expects OpenClinica 3.1 to be production ready this spring.

Because of its open source licensing model, OpenClinica stands alone as the most flexible, cost effective solution for EDC and CDM. The commercial version, OpenClinica Enterprise Edition, offers additional formats and features for large scale data capture and management along with comprehensive maintenance and support.

OpenClinica

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