At first glance, OpenClinica looks likes a very polished product.  Based on the demo application, the web pages are snappy, and the user-interface seems pretty clean and friendly.  Of course it was a demo study, so it’s not clear how the application will fair under the heavy load of a phase III or phase IV clinical trial.  This definitely seems like something worth investigating, and here’s some more details.

OpenClinica is a web-based EDC (electronic data capture) vendor.  EDC usually refers to electronic data capture solutions for clinical trials.  What makes OpenClinica unique is it’s open source!  Back in April 2007, the OpenClinica community had 1,300 members.  In April 2008, it had over 3,500!

On March 9th, 2005, Akaza Research released OpenClinica Beta Software and Portal.  Akaza Research is a Massachusetts-based biomedical informatics firm.  A little over 9 months later, on December 23, 2005, Akaza released OpenClinica 1.0.  On November 15, 2006, OpenClinica 2.0 was released.  Now, OpenClinica 2.5 is in beta and appears to be nearing release.

Their website indicates their features include protocol configuration, CRF design, data extraction, clinical data management, and support for HIPAA, 21 CRF Part 11 and GCP (all significant regulatory guidelines/requirements).

Enough with the feature list, let’s hear about the technology!  It seems they are about as open-source as it comes.  Developed using the J2EE framework, uses PostgreSQL 8.x (among many other databases supported), and it runs on Linux (as well Windows Server).  Although it was developed to run on Apache Tomcat 5.x, they say any Servlet/JSP container that implements the Servlet 2.x and JavaServer Pages 2.x specifications will do.

Definitely worth a look!