Akaza Research Announces a Road Map and Timetable For the Release Of OpenClinicaTM 2.0



Akaza Research is pleased to announce a roadmap and timetable for the next release of OpenClinica, the rapidly evolving Open Source clinical research software package. Many of the new features in OpenClinica are intended to help increase adoption and expand OpenClinica'ss capabilities. With this new release, OpenClinica will enhance efficiencies in data capture, study design and management, usability, and security.

The new features in OpenClinica 2.0 take into account improved services-based architecture and interoperability capabilities. These features are based on published standards for clinical research which facilitate interoperability, data sharing, and grid computing.

's8220;We believe that OpenClinica 2.0 represents a significant advancement in the state-of's8211;the-art for clinical trial software,'s8221; said Ben Baumann, V.P. of Marketing for Akaza Research, 's8220;Our roadmap demonstrates Akaza's8217;s continued commitment to OpenClinica, the premier Open Source clinical trials management system.'s8221;

OpenClinica 2.0 is scheduled to be released to beta testers in June 2006.

OpenClinica 2.0 features and highlights:

·    Enhanced Electronic Data Capture and Data Management
·    Source Data Verification: New capabilities for Coordinators and Monitors to conduct source data reviews and provide sign-off/check-off on CRFs and subject records.
·    Data output in SAS and CDISC XML format
·    Auto-generated Study Subject IDs that incorporate custom organizational and sourcing attributes
·    Support for publicly accessible controlled vocabularies
·    Expanded capabilities for maintaining contact information for study participants and personnel, and organizational info across study protocols and sites.
·    Printable versions of all pages and views, including output to PDF and Excel file formats
·    Improved Security and Administration
·    Improved security and role/privilege management, including improved LDAP integration support and JSR 168 Portal Integration
·    Improved audit logging, access, and reporting for study monitors
·    New System Configuration Properties and management interface
·    Trouble ticketing system that links each OpenClinica implementation with OpenClinica's8217;s Enterprise Service Infrastructure.
·    Architecture and Interoperability
·    Improved data persistence layer using Hibernate and/or iBATIS
caBIG Silver-level Compatibility (see https://cabig.nci.nih.gov/guidelines_documentation) to facilitate interoperability with other systems in the clinical research environment, particularly in cancer research
·    eDCI (Data Collection Instrument) CRF metamodel compatibility (see http://www.bridgproject.org/edci/) - Compatibility between the OpenClinica CRF metadata model and the eDCI metadata model, to support a platform-independent CRF definition and CRF exchange through HL7v3-compliant XML-based messaging.
·    ISO 11179-compliant metadata registry - architecture and data
definitions for all OpenClinica data elements, including CRF items.
·    UI Accessibility: Full compliance with Section 508 requirements for accessible software.

About Akaza Research
Akaza Research, a 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 collection and management software platform. Akaza brings Open Source Software solutions into the mainstream of the clinical research enterprise by making high quality, standards-based systems accessible for private and public research. Akaza Research provides support, training, and consulting services to its customers worldwide. See www.akazaresearch.com.

About OpenClinica's8482;
OpenClinica's8482; is an open source web-based software platform that enables sponsors and investigators to manage clinical research data in multi-site studies. It facilitates protocol configuration, design of case report forms, electronic data capture, and study/data management.

OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a strictly standards-based, extensible, and modular platform. OpenClinica v1.0 was released in October 2005 under the GNU Lesser General Public License (LGPL). See www.OpenClinica.org.





Akaza Research Announces a Road Map and Timetable For the Release Of OpenClinicaTM 2.0