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Akaza Research partners to develop Adverse Event Reporting System for caBIG

(CAMBRIDGE, MA) May 11, 2007 — SemanticBits, LLC, and Akaza Research announced today renewal of their partnership with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University to develop open source software for cancer clinical trials. The group has been awarded the second phase of a contract from the National Cancer Institute to develop the Cancer Adverse Event Reporting System (caAERS) platform for the National Cancer Institute’s Cancer Bioinformatics Grid (caBIG™) initiative.

caAERS will be a nationally scalable, highly configurable adverse event (AE) reporting system for use by organizations running NCI-sponsored clinical trials. The caAERS system will be an open source, grid-enabled, caBIG™-compatible application that will be fully interoperable with other caBIG-compliant systems.

The caBIG™ initiative makes critical tools and data accessible to cancer researchers worldwide to speed the development of innovative approaches for cancer prevention and treatment. The cutting-edge infrastructure developed by caBIG™ has broad utility for other disease areas as well.

This second phase of the caAERS project will build on earlier work done by the group since December, and will be completed in August 2007.

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 SemanticBits, LLC

SemanticBits, based in Reston VA, is a computer software development company founded in 2001. SemanticBits specializes in the design and development of software systems for the health and life sciences industry, which includes creating effective, interoperable and reusable informatics solutions to solve complex issues in the biomedical research domain. Apart from caAERS, SemanticBits is currently engaged in several other high profile NCI sponsored projects, such as Cancer Translational Research Informatics Platform (caTRIP), Cancer Central Clinical Participant Registry (C3PR), Clinical Trials Management Systems Interoperability (CTMSi) and caGrid. SemanticBits is working closely with several prominent cancer centers, such as Robert H. Lurie Cancer Center of Northwestern University, Duke University Comprehensive Cancer Center, Mayo Clinic Comprehensive Cancer Center and Wake Forest University Comprehensive Cancer Center.

About OpenClinica

OpenClinica™ 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 v2.0 was released in November 2006 under the GNU Lesser General Public License (LGPL). See www.OpenClinica.org.

About the Robert H. Lurie Comprehensive Cancer Center of Northwestern University

First established at Northwestern University in 1974, and was rededicated as the Robert H. Lurie Cancer Center in 1989 based on the generous endowment of Ann and Robert H. Lurie. In 1998, the National Cancer Institute (NCI) awarded the Cancer Center the highly competitive "comprehensive" designation - reflecting the Cancer Center's dedication to the highest standards of cancer research, patient care, prevention and education.

Today, the Robert H. Lurie Comprehensive Cancer Center of Northwestern University has more than 300 faculty and opens more than 150 clinical trials per year, with basic and clinical research programs in cancer. See www.cancer.northwestern.edu for open trials and research programs.

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