Release of OpenClinica 2.0 – LGPL platform for clinical research

Akaza Research is pleased to announce the availability of OpenClinica 2.0, the open source clinical research software platform. 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 was initially released in October 2005 and is licensed under the GNU Lesser General Public License (LGPL). This new release includes enhancements in the areas of data capture, study design and management, usability, and security. OpenClinica is based on published standards for clinical research which facilitate interoperability and data sharing. For more, see www.OpenClinica.org.

OpenClinica(TM) Version 2.0 Now Available � Numerous New Features and Increased Interoperability

(CAMBRIDGE, MA) November 13, 2006 � Akaza Research is pleased to announce the availability of OpenClinica 2.0, the open source clinical research software platform. This new release includes enhancements in the areas of data capture, study design and management, usability, and security. OpenClinica is based on published standards for clinical research which facilitate interoperability, and data sharing.

“OpenClinica 2.0 represents a significant advancement in the state-of�the-art for clinical trial software,” said Cal Collins, CEO of Akaza Research, a major sponsor of OpenClinica. “It offers an unparalleled flexibility to operate in multiple IT environments and clinical settings, while meeting any budget size. As a result, we are seeing leading research institutions adopting OpenClinica at an increasing rate.”

Key features and highlights new in OpenClinica 2.0 include:

    • Enhanced Electronic Data Capture and data management workflows
    • Improved tools for subject tracking, workflow management, and study coordination
    • Data output in SAS and CDISC XML format
    • Auto-generated Study Subject IDs
    • Improved printing of CRFs
    • Improved security and role/privilege

management, including improved LDAP integration support

  • 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 Akaza’s OpenClinica Enterprise Service Infrastructure.

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

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 v1.0 was released in October 2005 under the GNU Lesser General Public License (LGPL).

For more, see www.OpenClinica.org.

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