Akaza Research has been awarded a Phase II SBIR grant from the National Institutes of Health for the OpenClinica open Source clinical trials platform. Read on for the full announcement.
(Cambridge, MA) July 23, 2007 � Akaza Research, LLC announced today that it has been awarded a two-year Phase II SBIR grant from the National Institutes of Health to continue development of the open source clinical trials data capture system, OpenClinica.
The objectives of the project include further development of the OpenClinica open source community, addition of new features, such as calendaring, coding, and adverse events to the core OpenClinica platform, and implementation of data exchange capabilities.
Akaza will work with the nearly 2,000 members of the OpenClinica open source community to create a community-based development, governance, and quality management model for ongoing open source software development that meets the rigid quality requirements of Good Clinical Practice Computer Systems Validation.
The OpenClinica team will utilize this innovative model to create flexible solutions that reduce data redundancy, aid cross-study data collection, and provide for distributed management of user permissions, privacy, and regulatory compliance. It will build off other open, standards-based technology platforms to support distributed services and data exchange with heterogeneous systems via a federated, standards-based, metadata-driven �data grid�.
The OpenClinica architecture will be harmonized with relevant clinical data standards and interoperability initiatives, such as CDISC, BRIDG, and caBIG, to tightly integrate a suite of modular open software components.
Akaza�s CEO and the grant�s principal investigator, Cal Collins, said of the effort, �There is a powerful potential for standards-based, open source software to positively transform the clinical research enterprise. Data sharing capabilities of this type are essential for translation of research into knowledge, products, and procedures to improve human health. We are excited about the opportunity to build on the success of OpenClinica to date as a leader in the field.�
Co-investigator Tom Hickerson added, �We believe that open collaboration, within the OpenClinica community as well as with other leading initiatives is key to facilitating the transition of paper-based business processes to electronic systems in the clinical research enterprise.�
penClinica is an open source, web-based electronic data capture for clinical research. 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. The current production release of OpenClinica is version 2.0.1. All versions of OpenClinica are available for download at www.OpenClinica.org.
About Akaza Research
Akaza Research, the 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.
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