Tool for Pharmacovigilance: for Infectious Disease, Combat Casuality Care and Biological Warfare and Chemical Defense Medications and Vaccines

Brief Description of Problem: Pharmacovigilance is a key area required for effective Force Health Protection. While good efforts have been made to address this problem, the traditional systems approaches used do not address underlying challenges such as data quality, unavailability and non-integration, and the expensive person-driven approaches to data mapping and integration inherent in traditional systems integration solutions. Innovations: FTI has successfully demonstrated that grid computing systems can be developed rapidly and fairly inexpensively, given the right toolset, experience, and "best practices". FTI's approach is innovative in that it: applies grid computing to the new application area of pharmacovigilance; employs an innovative open source software business model; and builds upon FTI's standards-based software development "best practices." Project Objectives: FTI's objective is to build a proof-of-concept prototype Advanced Pharmacovigilance Tool (APT) to address DoD's need for a "better, faster, cheaper" pharmacovigilance tool that is more robust, scalable, easier-to-use, more cost-effective, and contains data federation, warehouse, analysis and visualization capabilities. FTI will then refine this product for targeted marketing to government and commercial sectors. Technical Approach: FTI's working prototype will consist of the following components, built on open source/open architecture software: the Data Federation Module, the Data Warehouse Module, and the Data Analysis and Visualization Module. This product will be built on the foundation of the National Cancer Institute's Cancer Bioinformatics Grid (CaBIG) software product, designed to integrate data from multiple clinical trials, augmented by FTI's own grid computing software. FTI will validate prototype performance in a "real world" DoD clinical trials environment.