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Project One helps healthcare organizations reduce costs, streamline administrative processes, comply with regulatory requirements and overall improve the quality of care. For pharmaceutical and biotech firms, we support all aspects of the drug development cycle from discovery, clinical trials and regulatory approval to manufacturing and marketing.
Disease Management Systems – Data Modeling – provided data analysis, data architecture and data modeling using ERwin for a Disease Management System – consisting of patient, clinical, financial and administrative information. Integrated distributed data into an enterprise-wide DB2 database while maintaining HIPAA compliancy. Medical Research Lab – Web Development – assisted in the development of Medical Research Lab applications to support monoclonal antibodies research. Developed ASP.Net programs using VB.Net, C#, SQL Server to track research projects, resources, budgets, and reporting. Patient Accounting – Business Analysis – requirements gathering and data analysis to develop a series of customized reports and financial analysis to support a group of community health centers. Developed adhoc and standardized reports using Crystal Reports, SQL and SQL Server Reporting to meet the needs of medical directors, health center payers, funders, regulatory stakeholders and policymakers. Regulatory Reporting – Technical Writing – created procedural reports to support 21 CFR Part 11 FDA regulations. Worked with internal staff to review, update & approve validation documentation. Pharmacy Benefit Management – Q/A Testing – for a large PBM – pharmacy benefit management company, developed UAT plans for their Formulary applications. Created a regression testing process to assure future system changes met all quality control specifications prior to deployment. Biotech Research – Web Development – created .Net C# Java and Oracle PL/SQL applications to support the discovery and pre-clinical areas for this life sciences company. These applications tracked research lab projects for bioinformatics, cheminformatics, toxicology and other areas. |