RFI: U.S. Army Medical Research Institute of Infectious Diseases DoM Clinical Data Management Software (CDMS) and Support

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is conducting market research to obtain information regarding sustainment and maintenance services on a program that will capture the data needed to report to the Food and Drug Administration (FDA) on the closely monitored and scrutinized schedule for the nine different Investigational New Drugs (INDs) offered within the Division of Medicine (DoM) at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

Task #1 – Provide Clinical Data Management Software (CDMS). Provide Software that is able to achieve an Authority to Operate upon completion of the Department of Defense Information Assurance and Accreditation Process (DIACAP). (CLIN 0001)

Task #1.1. Provide software that is compatible with Army/Vendor supported core applications; to include Oracle Database, Oracle WebLogic, Oracle Java, Microsoft Windows, Microsoft Windows Server, and Internet Explorer…

Task #2 – Provide Clinical Data Management Software (CDMS). Provide Software that is able to meet Food and Drug Administration (FDA) requirements. (CLIN 0002)

Task #2.1. Provide remote or onsite technical support to ensure the proper installation of all major upgrades to Omnicomm software…

Task #3 – Ad Hoc Professional Services. Services included that are unplanned due to: 1) emerging requirements; 2) manpower shortage on the government’s part; 3) timeline compression due to national emergency.

Task #3.1. Configuration of clinical trials protocols…

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