DataFax Clinical Trial Management System Software

NOI-RML-1961404

NAICS - 511210

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), intends to negotiate on another than full and open competition basis with DF/NET Research Inc. to procure software maintenance for existing DataFax Clinical Trial Management System Software; period of performance 05/01/2019-04/30/2020.

DataFax is a Clinical Trial Management System (CTMS) and is needed to support various NIAID international collaborative research protocols. NIAID supports more than 90 clinical trials and studies for the International collaborative research protocols in Mali, Uganda, Cameroon, Thailand, Cambodia, China, India, South Africa and USA. DataFax software supports a need for a system that can be used with older technology such as fax machines for submitting paper Clinical Report Forms (CRFs) into a CTMS database but also has the flexibility to use Electronic Data Capture. In addition, the system is compliant with the FDA regulations, 21CFR part 11.

This software requirement is made up of 3 different license agreements which include the following: 31 seats on the Production server ai-datafaxprd3, 2 license seats on the Development Server ai-datafax-dev3, and 2 license seats on the QA Server ai-datafax-qa3.

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-RML-1961404) to Jesse Weidow at jesse.weidow@nih.gov, by 3:00 pm eastern standard time Tuesday, April 18, 2019 All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

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