Dfdiscover software license agreement

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 an other than full and open competition basis with DF/Net Research, Inc. for a DFdiscover Software License Agreement.

The Office of Cyber Infrastructure and Computational Biology (OCICB) within the National Institutes of Allergy and Infectious Diseases (NIAID) provides leadership and direction on effective strategies, policies, and standards for technology services, support for biomedical research programs, information technology resources, and customer support.  This includes ensuring information technology infrastructure, tools, and applications fully and comprehensively support the NIAID mission. The Clinical Informatics Branch within the OCICB provides specialized support to facilitate the integration of IT and clinical expertise to support NIAID’s research mission. The branch specializes in leveraging expertise to manage the implementation and configuration of industry standard research management tools.  In addition, the International Biomedical Research Support Program within the branch focuses on providing information technology and communication systems support for biomedical research at various national and international medical research facilities. DFdiscover is a Clinical Data Management System that is used by OCICB and NIH lab partners to support clinical trials and studies globally for International collaborative research protocols. 

The Office of Cyber Infrastructure and Computational Biology (OCICB), International Biomedical Research Support Program (IBRSP) within the Clinical Informatics Branch (CIB) is requesting to renew and decrease the DFdiscover software license agreements starting May 1, 2025. DFdiscover is an agile clinical data management solution that streamlines data collection from every source and brings flexibility, quality, and speed to the daily work of collecting, verifying, and analyzing clinical data. This renewal includes 3 different license agreements as well as a Large Study Numbers extension - Applicable for all servers with DF2018 or newer which also extends the limit on number of studies per server from 250 to 999. DFdiscover (formerly Datafax) is a Clinical Data Management System that is currently used by OCICB and NIH lab partners to support more than 130 clinical trials and studies globally for International collaborative research protocols in the following countries, Mali, Uganda, Cameroon, Thailand, Cambodia, India, South Africa and in the United States. Currently, the DFdiscover server supports a user group with about 900 active users who have been trained and work within the system. DF/Net is the vendor and sole seller of the product, which is compliant with the FDA regulations, 21CFR part 11, and is used as an industry standard worldwide by pharmaceutical companies. Various NIAID international collaborative research protocols are conducted in remote locations and some of these clinical sites do not have reliable internet access and therefore need a system that can be used with older technology such as fax machines for submitting paper Clinical Report Forms (CRFs) into a Clinical Data Management System database but also has the flexibility to use Electronic Data Capture and mobile data capture. The Period of Performance date for the purchase is May 1, 2025, through April 30, 2026.

Capabilities statements must address the capability of providing a priority response equal to a direct contract/service agreement with the manufacturer.

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 capabilities statement that will be considered. The documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov, (subject line to reference NOI-NIAID-25-2254452 by 12:00 pm eastern standard time April 7, 2025. All vendors must register in the eSASS system to submit a capabilities statement. Instructions on how to register / submit quotes are included on the website. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit a capabilities statement that will be considered by this Agency.