Dfdiscover software license renewal (ambis 2210649)

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 an other than full and open competition basis with DF/NET Research, Inc., 140 Lakeside Avenue, Suite 310, Seattle, WA 98122-6538, to procure a DFDiscover software license renewal.

This is a purchase for renewal of a DFDiscover software license for NIAID in the Office of Cyber Infrastructure and Computational Biology (OCICB), International Biomedical Research Support Program (IBRSP), within the Clinical Informatics Branch (CIB). 

This requirement is for the purchase of a DFDiscover software license. 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. DFdiscover is the only platform for clinical data management that provides the capability to have edit check programming for case report forms for clinical trials in the desktop client, paper forms, the world wide web client, and the tablet or smartphone application (both on and offline). Case Report Forms can be programmed into the system and then used for clinical trials with any of those forms of data entry. This data collection flexibility is critical for the remote villages in West Africa, East Africa, Southeast and South Asia because of the potential for loss of internet and need to use paper and in other cases the direct entry of clinical care data using the full client. Validating a computer system for use in clinical trials by an organization like OCICB is a lengthy and expensive process.  It also includes not only the system that meets the FDA regulatory requirements but also the documented operations and guidelines the organization implements to comply.  If we use a product that does not meet FDA compliance and regulations the NIAID vaccine development would potentially fail an audit by the FDA after a vaccine has been developed and submitted for authorization to the FDA by the NIAID Division of Intramural Research or Vaccine Research Center.

Description of the supplies/services to be purchased:

1. Production Server ai-datafaxprd3 with 36seats: 15 concurrent user seats, Primary server,15seats + 6 seats, DFhostid: JY6W-NRRS-E3YA-K9W8-JG9X10, DFws Application Program Interface (API)      
2. Development Server ai-datafax-dev3 with 2 seats: Secondary server, DFhostid: 8VA2-SBQY-6YLB-FBKZ-25GG, DFws Application Program Interface (API)
3. QA Server ai-datafax-qa3 with 2 seats: Secondary server @ $24,000 + 2 seats, DFhostid: 3HAM-TKPE-BLS9-CL7G-MFES, Includes DFws Application Program Interface (API)                 
4. Production Server qas-cl-dfdis-01.int.ibrsp with 28seats: 15 concurrent user seats, Primary server, 13 seats, DFhostid: JY6W-NRRS-E3YA-K9W8-JG9X, DFws Application Program Interface (API)                  
5. Development Server dub-cl-dfax-99.int.ibrsp.org with 2 seats: Secondary server, DFhostid:TP4J-TRP6-W6K9-XTXM-5T7Q, DFws Application Program Interface (API)                             
6. Large Study Numbers extension: Applicable for all servers with version DF2018 or newer, Extends the limit on number of studies per server from 250 to 999

J&A:  DFDiscover software license and all its component parts are the exclusive property of DF/Net Research, Inc. The licenses are proprietary software which can only be obtained from the manufacturer. DF/Net Research Inc. does not have any resellers/distributorships or service providers for their software.

Period of Performance(s) are as follows:

• May 1, 2024 to April 30, 2025

Service shall be performed at the following locations: NIH/NIAID/OCICB/IBRSP/CIB, 5601 Fishers Lane, Rockville, MD 20852.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (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 SOLICITATION FOR COMPETITIVE QUOTATIONS.  All responsible sources that could provide the required services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-24-2210649 to Rita Davis at rita.davis@nih.gov, by 11:00am eastern standard time Tuesday, March 5, 2024.  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.