36C10B18C2744-001.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Acquisition Operations Technology .Acquisition Center 23 Christopher Way Eatontown, New Jersey 07724

2. Description of Action: The proposed sole source action is for a firm-fixed price effort for the renewal of brand name Datalabs software licenses and associated software maintenance and supportwith Parexel lnternatiorn�I Corporation (henceforth referred to as Parexel) 195 West Street Waltham, Massachusetts

(MA), 02451-1111.

3. Description of Supplies or Services: The Department of Veterans Affairs, .Office of Research and Development (ORD), Massachusetts Veterans Epidemiology Research and Information Center {MAVERIC) requires support and maintenance of 200 existing Datalabs perpetual licenses and renewal of existing Datalabs term licenses with associated support and maintenance at 125 sites, in support of the Cooperative Studies Program (CSP) clinical trials. Datalabs is a software package that provides a web based data capture tool utilized for managing clinical trial studies and data within the CSP. The CSP presently owns 200 individual Datalabs licenses in support of CSP clinical trial 578 and 125 term site licenses in support of CSP Trials 590 and 595. In 2004, Datalabs software maintenance and support was procured per individual license on a perpetual basis.

Subsequent to 2015, Parexel evolved its licensing model and the newer licenses were term. In September 2015, VA procured 60 term licenses in support of CSP trial 594 and, in S.eptember 2016, VA procured 65 term licenses in support of CSP trial 590. The CSP is a VA-wide program that runs multiple, national clinical trials for the ORD and helps in the research of various healthcare issues that directly relate to Veterans. This program not only analyzes the medical aspects of the research but also the economic impact these possible clinical trials would have if implemented. Support consists of bug fixes, patching, security fixes, and 12X12X5 telephone support. The period of performance is July 1, 2018 through June 30, 2019 with one, 12-month option period.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements."

5. Rationale Supporting Use of Authority Cited Above: The proposed source is Parexel 195 West Street Waltham, MA, 02451-1111. Based on market research, as described in Section 8 of this document, the Government has determined that no competition is available for this action. The current CSP data infrastructure is based on existing Datalabs software and VA requires licenses and support compatible with the existing infrastructure protocols and functionality for continued operational availability. CPS has eight years of research data that can only be accessed using

P03 - Signed JA_Redacted