Sole Source Justification and Approval_Redacted.pdf

Control Number: VA-20-00050415

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics (OPAL)

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 support with Parexel International Corporation (Parexel) 195 West Street Waltham, Massachusetts 02451-1111.

3. Description of Supplies or Services: The Department of Veterans Affairs (VA), Office of Research and Development (ORD), Massachusetts Veterans Epidemiology Research and Information Center requires the renewal of software maintenance and support for 200 existing Datalabs perpetual licenses and renewal of existing Datalabs term licenses with associated maintenance and support at 125 sites in support of the Cooperative Studies Program (CSP) clinical trials. 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. Datalabs is a software solution 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 perpetual licenses in support of CSP clinical trial 578-Prevention of Serious Adverse Events Following Angiography and 125 term site licenses in support of CSP trials 590-Lithium for Suicidal behavior (CSP trial 590) and 594-Comparative Effectiveness in Gout (CSP trial 594). In 2004, ORD procured the initial 200 Datalabs perpetual licenses with associated software maintenance and support.

Subsequent to 2015, Parexel evolved its licensing model from perpetual to term licenses. In September 2015, VA procured 60 term licenses in support of CSP trial 594 and, in September 2016, VA procured an additional 65 term licenses in support of CSP trial 590. Software maintenance and support consists of feature releases, bug fixes, patches, security fixes, and telephone support five days a week during regular business hours. The period of performance is 12 months from July 1, 2020 through June 30, 2021 with two 12-month option periods for continued license and software maintenance and support renewals.

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) 6.302-1 titled, "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, Massachusetts 02451-1111. Based on market research, as described in Section 8 of this document, the Government has determined that Parexel is the only source capable of providing the required software

MAVERIC Datalabs Licenses and Control Number: VA-20-00050415 Maintenance Support license renewals and associated maintenance and support; therefore, there is no competition anticipated for this acquisition. The current CSP data infrastructure is based on existing Datalabs software and VA requires software licenses and associated maintenance and support compatible with the existing infrastructure protocols and functionality for continued operational availability. CSP has been utilizing Datalabs software since 2004 as its data capture tool for managing multiple clinical trials and currently has eight (8) years of ongoing research data that can only be accessed using Datalabs licenses. Datalabs software is the only software that is compatible and interoperable with CSP’s existing data infrastructure, and renewal of the existing term licenses is required so that researchers can access existing data associated with ongoing clinical trials. Without renewal of the existing Datalabs term licenses, users would not be able to access the system thereby losing the ability to review, update, edit, and analyze over eight (8) years’ worth of critical clinical data for ongoing trials. In addition, the Government’s technical expert, the Chief of Database Development for MACERIC estimates that replacing the current Datalabs solution would take approximately 2 years to procure, implement, configure, test and validate, migrate existing data and train researchers at an approximate cost of over $1,000,000.00 in duplicative costs that would not be recovered through competition.

This estimate is based on an approximate acquisition timeframe of 6 months followed by an 18-month period to implement, configure, test and validate, migrate and train end-users.

Further, as this is proprietary software, no other vendor can provide the maintenance and support which includes: feature releases, bug fixes, patching, security fixes and telephone support. The required software maintenance and support provides application support in the event there is a problem with the system. Datalabs has and continues to resolve application issues that, if not resolved, would have a significant impact on the CSP's ability to continue to collect data including instances where the entire system has been unavailable. Without the required software maintenance and support, the CSP would experience extended downtimes and, in a worst scenario, the system would not be available at all to researchers. If researchers are not able to retrieve and analyze the data within the solution, it would negatively impact future clinical outcomes which could potentially improve the wellbeing for Veterans. Without the required maintenance, the Government would not have access to critical updates, releases and fixes resulting in potential severs security vulnerabilities and an inability to utilize the solution. For example, recently, Parexel provided a new release for the Datalabs software that resolved major internet security vulnerabilities. These vulnerabilities would have put VA at significant risk for the potential release of Veteran Personally Identifiable Information.

In addition, without these fixes, Infrastructure Operations would not issue an Authority to Operate for the Datalabs solution. This would have the potential to shut down the entire CSP program. Finally, Parexel owns all rights to the Datalabs software and does not allow resellers to provide the software or maintenance support services. As such, only Datalabs software and maintenance support can meet VA’s requirements, and Parexel is the sole provider of the required Datalabs software, maintenance, and support.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any

MAVERIC Datalabs Licenses and Control Number: VA-20-00050415 Maintenance Support additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. The proposed action will be synopsized on the Contract Opportunities page in accordance with FAR 5.201. Any proposals that are received shall be evaluated. Additionally, in accordance with FAR 6.305(a) this Justification for Other Than Full and Open Competition will be made publicly available on the Contract Opportunities page within 14 days after contract award.

7. Actions to Increase Competition: The Government is currently conducting market research to determine if new cloud-based, electronic data capture systems can be implemented at the CSP. The estimated timeframe to replace the system based on lifecycle is 2025. The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. The program office will continue to monitor the market for availability of other solutions that are compatible with VA’s infrastructure, and will continually conduct test and evaluation of those tools when feasible for consideration during the next competitive procurement and/or technology refresh.

8. Market Research: In October 2019, market research was performed by the Government's technical experts via web research. The market research confirmed that while web-based data capture software is available from other manufacturers such as Metadata, OpenClinica, and DataFax, none of them are compatible with CSP’s existing data infrastructure and would require a completely new implementation estimated to cost $1,000,000.00 and take approximately two years to complete. Additionally, the market research confirmed that only Parexel can provide the required software maintenance services due to the proprietary nature of the software. Furthermore, an email received May 7, 2020 from Parexel confirmed that Datalabs is only licensed and supported by Parexel and that no other third-party organization has the capability to resell the required Datalabs software and maintenance support. Therefore, the results of this market research indicated that the required Datalabs licenses and software maintenance and support services are only available from the original software manufacturer with no resellers. Market research was also conducted on May 13, 2020 via a search of the Vendor Information Pages (VIP) database for North American Industry Classification System (NAICS) code 511210, Software Publishers, which indicated 435 Service-Disabled Veteran-Owned Small Business and Veteran-Owned Small Business vendors under that NAICS code. Even though 435 vendors were identified under that NAICS code Parexel confirmed that there are no other resellers of their services and no other vendors are authorized to provide the required licenses and software maintenance and support. An additional search of the VIP database for keyword “Datalabs” was conducted on May 13, 2020 which resulted in zero vendors.

9. Other Facts: None