Clinical Data Management View and Download of Systems

1.0 DESCRIPTION:

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), Vaccine Research Center (VRC), intends to procure contractor support to provide continued read-only access, maintenance, security compliance, and subsequent decommissioning of the VRC websites and associated data systems. Services include maintaining the existing VRCReportingTool, VRCStudy website, VRC Data Warehouse, and Advantage eClinical platforms in their current state, administering user access, applying required security patches, performing system decommissioning at the end of the performance period, and providing optional data error investigation and correction services if exercised by the Government.

This acquisition is for a twelve-month period of performance for extended system access and support activities. Additionally, this acquisition will include six optional 40-hour Gap Analysis support tasks to investigate and resolve data discrepancies identified during migration or validation activities.

The Contractor shall provide continued operation, maintenance, secure read-only access, and subsequent decommissioning of the Vaccine Research Center (VRC) websites associated with the clinical trial data systems during the transition of VRC clinical trial data to an NIH-managed platform. The Contractor shall maintain the existing technical environment without introducing new functionality while ensuring the availability and integrity of historical data throughout the transition period.

The Contractor shall provide support for the following systems:

• VRC Reporting Tool
• VRC Study website (https://vrcstudy.com)
• VRC Data Warehouse (https://vrcreportingtool.org/)
• Advantage eClinical platforms

The publicizing of this notice is in accordance with Revolutionary Federal Acquisition Regulation (RFO) 5.101(a). This will be procured as a new award, based on the Contracting Officer’s determination that only one source is available to meet the Government’s requirements. The applicable North American Industry Classification System (NAICS) code is 541511 – Custom Computer Programming Services, and the associated small business size standard is $34 million.

2.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

The Emmes Company, LLC (Emmes) is the incumbent contractor supporting the VRC websites and associated data systems.  Emmes possesses unique technical knowledge and operational capabilities specific to the existing VRC websites and associated data systems. As the incumbent contractor responsible for the operation and maintenance of the VRCStudy website, VRCReportingTool, VRC Data Warehouse, and Advantage eClinical platforms, Emmes has established knowledge of the systems' architecture, configurations, user access controls, security requirements, hosting environment, and decommissioning processes. The requirement is to maintain these existing systems in their current state, provide secure read-only access, administer user accounts, apply required security patches, and execute an orderly decommissioning.

An assessment of commercially available sources was completed during market research to determine whether another contractor or authorized reseller could provide the required services. No alternative sources were identified that possess the technical knowledge, proprietary hosting environment, operational control, and system specific expertise necessary to maintain the existing VRCStudy website, VRCReportingTool, VRC Data Warehouse, and Advantage eClinical platforms through the required transition and decommissioning period. Commercial website access services are available; however, these offerings are not comparable because they are multi-tenant solutions that distribute costs across many customers. In contrast, the VRC requirement involves a dedicated, single-client environment with exclusive hosting, data management, security, and operational support.

Based on comparable competitive procurements and available commercial pricing, it is reasonable to estimate that engaging a new vendor to migrate, host, validate, secure, and maintain the VRC clinical trial data during the transition period would incur costs in excess of $1 million, which would not be in the best interest of the Government given that this a temporary requirement.

For the reasons detailed above, Emmes, is uniquely qualified to provide continued operation, maintenance, support, user access administration, read-only access, and planned decommissioning of the Vaccine Research Center (VRC) websites and associated data systems.  The cost, time, and operational risk associated with transitioning to an alternative provider within the available timeframe would be disproportionate to the duration and value of the requirement and would not serve the best interests of the Government.

3.0 RESPONSE INSTRUCTIONS

This notice is not a request for competitive quotations. However, all responsible sources may submit a capability statement, which will be considered by the agency. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow the Office of Mission Acquisition Solutions (OMAS) to determine in the party can fulfill the requirement. All responses must be sent via email to Whitney Monkam, Contracting Officer at whitney.monkam@hhs.gov by no later than 9:00AM EDT on August 10, 2026. A determination by the Government to not limit competition is based upon responses to this notice is solely within the discretion of the Government. To receive an award, contractors must be registered and have valid certification through SAM.gov. Reference HHS-OMAS-2026-06 on all correspondence.