3_SON_LabKey.pdf

Statement of Need (SON)

LabKey Server Premium Edition Enterprise License Renewal

Background

The NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) requires a renewal of the LabKey Server Enterprise subscription to support human clinical trial data aggregation, human health, and IT security. The platform serves as a centralized hub for the Division of Intramural Research (DIR), integrating data from various NIH systems and study teams to improve participant care and research insights. The current year work order number 19698019234, with LabKey expires 08/28/2026.

Purpose

LabKey provides yearly enterprise licenses on a Prepaid flat fee. The purpose of this acquisition is for NIAID to acquire 1 Enterprise license for one year, with a Subscription Period starting on 08/29/2026 and maintenance and support agreements starting after the current license expires.

Brand Name Product

NIAID requires LabKey licenses to maintain continuity of critical clinical studies (including the Centralized Sequencing Program, Protocol ID:17-I-0122). The platform provides the following unique capabilities:

• Integrated Data Modeling: A comprehensive data model capable of automating the integration of longitudinal data from multiple NIH sources to prevent manual spreadsheet entry and data silos.

• Out-of-the-Box Security Controls: Must include native IT security and regulatory compliance features, including automated data use audit trails, role-based access restrictions, and extensive system logging.

• Specialized Module Support: The platform must support specific research workflows, including:

• Clinical Study Management and Assay Data Management.

• Specialty Assays for Flow Cytometry, Mass Spec, and others.

• Ontology Annotation (exclusive to the Enterprise edition).

• System Interoperability: It o^ers native integration with Oracle, SQL Server, MySQL, and

Amazon Redshift, as well as external analytics tools like Tableau, RStudio, and RShiny.

This platform provides solutions to scientific operations and data management challenges, which include management of sensitive PHI and PII information to meet IT SECURITY controls required.

The COTS LabKey solution provides out-of-the-box IT security and regulatory compliance features that are configured by our administrator team to provide data use audit trails, secure data restricted to specific system roles, and provide extensive logging.

Currently, there are no alternative tools that meet NIAID and NIH’s technical and compliance requirements as defined by the Center for Information Technology (CIT) and custom development of a new platform would be costly and would increase operational risk and implementation complexity.

NIAID and NIH Impact

If the acquisition is not made, the impact would be significant. Without this comprehensive data model, the integration of longitudinal data from multiple studies would remain a manual process across several data sources and NIH systems. This traditional method is laborious requiring multiple members to enter data into spreadsheets and shared drives, which then need to be combined for analyses. This approach is not only cumbersome and time-consuming but also prone to errors, potentially leading to data silos and inconsistencies. If we don't use the COTS LabKey platform, it will be hard to evaluate and assure the IT security of the other methods mentioned earlier because they don't follow a standardized approach.