Attachment A - Statement of Work (SOW).pdf

EXHIBIT A

STATEMENT OF WORK

FOR

ACCESS TO DATABASE WITH CLINICAL TRIAL INFORMATION

02/19/2026

1.0 Introduction/Background

The Cancer and Data Science Laboratory (CDSL) is a research laboratory within the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), National Institutes of Health (NIH). CDSL was formed in early 2018 with the mission of developing and applying advanced computational approaches to analyze and integrate cancer laboratory and patient data. The laboratory addresses fundamental research questions related to cancer origin, evolution, progression, and treatment, and supports the cancer research community through data-driven analysis and collaboration with other CCR research laboratories.

To support this mission, CDSL requires access to a comprehensive clinical trials database that enables large-scale analysis of global oncology clinical trial design, execution, and outcomes. While publicly available tools and cohort-based databases exist, they do not provide the depth, update frequency, data export functionality, or publication rights required to support CDSL’s ongoing research activities. Access to a commercial clinical trials database that supports bulk data download, data snapshot (“freeze”) capability, and publication of derived analyses is essential to maintaining continuity of active research, ensuring data consistency across studies, and supporting the completion and publication of research currently underway.

2.0 Scope of Work

The contractor shall provide subscription-based access to a commercial clinical trials database that supports CDSL in conducting large-scale analyses of global oncology clinical trial design and outcomes. The scope of this effort includes furnishing user licenses that provide authorized Government personnel with continuous, uninterrupted access to the database for the duration of the Period of Performance.

The database shall enable analysis of clinical trial design, benchmarks, endpoints, outcomes, enrollment, timelines, and related trial characteristics across a broad range of oncology studies. Access shall support bulk data download and export functionality, including the ability to create static data “freezes” to support longitudinal and reproducible data analysis.

The database shall permit publication of research findings derived from summary-level trial data in peer-reviewed scientific journals.

The scope of work also includes all standard commercial services associated with the subscription, including system access provisioning, technical and end-user support, training resources, product updates, and maintenance, in accordance with the Contractor’s standard commercial practices.

3.0 Description of Tasks/Technical Requirements

3.1 Database Access and Functional Requirements

The contractor shall provide subscription-based access to a commercial clinical trials database that supports analysis of global oncology clinical trials. The database shall include a user interface that enables authorized Government users to search, filter, and analyze clinical trial information across a wide range of attributes, including, but not limited to, trial benchmarks, patient populations, endpoints, outcomes, geographic distribution, enrollment, and study timelines.

The database shall be updated no less than once each business day, defined as Monday through Friday, excluding Federal holidays.

The contractor shall provide functionality that allows authorized users to perform bulk data downloads for large numbers of clinical trials per download. Exported data shall be provided in a searchable electronic format, such as Microsoft Excel, suitable for large-scale data analysis.

The database shall support the ability for users to create static data snapshots (“freezes”) to enable longitudinal and reproducible analysis over extended periods of time using a consistent dataset.

The database shall include robust data fields related to biomarkers and genomic information, as applicable, and shall include cross-references to the original source materials from which the data were curated.

The database shall permit publication of research findings derived from summary-level trial data in peer-reviewed scientific journals. Any licensing restrictions that prohibit publication of such derived analyses are not acceptable.

3.2 User and Technical Support

The contractor shall provide technical support, maintenance, and end-user support for the database throughout the Period of Performance. Support services shall include, at a minimum:

• End-user support via a mechanism for asking questions in the system, email, and/or telephone

• Willingness to investigate and correct data errors identified by users

• Ability to respond to scientific or data-related questions regarding the correspondence between curated data and original peer-reviewed publications

• A mechanism for users to submit debugging or data issue requests

The contractor shall provide access to online training and troubleshooting materials, such as user guides, webinars, or knowledge bases.

The contractor shall provide product release announcements, lifecycle notifications, and key feature updates to users via email.

The contractor shall provide major version upgrades and patches at no additional cost to the Government, implemented in accordance with the Contractor’s standard commercial practices.

Technical support, via the Ask the Analyst feature, shall be available on weekdays with a reliable 24-hour turnaround time for any questions or problems submitted.

3.3 License Provisioning and Access

The contractor shall provision user licenses and provide access credentials to authorized Government users within one (1) business day of the effective date of award or license activation.

The contractor shall provide any necessary instructions to facilitate user registration and access to the database.

No software installation on Government-owned equipment shall be required.

3.4 Training

The contractor shall provide live, virtual training for end users within ten (10) business days after activation of licenses.

The contractor shall provide users with access to any available training resources, including prerecorded webinars, documentation, or user guides, throughout the Period of Performance.

4.0 Deliverables

The contractor shall provide the following deliverables in support of the TrialTrove software subscription. All deliverables shall be provided electronically unless otherwise specified.

Item No. Deliverable Description Quantity Due Date Delivery Instructions

4.1

User license access to the TrialTrove database for authorized Government users

Within one (1) business day of award or license activation

Access credentials and instructions provided electronically to the Contracting Officer’s Representative (COR)

4.2 User access documentation and login instructions

Within one (1) business day of license activation

Provided electronically

Item No. Deliverable Description Quantity Due Date Delivery Instructions

4.3 Live virtual end-user

training session 1

Within ten (10) business days of license activation

Conducted virtually; training materials provided electronically

4.4 Ongoing technical and

user support services Ongoing

Throughout the Period of Performance

Provided in accordance with the Contractor’s standard commercial support practices

4.5 Product updates, patches, and version upgrades

As released

Throughout the Period of Performance

Provided at no additional cost to the Government

5.0 Type of Order

This is a Firm-fixed-price Task Order (TO) for commercial electronic information technology (EIT) software licenses and associated subscription services. Services shall be delivered in accordance with this Statement of Work (SOW).

5.1 Severable Services

The services delivered by the contractor under this Task Order are severable services. Funds are available only for use for the contract line item number (CLIN) for which they are obligated. Unused funds from one period of performance or CLIN may not be used for or “rolled over” to other periods of performance or CLINs.

6.0 Period of Performance

The Period of Performance is a 12-month base period and four (4) 12-month option periods.

7.0 Inspection and Acceptance

Pursuant to FAR clause 52.212-4, all work described to be delivered under this Task Order is subject to final inspection and acceptance by the COR.

All deliverables delivered to the COR will be deemed accepted thirty (30) calendar days after the date of delivery, except as otherwise specified in the Task Order, if written approval or disapproval has not been provided within such period. The Government’s approval or revision to the services delivered shall be within the general scope of work stated in the Task Order.

8.0 Payment

Payment shall be made upon delivery and acceptance of services.

Payment authorization requires submission and approval of invoices in accordance with the Prompt Payment Act and FAR clause 52.232-25, Prompt Payment, as implemented by NIH and HHS procedures. Invoices shall be submitted electronically through the Department of the Treasury’s Invoice Processing Platform (IPP), unless otherwise authorized by the Contracting Officer.

9.0 Contract Clauses

This Task Order incorporates by reference FAR 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services, and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Products and Commercial Services, along with applicable HHSAR clauses.

In the event of a conflict between Contractor-provided terms and conditions and Government-provided provisions and clauses, the Government-provided provisions and clauses shall control.

Additional clauses and provisions applicable to this Task Order may be incorporated in the award document.