Draft_Biomedical_SOW_1_10_24_1.pdf

Biomedical Data Computing Support Services

Statement Of Work

A. BACKGROUND AND OBJECTIVES

The Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) conducts broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in cancer epidemiology and genetics across NCI, National Institutes of Health (NH), and the global research community.

The goal of this acquisition is to identify biomedical data computing services in support of the ongoing research programs conducted in DCEG and other divisions of the NCI. DCEG programs include domestic and international studies with diverse study designs in epidemiology and genetics research including prospective cohort studies, case-control studies, family studies, and randomized clinical trials. These studies span several geographic areas (potentially in any continent), are of varying size and complexity, and include dense, high-dimensional data on exposures, endpoints, clinical information, and biomarkers from molecular technologies.

B. DESCRIPTION FOR INDIVIDUAL TASK AREAS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the work as defined below. The Contractor shall coordinate and integrate all activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts for task orders which will include one or more of the task areas as defined below. As much as possible, the management of data assets and configuration of computational services should be programmatically interoperable with NCI cloud infrastructure.

B.1. Task Area A: Contract Initiation/Kick-Off

The goal of this Task Area is to establish the necessary integrated infrastructure and procedures for effective communication for the period of the contract. Activities performed by the Contractor include, but are not limited to:

1. Establish a consistent method of invoicing and reporting that tracks labor hours to a study/project identifier and to the requestor and provides detailed reports of the work completed within the period of performance. [Note: The minimum level of information that shall be required is defined in the Additional Business Proposal Instructions.] This method shall be flexible to accommodate for any changes to NIH, NCI and Division business needs that may occur in the future; including, but not limited to, changes to the process of submitting invoices using web-based systems.

2. Establish a method for data and knowledge transfer from incumbent contracts/orders, as required.

3. Establish a method to allow Division investigators and staff access to status reports and invoices for contract-related charges as real-time as technically feasible, as discussed with the COR. This method shall be flexible to accommodate for any changes to NIH, NCI and Division accounting systems or processes that may occur in the future.

4. Provide a summary of capabilities to the Contracting Officer’s Representative (COR), including a menu of services offered. Summary shall include the labor categories required and corresponding rates for each service for the purpose of informing all Division staff of the expertise and expected cost of the Contractor.

5. Attend meetings and/or seminars to present capabilities, as required by the COR.

B.2. Task Area B: Biomedical Data Modeling, Data Acquisition and Management

Under Task Area B, the Contractor shall perform all activities necessary to provide biomedical data management support including manual and automated secure and standardized processes to enter, store and retrieve data and documents for research studies. This support may include, but is not limited to, studies which: a) vary by size and study design; b) include diverse data variables from diverse sources; and c) involve data exchange with multiple collaborators/repositories.

Activities performed by the Contractor shall include, but are not limited to:

1. Transition all activities and services from an incumbent contractor.

2. Provide data modeling, acquisition, and management services for studies with diverse variables, clinical and laboratory data, including environmental exposure (radiation, nutrition, microbial, hormonal, and others), occupational exposure/industrial hygiene parameters, demographics, medical history (i.e., clinical signs, imaging), and high-dimensional molecular data from biospecimens. It is expected that data will increase in size and complexity due to ongoing data collection efforts and additional data generated from molecular technologies (e.g., sequencing, tissue imaging). This shall correspond with scalable computational infrastructure, when possible, leveraging Cloud Computing made available by NIH programs such as STRIDES).

3. Provide services to store and manage data from diverse sources including data collection instruments such as questionnaire surveys, hospital/clinic medical record databases, pathology reports, laboratory results, death certificates, public records of environmental exposures, biospecimen inventory systems, or other databases including cancer registries and the National Death Index, which require standardized processes for data collection. Data storage services shall be configured, whenever possible, with interoperability with NCI and Division infrastructure to enable subsequent aggregation of data.

4. Provide support to collect and maintain field-data with appropriate workflows and built-in mechanisms to help monitor the progress and accuracy of project-specific work.

5. As defined by the COR, store and annotate study data variables, including molecular data, to facilitate interpretation of such data in the context of biological information.

This includes, but is not limited to, coding services for categorizing information based on demographic, reproductive, medical, radiation, occupational, or lifestyle factors, as well as complex laboratory or genetic data. The Contractor shall provide instruction manuals to ensure consistent coding and to minimize errors in transcription and to enable automated entry where possible.

6. Implement effective and innovative data management techniques that are optimized to enable efficient data retrieval for downstream integrative analyses of data from studies with complex and evolving study-designs, complex variables, and high-dimensional data variables. This should include the ability for NCI investigators and Contractor staff to directly access, retrieve and/or analyze multiple data sets for a study in a comprehensive way, using appropriate, best-in-class business intelligence (BI) tools.

7. Implement standardized processes for timely, accurate and efficient data exchange with NCI investigators, collaborators, and third-party Contractors, as authorized by the NCI Principal Investigator and as directed by the COR. In some cases, collaborators include large cooperative groups or research consortia. The Contractor shall also facilitate routine exchange of data with data repositories.

8. Maintain data and associated documentation in an efficient way to foster transition of data from the Contractor’s infrastructure to an NCI Principal Investigator or third-party Contractor with minimal effort. Ensure that data systems being used employ fast read/write capabilities and possess storage/processing capabilities to enable efficient storage, retrieval, and analysis of the data.

9. As agreed upon by the COR, implement robust, comprehensive, periodic, and coordinated quality control (QC)/quality assessment (QA) plans and an updated/versioning strategy to accommodate the volume and diversity of data collected, ongoing updates, and to enable diverse types of data usage.

10. Provide reliable, scalable data storage and computing infrastructure with built-in redundancies, as well as automated, reliable, and secure back-up and recovery procedures for all data, tools, and services the Contractor is hosting, analyzing, and providing for NCI. Support for cloud-based systems and services is expected, wherever possible, including programmatic interoperability mechanisms in line with the Findable Accessible Interoperable Reusable (FAIR) Guiding Principles of data management and stewardship. Data management tasks may include data that contains Personally Identifiable Information (PII) and thus should be handled in accordance with the Federal Information Security Management Act (FISMA) law and all DHHS, NIH and NCI standards, regulations, guidelines, and policies.

11. Assistance with making data ready for sharing per the NIH data management and sharing policy.

12. Explore Government, commercial and/or open-source solutions, including FedRAMP-authorized cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

13. Provide, as required, staff with appropriate expertise to address the requirements as defined in each Task Order and coordinate training and certification for all Contractor staff, as required.

14. Ensure quality assessment and quality control of the work performed, as required, fostering excellent internal/external communications, tracking projects, and monitoring the budget.

15. For planning purposes, the Contractor shall provide details of the work required to complete a requested task to the NCI requestor and COR, within the timeframe discussed for each task order, as required. The documentation shall be provided in a summary and detailed format and must be clear, and easily available to the requestor.

16. Work cooperatively with the NCI and relevant NCI third-party Contractors, as defined by the COR, in all relevant aspects of project management and execution to maximize cost-effectiveness and efficiency. NCI will prioritize the order of tasks and activities.

17. Provide general program support in planning, managing, and reporting for this contract.

This includes, but not limited to, project and risk management for the task orders.

B.3. Task Area C: Data Analytics, Statistical and Bioinformatic Analysis and Tool Development

Under Task Area C the Contractor shall perform all activities necessary to provide statistical programming, analytic support, and tool/software development for NCI research studies.

Activities performed by the Contractor shall include, but are not limited to:

1. Prepare analytic datasets for derived variables and associated documentation.

2. Provide knowledgeable and skilled staff for statistical programming and analysis support of data from studies like those described in the Background (Section A) of this document.

3. Provide support for preparation of routine and ad hoc reports that may draw on information from one or more systems managed by the Contractor or the NIH, as defined by the COR.

4. Provide support for manuscript preparation including independent verification of analysis performed by NCI investigators, and production of tables, charts, figures, and specialized graphics as requested.

5. Provide routine statistical programming and analysis of epidemiological data.

6. Provide statistical and bioinformatics analyses of data resulting from molecular technologies.

7. Develop new analytical approaches/models for data analysis and study design. Such development of new methods may require simulations to test theories underlying new algorithms and validate the proposed method, or to compare these with existing ones.

8. Maintain flexibility to accommodate analysis in a variety of packages, including but not limited to, newer molecular technologies and methods to perform analyses of the data from these technologies.

9. Maintain flexibility to be able to deliver data in many formats, as defined by the COR.

10. Provide support, as required, in a manner that assigns expertise to the requested task and does not assign individuals to specific studies or the Branches. Underlying work documentation and resources shall be made available to increase efficiency in performing tasks and avoid duplication of effort.

11. Streamline communication and information sharing between the Contractor and NCI staff to harmonize similar analytic and programming efforts and remove duplication of work, to whatever extent possible.

12. Provide documentation of all software and tools to provide an understanding of how the product was developed and is to be used.

13. Provide all statistical programming and analytic coding to the NCI for future use.

14. Maintain and enhance software systems with version control, as well as websites and tools previously developed. Examples of such tools can be found at:

https://dceg.cancer.gov/tools, git-based versioning services such as GitHub are generally recommended.

15. Develop all systems and websites in compliance with federal regulations and adhere to NCI templates wherever feasible. This includes, but is not limited to, Section 508 compliance, where applicable.

a. This contract includes, but is not limited to, the following Information and Communication Technology (ICT) products or services:

i. Electronic Documents (including but not limited to Microsoft Word and Excel, Microsoft Outlook email, CSV, PDF files, and more.)

ii. Intranet or Internet Services | Section508.gov

iii. Web-based Information, Documentation and Support

b. While NCI can only explicitly reference the above-named ICT under this IDIQ, other ICT, and applicable Section 508 standards Web Accessibility Initiative (WAI)

| W3C WCAG guidelines will be identified for each specific Task Order as they are invoked.

16. Comply with all DHHS, NIH and NCI policies, guidelines, and regulations, in accordance with Section H of the contract.

17. Maintain interoperability and compatibility with any existing or planned IT systems.

18. Ensure that no existing federal, HHS, or NIH system can be leveraged, reused and/or slightly modified where possible to meet the mission need [i.e. no Government Off-the- Shelf (GOTS) solution]. If no GOTS solution will meet the requirement, the Contractor shall explore the use of commercial and/or open-source solutions, including FedRAMP-authorized cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

https://www.section508.gov/sample-procurement/electronic-documents https://www.section508.gov/sample-procurement/intranet-or-internet-services/ https://www.section508.gov/sample-procurement/web-based-information-documentation-and-support https://www.w3.org/WAI/ https://www.w3.org/WAI/

19. Coordinate and integrate all Task Order activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts.

20. Provide, as required, staff with appropriate expertise to address the requirements as defined in each Task Order and coordinate training and certification for all Contractor staff, as required.

21. Ensure quality assessment and quality control of the work performed, as required, fostering excellent internal/external communications, tracking projects, and monitoring the budget.

22. Provide an estimate of the time to complete the task and the accompanying documentation to the NCI COR, within the timeframe defined within the task order, as required. The documentation must be provided in a summary and detailed format and must be clear, and easily available to the requestor. Estimates of the budget to perform the task shall be provided by the Contractor at the discretion of the task requestor.

23. Work cooperatively with the NCI and relevant NCI third-party Contractors, as defined by the COR, in all relevant aspects of project management and execution to maximize cost-effectiveness and efficiency. NCI will prioritize the order of tasks and activities.