75N94027R00002 EmbraceHEALTH CRN SSN 11.4.2026.pdf

Small Business Sources Sought Notice

Sources Sought Notice No.: 75N94027R00002

Title: EmbraceHEALTH Clinical Research Network (EmbraceHEALTH CRN)

Type: Research and Development (R&D) Sources Sought

NAICS Code: 541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Response Date: 4:00PM (Eastern) Thursday November 19, 2026.

Primary Point of Contact: Jordan Neal, Contract Specialist – jordan.neal@nih.gov

Secondary Point of Contact: Gannon White, Contracting Officer – gannon.white@nih.gov

Description:

This is a Small Business Sources Sought (SBSS) Notice for Research & Development (R&D). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified small businesses under the size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The anticipated North American Industry Classification System (NAICS) code is 541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), and the small business size standard for such requirements is 1,000 employees or less, including applicable affiliates.

This SBSS notice is for market research and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The purpose of this synopsis is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement, this acquisition may be solicited as a small business set-aside. All small business organizations (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background and Project Requirements:

The National Institute on Minority Health and Health Disparities (NIMHD) within the National Institutes of Health (NIH) seeks capability statements from interested and qualified potential sources to establish and operate Research Consortia (RCs) within the EmbraceHEALTH Clinical Research Network (EmbraceHEALTH CRN). The purpose of the network is to conduct solutions-oriented clinical and behavioral research to improve clinically meaningful and measurable health outcomes and reduce health disparities.

EmbraceHEALTH CRN will be comprised of multiple Research Consortia and a Research Coordinating Center (CC), with participating research and health care settings located in rural mailto:jordan.neal@nih.gov mailto:gannon.white@nih.gov and urban areas across the United States and its territories. Research Consortia will consist of collaborations or partnerships between organizations, including but not limited to academic institutions, health care settings, and other entities that provide ambulatory care, including family medicine, general internal medicine, general pediatrics, and medical subspecialties with a component of chronic ambulatory care.

Partnerships involving academic health centers serving patients from low-income backgrounds or low-resourced communities, community health care settings linked to safety net hospitals, and Federally Qualified Health Centers are of particular interest.

Respondents must demonstrate the organizational capacity, healthcare partnerships, and research infrastructure necessary to access and recruit a scientifically meaningful proportion of patients from populations and communities experiencing health disparities, including individuals from low-income backgrounds, low-resourced communities, and those with public health insurance (Medicare, Medicaid, CHIP) or no insurance. Respondents should describe the characteristics of their patient population sufficient to support sound analyses by age, sex, and racial/ethnic group.

The Government is seeking organizations with the capability to design, develop, and conduct rigorous, hypothesis-driven clinical, behavioral, and health services research prioritizing solutions-oriented interventional studies on a task order basis. Studies shall address chronic, acute, urgent, and emerging health needs of populations and communities experiencing health disparities throughout the United States and its territories. Study designs may include randomized controlled trials, cluster randomized trials, pragmatic trials, comparative effectiveness research, implementation research, hybrid effectiveness-implementation trials, adaptive trials, and other appropriate designs specified in individual task orders.

As the EmbraceHealth CRN infrastructure is established, future studies on emerging, urgent, chronic, and acute conditions and/or associated risk factors, biomarkers, genetics/omics, or epigenetics/omics could be implemented. In addition, data science and super intelligence (SI) research on causal inference, machine learning, longitudinal data, and implementation science could be further explored. The goal of these evolving research initiatives conducted through the EmbraceHealth CRN is not simply to predict who is at high-risk, but to estimate what interventions might work, for whom, under what circumstances, and at what point in a patient’s care trajectory.

Through the EmbraceHealth CRN, NIMHD seeks to identify and facilitate innovative research on reducing health disparities via technology-based studies, especially those that enhance patient self-reported data, interaction with clinicians and the health care system, and home-based biospecimen collection, remote monitoring, treatment and/or self-management.

EmbraceHealth CRN funded projects are envisioned to generate findings with the potential to inform formal implementation or revision of clinical practices, guide further research on implementation or scaling up, or generate new hypotheses for future studies.

Specifically, a capable organization shall be able to perform the following activities:

Task Area A: Core Research Operations and Research Infrastructure

Task Area A shall encompass all start-up and foundational activities required to prepare for the successful conduct of EmbraceHealth CRN studies.

1. Core Research Operations and Project Management

Establish and maintain core research operations, necessary to support the performance of awarded task orders. Finalize, implement and maintain, a Project Management Plan that identifies the organizational structure, staffing, roles and responsibilities, lines of authority, management of subcontractors and consultants, communication procedures, milestones, workflows, and processes for monitoring progress and addressing delays or performance issues.

2. Research Regulatory Compliance

The contractor shall ensure completion and maintenance of all required training and certifications. Clinical trials shall be conducted in accordance with FDA regulations and Good Clinical Practice (GCP) requirements, and human subjects research shall comply with regulatory and organizational review requirements as applicable.

The Contractor shall establish procedures for protecting participant safety, privacy, and confidentiality; obtaining and maintaining required research approvals; identifying, documenting, and reporting adverse events and serious adverse events, as applicable;

and tracking required personnel training and certifications; development, refinement, and implementation of standard operating procedures (SOPs); execution of memoranda of understanding (MOUs), data sharing protocols, data use agreements (DUAs), and other required agreements in collaboration with the CC and participating RCs; and establishment of appropriate governance and oversight structures.

3. Governance and Oversight

Establish or participate in appropriate governance and oversight structures. These structures shall include, as applicable, a Data and Safety Monitoring Board (DSMB), a local Community Advisory Group, and other structures necessary to ensure scientific rigor, participant safety, regulatory compliance, transparency, and meaningful community input.

4. Research Infrastructure and Personnel

The Contractor shall provide the requisite expertise and research infrastructure to support and execute the research studies and consortium-wide activities, including scientific, technical and clinical experts and other qualified personnel necessary to support the research infrastructure and activities.

5. Protocol Development and Study Preparation

Participate in the development, refinement, and finalization of research study protocols and development of study workflows, recruitment and retention plans, data collection procedures, quality assurance and quality control processes, reporting mechanisms, and coordination with the CC and other RCs on cross-site research activities as applicable.

The Contractor shall support the development of scientifically rigorous study protocols that identify research questions or hypotheses, specific aims, study design, target populations, sampling approaches, primary and secondary outcomes, analytic methods, and procedures for evaluating intervention fidelity, feasibility, and scalability, as applicable to the research requirements.

Where required by the applicable task order, the study design and analytic plan shall address appropriate representation and assessment of outcomes among relevant population subgroups, including sex and racial or ethnic groups, consistent with the scientific objectives and applicable requirements.

6. Data Management Infrastructure

Establish and maintain the requisite infrastructure and capabilities necessary to securely collect, extract, harmonize, manage, and transfer deidentified study data (including extracted and harmonized electronic health record data, CDEs, relevant training documents, and others) to the CC and the NIH Science Collaborative for Heath and Artificial Intelligence Reduction of Errors (SCHARE), and biospecimens to the CC or another biorepository identified by NIMHD, following secure data/biospecimen transfer standards and requirements.

The Contractor shall establish and maintain appropriate data management procedures and systems, including data entry, validation, quality control, cleaning, editing, dataset finalization, secure storage, and transfer. The Contractor shall maintain appropriate interfaces between participating healthcare systems, academic institutions, and designated research data systems, as required.

The Contractor shall develop and implement an applicable Data Management and Sharing Plan addressing the management, preservation, access, and sharing of research data in accordance with NIH requirements and approved study protocols.

Information systems used in contract performance shall comply with applicable federal information security, privacy, and contractual requirements, including FISMA-related requirements when applicable to the system and its use.

7. Biospecimen Infrastructure

Establish and maintain the capabilities necessary for biospecimen collection, processing, storage, and transfer to the CC or another biorepository identified by NIMHD, when required by the applicable task order and approved study protocol.

The Contractor shall maintain procedures for biospecimen identification, handling, tracking, quality control, storage conditions, and secure transfer, as applicable to the approved research protocol.

8. Community Engagement

Establish and maintain appropriate mechanisms for engaging participating communities, patients, and other relevant stakeholders in research activities, as applicable to the approved study protocols and consortium objectives.

The Contractor shall provide ongoing consultation and periodic updates to the NIMHD Contracting Officer's Representative (COR) regarding emerging health needs, changing community conditions, research priorities, and potential future research opportunities relevant to the populations and communities served.

The Contractor shall coordinate with the local Community Advisory Group and participating healthcare partners to support appropriate community input, culturally and contextually responsive recruitment strategies, and communication with study participants and communities.

Task Area B: Study Implementation, Close-Out, and Transition

Task Area B shall encompass all study implementation activities, including study close-out and transition of resources of EmbraceHealth CRN studies.

1. Study Implementation

a. Conduct approved research projects authorized under awarded task orders in accordance with approved protocols, study implementation plans, and applicable research requirements.

b. The Contractor shall implement the approved research design, including sampling, randomization, intervention assignment, outcome measurement, and follow-up procedures, as applicable. Implement applicable participant recruitment and enrollment, intervention delivery or implementation, retention, follow-up activities, clinical and research data collection, study monitoring, documentation, and adherence to approved protocols and SOPs.

c. The Contractor shall ensure timely and accurate collection of study data and transfer of required data/biospecimens to the NIH SCHARE, the CC or another biorepository identified by NIMHD, in accordance with approved data sharing protocols, DUAs, privacy and security requirements, and NIH policies.

2. Study Close-Out Activities

a. Prepare and submit required technical reports, study data, documentation, and other required deliverables, as specified in applicable task orders that include, but are not limited to, finalization and documentation of all informatics, technology, and data transfer SOPs; completion of data extraction, harmonization, validation, and transfer for all studies; resolution of data/biospecimen queries; final study monitoring and quality assurance activities; completion of required regulatory and administrative close-out procedures; and submission of final deliverables to NIMHD and the CC. Final deliverables shall include, as applicable, completed datasets, data dictionaries, documentation of data validation and quality control, final analyses, study findings, and records necessary to support required data sharing and research dissemination.

b. The Contractor shall ensure that study records, datasets, documentation, and analytic files are complete, accurate, and maintained or transferred in accordance with applicable policies and contractual requirements.

3. Transition of Study Activities and Resources

a. The Contractor shall perform activities necessary to ensure an orderly transition of study activities, data, documentation, materials, tools, workflows, and other resources to another entity, as directed by NIMHD, when applicable.

The Contractor shall support continuity of operations by preparing transition plans, transferring relevant knowledge and documentation, assisting with data and resource migration, and coordinating with NIMHD, the CC, receiving entities, and other stakeholders to minimize disruption to ongoing or future research activities.

NIMHD anticipates research addressing chronic health conditions associated with significant morbidity and mortality among populations experiencing health disparities. Conditions may include cardiovascular and cardiometabolic diseases, cancer, asthma and other chronic pulmonary conditions, sleep disorders, chronic liver and kidney diseases, cognitive impairment and dementia, mental health conditions, substance use disorders, HIV/AIDS and associated complications, pregnancy-related disorders, and other conditions identified by participating communities. Acute or urgent health conditions may also be addressed.

Anticipated Period of Performance:

The anticipated ordering period of each resultant Indefinite Delivery, Indefinite Quantity (IDIQ) contract is approximately five years. Research activities and respective performance periods will be conducted and specified on a task order basis.

Capability Statements:

To be deemed capable of providing the services required for the EmbraceHEALTH CRN Research Consortia, the respondent must submit a written capability statement that clearly demonstrates the following:

• Experience: Provide evidence of successfully designing, conducting, managing, and completing clinical and behavioral intervention studies in real-world health care settings, particularly studies involving populations experiencing health disparities. Describe experience with participant recruitment and retention, community engagement, coordinating centers, multi-site collaboration, research oversight, study monitoring, and dissemination of findings. Include relevant experience evaluating stress-reduction interventions, if available.

• Facilities: The respondent must demonstrate that it has the requisite facilities, equipment, clinical partnerships, personnel, and administrative infrastructure necessary to conduct the research activities described above. Describe access to ambulatory health care settings and appropriate participant populations, including established partnerships with academic institutions, safety net health care settings, or Federally Qualified Health Centers.

• Other specific capabilities to be demonstrated include: Expertise in clinical research methodology, relevant clinical specialties, biostatistics, implementation science, data science, informatics, and community or patient engagement. Demonstrate capabilities for electronic health record extraction, common data elements, data harmonization, secure data management and transfer, biospecimen collection and shipping, and collaboration with a coordinating center. Describe the ability to comply with applicable research oversight, participant protection, privacy, security, and NIH data sharing requirements, and to support study close-out and transition activities.

***NOTE: General “brochures” will not be considered***

A responsive submission should address and incorporate all the following information:

General Information

Small businesses that believe they have the ability to satisfy all of the Project Requirements as described above, and who meet the stated size standard, are encouraged to submit a capability statement demonstrating their relevant expertise. Respondents will not receive individualized feedback.

Capability statements must include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and email addresses.

Respondents shall identify their small business status under the anticipated NAICS code and any applicable socioeconomic designations. If performance would involve teaming partners, subcontractors, or consultants, describe their anticipated roles and identify which capabilities the respondent would provide directly.

Commercial Availability of Services

Based on preliminary market research, the Government anticipates that the contemplated research services may be non-commercial in nature. However, interested respondents are encouraged to identify comparable services available in the commercial marketplace. If such comparable services are available commercially, describe which portions of the requirement might be met commercially and which would require customization, integration, or specialized development. Provide supporting information, including customary pricing practices and potential firm-fixed-price arrangements, if available.

Information Submission Instructions:

All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically via email to Jordan Neal, Contract Specialist, at Jordan.neal@nih.gov and Gannon White, Contracting Officer, at gannon.white@nih.gov, in either MS Word or Adobe Portable Document Format (PDF), by Thursday, November 19 at 4:00pm EST.

Please reference Notice Number “75N94027R00002” on all correspondence. All information furnished must be in writing. Questions must be in writing and emailed to the Contracting Officer and Contract Specialist.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback regarding any information submitted. After a review of the responses received, a solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Any determination regarding competition or a small business set-aside will be made by the Government.

Confidentiality:

Responses to this notice should not include proprietary, classified, confidential, or sensitive information.