75N94027R00003 EmbraceHEALTH CRN CC SSN 11.6.2026.pdf

Small Business Sources Sought Notice

Sources Sought Notice No.: 75N94027R00003

Title: EmbraceHealth Clinical Research Network (CRN) Coordinating Center

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) Monday, November 23, 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 and 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 a Research Coordinating Center (CC) 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.

mailto:jordan.neal@nih.gov mailto:gannon.white@nih.gov

EmbraceHealth CRN will comprise approximately five (5) Research Consortia (RCs) and a Research Coordinating Center (CC), with participating research and health care settings located in rural and urban areas across the United States and its territories. Each Research Consortium is expected to comprise multiple participating clinical and research sites. The CC will serve as the central resource for coordination, technical assistance, data infrastructure, analytic support, and cross-site collaboration across all RCs, ensuring that EmbraceHealth CRN activities are implemented in a consistent, rigorous, timely, and policy-compliant manner.

The EmbraceHealth CC shall serve as the integrated scientific, methodological, technical, and operational resource supporting multiple concurrent clinical, behavioral, and health services research studies across participating Research Consortia. Successful performance requires coordinated multidisciplinary expertise in clinical research, biostatistics, epidemiology, informatics, data science, regulatory support, safety reporting, and research operations, together with secure, scalable infrastructure for managing and harmonizing heterogeneous study and electronic health record data. The CC shall maintain the capacity to address differing study designs, clinical conditions, populations, intervention requirements, and timelines while supporting both consortium-specific research and network-wide collaboration. Responsibilities span protocol development, study readiness, implementation support, monitoring, analysis, biospecimen coordination, dissemination, close-out, and transition, as authorized under applicable task orders. Successful performance requires sustained integration of these capabilities, adaptation to evolving scientific and operational requirements, capability to support multiple studies concurrently, and continuity of support throughout the research lifecycle.

The network is anticipated to support multiple research studies over the contract period, including studies conducted by individual RCs and collaborative studies involving multiple RCs.

The number of participating sites, concurrent studies, and associated support requirements may vary depending on approved research protocols and program priorities. The CC must demonstrate the capacity to coordinate activities across the network and accommodate varying study requirements and workloads.

The Contractor shall establish and maintain the coordinating infrastructure and conduct coordination activities as elaborated below:

A. Support Core Research Operations and Research Infrastructure

The Contractor shall provide startup, coordination, and foundational support necessary to establish and maintain the Coordinating Center infrastructure and facilitate the readiness and effective operation of participating Research Consortia.

1. Core Research Operations and Project Management

a) Establish and maintain a Program Management Team responsible for coordinating CC activities, monitoring contract performance, overseeing CC subcontractors, and facilitating communication among NIMHD, participating RCs, and other collaborating organizations. The team shall include designated personnel responsible for program management, data coordination, statistical support, regulatory coordination as applicable, and financial and administrative management.

b) Develop and maintain a Network Operations Plan describing the organizational structure, key personnel responsibilities, communication procedures, coordination mechanisms with participating RCs, reporting requirements, performance measures, and processes for identifying and resolving operational issues. The plan shall be updated as necessary to reflect changes in network operations and approved procedures.

c) Establish standardized procedures for documenting, tracking, reviewing, and reporting protocol deviations and associated corrective and preventive actions (CAPAs). Participating RCs and their study investigators shall remain responsible for identifying and addressing deviations at their respective sites. The CC shall coordinate network-level tracking, assess recurring or systemic issues, and provide recommendations to NIMHD and the responsible study leadership. Approval of CAPAs and decisions concerning protocol modifications shall remain with the designated responsible parties under the applicable study protocol, monitoring plan, and regulatory requirements.

d) Provide specialized scientific, methodological, statistical, technical, and operational coordination and support to participating RCs in the development and implementation of RC-specific and collaborative research studies, as applicable. This shall include assisting with research protocol development and refinement; reviewing study designs, sample size considerations, and statistical analysis plans; coordinating the development of study-specific workflows, recruitment and retention plans, data collection instruments, quality assurance and quality control procedures, and reporting requirements.

e) Establish and maintain appropriate processes for monitoring study progress, including recruitment and enrollment, participant retention, data quality, protocol adherence, and achievement of study milestones, as applicable to individual studies. The Contractor shall coordinate cross-RC research activities when studies involve multiple RCs and facilitate the use of NIH-endorsed common data elements (CDEs), common procedures and data standards where scientifically appropriate. The Contractor shall support the RCs in the establishment and maintenance of core research operations, including completion and ongoing maintenance of all required trainings and certifications; implementation of research regulatory and oversight activities; development, refinement, and implementation of standard operating procedures (SOPs); coordination and facilitation of the development and execution of memoranda of understanding (MOUs), data sharing protocols, data use agreements (DUAs), and other required agreements in collaboration with participating RCs; and establishment of appropriate governance and oversight structures. These structures shall include, as applicable, a Data and Safety Monitoring Board (DSMB), and others necessary to ensure scientific rigor, participant safety, regulatory compliance, transparency, and meaningful community input. Other responsibilities may include coordinating meetings, preparing reports and interim analyses, maintaining meeting documentation, tracking recommendations, and communicating approved recommendations to designated parties. The DSMB shall provide independent recommendations regarding participant safety, study integrity, and study continuation, modification, or termination. Final decisions shall remain with the responsible sponsor or other authorized decision-making authority, as applicable.

f) Provide coordination to ensure consistent implementation of consortium-wide research activities. The Contractor shall establish and maintain centralized data management and coordination capabilities to support the secure receipt, validation, harmonization, analysis, and transfer of deidentified research data from participating RCs to NIH SCHARE, as applicable. The Contractor shall also coordinate biospecimen-related activities and transfers when required by individual study protocols and applicable task orders, in collaboration with participating RCs and designated repositories. This shall include finalization of research study protocols;

development of study workflows, recruitment and retention plans, data collection procedures, quality assurance/quality control processes, and reporting mechanisms;

and coordination of cross-RC research activities. The Contractor shall also support infrastructure to transfer deidentified study data (including extracted and harmonized electronic health record data, CDEs, relevant training documents, and others) from all RCs and to NIH SCHARE. Similarly, the Contractor shall coordinate, as applicable, transfer all biospecimens collected from each RC to a local repository or another repository identified by NIMHD r secure data/biospecimen transfer standards and requirements and in accordance with study protocols and task order requirements.

g) The CC shall coordinate and facilitate single Institutional Review Board (sIRB) arrangements for collaborative or multisite research studies, when required by applicable federal regulations and NIH policies. This shall include assisting participating RCs with the coordination of reliance agreements, submission requirements, protocol amendments, continuing review activities, and communication with the designated reviewing IRB, as applicable. The Contractor shall track required IRB approvals and related documentation to support timely study initiation and continued compliance with applicable human subjects protection requirements.

h) The CC will collaborate with the RCs on the research activities, as specified in the applicable study protocol, monitoring plan and task order, including review of all materials necessary for regulatory submissions in ongoing and future clinical trials conducted by the CRN or supported by the NIH, to ensure regulatory compliance and successful protocol implementation at RCs study activities. Clinical site monitoring regulatory rigorous studies shall include: visits after first patient enrolled, interim (as needed or as directed by the NIMHD COR), and close-out visits; assessment of the accuracy and completeness of case report forms, accuracy and completeness of source documentation, and all research records in accordance with Food and Drug Administration (FDA) regulations for clinical trials conducted under Investigational New Drug (IND) applications.

B. Support Study Implementation, Close-Out and Transition

The Contractor shall provide coordination, technical assistance, and operational support necessary to facilitate the implementation and close-out of approved research studies and ensure the orderly transition of study activities and resources across participating RCs.

1. Study Implementation

a) Develop standardized study startup procedures and tools to support participating RCs in preparing for execution of approved research protocols. These procedures shall address, as applicable, protocol-specific data management requirements, statistical analysis planning, regulatory documentation, safety reporting procedures, site training, data submission requirements, and readiness assessments. The CC shall coordinate these activities with participating RCs while maintaining the distinction between network-level coordination and RC responsibilities for clinical research site operations.

b) Provide coordination, technical assistance, and monitoring support necessary for the execution of approved RC-specific and collaborative research studies, as applicable.

The Contractor shall support participating RCs in recruitment and enrollment, intervention delivery and/or implementation, follow-up activities, clinical and research data collection, study monitoring, documentation, and adherence to approved protocols and SOPs.

c) Establish and maintain processes to monitor the timeliness, completeness, accuracy, and quality of study data submitted by participating RCs and coordinate the secure receipt, validation, harmonization, and transfer of required data to NIH SCHARE, as applicable. The Contractor shall also coordinate the transfer of biospecimens to designated repositories when required by individual study protocols and task orders, ensure timely and accurate collection of study data and transfer of required data/biospecimens from each RC 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.

d) Establish and maintain standardized procedures, systems, and reporting tools to support the collection, tracking, reconciliation, and reporting of adverse events (AEs), serious adverse events (SAEs), and other reportable safety information, as applicable to individual studies. The procedures shall identify the responsibilities of the RCs, study investigators, CC, NIMHD, Institutional Review Boards, and other responsible parties, including applicable reporting timelines and escalation procedures.

e) Establish an internal and public facing portal/website that will be used for communication with the EmbraceHealth CRN (i.e., RCs, CC and NIMHD) and the public. The internal portal will be accessible only to the EmbraceHealth CRN and will be primarily used for communication and coordination purposes. The external site will be for the general public to communicate general information about the EmbraceHealth CRN, the studies being conducted, newsworthy articles and other helpful contact information and items of potential interest. This portal/website shall be Section 508 compliant.

2. Study Close-Out Activities

a) The Contractor shall provide coordination and support of close-out activities for individual RC-specific and collaborative studies, as applicable, in accordance with the schedules and requirements established under the respective task orders. The Contractor shall coordinate with participating RCs to support 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. The Contractor shall review and verify, within the scope of the CC's responsibilities, the completeness and accuracy of study records and datasets, documentation, and analytic files received from participating RCs, and ensure that CC-maintained records and data are appropriately maintained or transferred in accordance with applicable policies and contractual requirements.

b) The Contractor shall coordinate the resolution of outstanding data queries, reconciliation of required study records, finalization of statistical datasets, completion of applicable safety and regulatory documentation, and preparation of study-specific closeout reports.

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, biospecimens, tools, workflows, and other resources to another entity, as directed by NIMHD, participating RCs, receiving entities, and other stakeholders to minimize disruption to ongoing or future research activities.

b) The Contractor shall develop a transition plan identifying ongoing studies, critical coordination activities, active data management systems, data dictionaries, outstanding data queries, applicable safety monitoring activities, pending deliverables, and procedures for secure transfer of CC-maintained records and resources.

c) The Contractor shall ensure the orderly and secure transfer of centralized data management systems, databases, data dictionaries, standard operating procedures, study coordination records, and other CC-maintained resources, as applicable, to support continuity of network operations and ongoing research studies. 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, receiving entities, and other stakeholders to minimize disruption to ongoing or future research activities.

Anticipated Period of Performance:

The anticipated ordering period for the resultant Indefinite Delivery, Indefinite Quantity (IDIQ) contract is approximately five years. Coordination activities in support of the Research Consortia will be conducted and specified on a task order basis.

Capability Statements:

To be deemed capable of providing the services needed for the EmbraceHealth CRN Coordinating Center, the respondent must submit a written capability statement that clearly demonstrates the following:

Respondents should describe how their proposed personnel, infrastructure, and anticipated teaming or subcontracting arrangements would integrate the scientific, statistical, technical, regulatory, and operational capabilities needed to support multiple concurrent studies with differing designs, populations, timelines, and requirements, identifying the capabilities they would provide directly and those they would obtain through other entities.

• Experience: Provide evidence of successfully coordinating or managing multi-site clinical research networks, data coordinating centers, or similar consortium-based research infrastructure, particularly involving populations experiencing health disparities. Describe experience providing biostatistical, epidemiologic, and data science consultation to multiple research sites; coordinating network-wide governance structures (e.g., Steering Committees, DSMBs); managing data use and data sharing agreements; and supporting study monitoring, quality assurance, and dissemination of findings across a network of sites.

• Facilities: The respondent must demonstrate that it has access to facilities, equipment, personnel, and administrative infrastructure necessary to conduct the coordination activities described above. Describe capabilities for secure, FISMA-compliant data management and transfer; Section 508-compliant website and data system development/maintenance; and biospecimen repository establishment, management, or coordination. Respondents that do not have in-house biospecimen repository capacity are encouraged to respond and should describe anticipated teaming or subcontracting arrangements to fulfill this capability; the absence of in-house repository capacity will not, by itself, be viewed as disqualifying.

• Other specific capabilities to be demonstrated are: Expertise in clinical research methodology, biostatistics, epidemiology, data science, informatics, and community/patient engagement across a multi-site network. Demonstrate capabilities for common data element selection and implementation, data harmonization across multiple sites, coordination with NIH SCHARE, and support for a single IRB of record. Describe the ability to coordinate network governance and committee structures, arrange and support DSMB meetings, track multi-site training and regulatory compliance, and comply with applicable NIH data sharing, privacy, and security requirements. Describe any experience establishing or managing a biospecimen repository, whether directly or through subcontracted biorepository partners.

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

General Information

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 and fax numbers, if available, 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.

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 Monday, November 23 at 4:00pm EST.

Please reference Notice Number "75N94027R00003" 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.