Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

Sources Sought Notice Information

Introduction

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding:

1. 1. the availability and capability of qualified small business sources;
   2. whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and
   3. their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. This mission is driven by two strategic aims: addressing major infectious diseases, including emerging and chronic infections, and tackling immunologic and allergic disorders. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices, and diagnostics, which are funded through a variety of research grants and contracts.

Through multiple grant- and contract-funded research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 0-4 clinical trials of therapeutics, including both novel agents and repurposed therapies; vaccines, new vaccine formulations, schedules, and modes of delivery; natural history and cohort studies for pathogens of interest; and evaluation of novel diagnostics for selected infectious diseases. These clinical research activities are focused on the improved diagnosis, treatment, and prevention of emerging, infectious, and chronic diseases for public health priorities that address the needs of the United States (U.S.) population.

Purpose and Objectives

The U.S. Government has a requirement for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support DMID’s extramural clinical research programs.

Project Requirements

The project requirements of the SDCC include: 21 CFR Part 11-compliant clinical data management systems for the collection, storage, management, reporting and quality control of study data; preparation of study-related materials; clinical study websites; statistical design and analysis expertise; data management user training; support of study operations, clinical site capability assessment for data management; electronic specimen tracking system; data storage facility; and project/site management.

Anticipated Period of Performance

The Government anticipates making one (1) contract award. It is anticipated that the duration of the contract will be a maximum of seven (7) years.

Other important considerations:

Where permissible and appropriate, incorporation of Artificial Intelligence (AI) across the functions of the SDCC are anticipated to be permitted, while enforcing safeguards for participant privacy and regulatory compliances, in alignment with NIH policies and guidances, including Office of Science Policy’s (OSP) Artificial Intelligence in Research: Policy Considerations and Guidance. Final decisions affecting clinical data shall remain subject to documented human review and quality control.

Respondents lacking the expertise to address all the technical requirements are encouraged to identify collaborations and partnerships that, through combined expertise, can address all these technical requirements.

Capability Statement/Information Sought

Interested Sources are expected to have the expertise, personnel, and facilities to meet the requirements of the project. Tailored Capability Statements submitted as a result of this notice shall demonstrate and document the offerors’ qualifications and experience, specifically providing evidence as to its capability to perform this requirement, with particular attention to the following technical areas:

1. Ability to operate and maintain a state-of-the-art 21 CFR Part 11-compliant clinical data system for the collection, management, storage, and reporting of clinical and non-clinical data.
2. Ability to ensure the accuracy, completeness, and timeliness of all data entered into the clinical data management system.
3. Ability to provide clinical trial statistical design and analysis functions for Phase 0-4 clinical trials evaluating therapeutics, vaccines and devices for a wide variety of chronic and infectious diseases.
4. Ability to conduct the preparation, writing, and distribution of the protocol and other study-related materials.
5. Ability to communicate and collaborate with NIAID, grant recipients and contractors, and other study collaborators to facilitate clinical research activities.
6. Ability to facilitate study operations and regulatory requirements through reporting and analytics, and facilitate NIAID’s requirements for oversight and performance monitoring of clinical sites and clinical research activities.
7. Ability to provide training of clinical site personnel and other collaborators on all aspects of clinical data management.
8. Ability to operate and maintain a specimen tracking system.
9. Ability to operate and maintain a secure data storage system.
10. Ability to distribute study data and metadata to NIH- and NIAID-designated repositories and other collaborators.

Technical Plan/Approach: appropriateness and adequacy of the plans for conducting all the activities described above.

Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity.

It is estimated that 60 Full-Time Equivalents (FTEs) will be required for each year of the proposed contract. For the purposes of this notice, a Full-Time Equivalent is one (1) person- whether contractor employee, subcontractor employee, or consultant-who works 2,080 hours per year.

It is anticipated that the Government may exercise Options for increased level of effort that may result from unanticipated increases in demand, with the services required under the Options to be of the same scope provided during the Base year. Should the Government elect to exercise any of the Options, the Options may be exercised within the Base period (and within each year of the proposed contract), up to a maximum of additional 90 FTEs.

Facilities/Resources/IT Security: adequacy and appropriateness of the facilities and resources dedicated to the project.

AI oversight: appropriateness and adequacy of the plans to ensure AI-enabled tools and systems are subject to documented human review and quality control.

Past Performance: Past performance is considered essential. In addition to demonstrating that an offeror has met the above qualifications, interested parties must identify at least three (3) other projects of similar size and complexity.

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper. Print setup should be single sided on standard letter size paper (8.5” x 11” in the U.S., A4 in outside the U.S.). All proprietary information should be marked as such.

Required Business Information:

• UEI.
• Company Name.
• Company Address.
• Company Point of Contact, Phone and Email address
• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.
• Do you have a government-approved accounting system? If so, please identify the agency that approved the system.
• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html. This indication should be clearly marked on the first page of your Capability Statement (preferably placed under the eligible small business concern’s name and address).

Number of Copies:

Please submit one (1) electric copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Cindy Hargett, Contracting Officer, at cindy.hargett@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify reference number 75N98026R00169.

Common Cut-off Date

Electronically submitted tailored capability statements are due no later than 3:00 PM (Eastern Time) on September 30, 2026. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

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 to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities.

However, responses to this notice will not be considered adequate responses for a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).