Request for Information (RFI): Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID)
Closed Pre-Solicitation Posted
- Solicitation number
- NIH-NIAID-RFI-001-26
- Agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- R702 Support- Management: Data Collection
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), is issuing a Request for Information on a Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID), with responses due July 8, 2026. This RFI is issued solely for information and planning purposes under FAR 15.101(c); responses will not be returned and the Government will not reimburse response costs or obligate itself to award a contract.
The anticipated SDCC contract will support NIAID's clinical research portfolio spanning Phase 0–4 therapeutics and vaccine trials, surveillance and cohort studies, diagnostic evaluations, and repurposing trials for infectious diseases. The portfolio encompasses primarily domestic clinical sites with capability to support international studies. NIAID requires the SDCC to maintain FDA regulatory compliance and standardized deliverables including safety oversight and monitoring.
The RFI solicits feedback across eleven functional areas: AI tool incorporation with data confidentiality safeguards; 21 CFR Part 11–compliant data collection and management for large multi-site portfolios; 100 percent data verification for audit readiness; protocol and materials preparation; web-based communication and collaboration; statistical design and analysis including emerging methodologies and omics analysis; 24/7 clinical site training and technical support; electronic specimen tracking; secure data storage with occasional access; de-identification and data sharing for NIH and NIAID repositories; and centralized project management.
Respondents must provide organizational overview, relevant experience managing comparable data coordinating centers, technical capabilities, international experience, and teaming information. Responses are limited to ten pages (excluding cover page and organizational information) in PDF format, submitted to miranda.adams@nih.gov. All non-proprietary information becomes Government property for acquisition planning.
Notice text
THIS IS A REQUEST FOR INFORMATION (RFI) ONLY
In accordance with RFO 15.101(c), this RFI is issued solely for information and planning purposes. It does not constitute a solicitation for proposals, quotations, or abstracts, nor does it obligate the Government to award a contract or pay for any information provided. Responses will not be returned. No reimbursement will be made for costs associated with responding to this notice.
1. 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 infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, an essential component of U.S. efforts to ensure the health and safety of the American people. Through multiple grant- and contract-funded research programs, NIAID supports a broad range of clinical research, including single-site and multi-center trials spanning Phase 0-4 therapeutics and vaccines, new vaccine formulations, schedules, and modes of delivery; surveillance or natural history / cohort studies for pathogens of interest; evaluation of novel diagnostics; and clinical trials designed to find additional uses for already approved therapies for selected infectious diseases. The portfolio includes primarily domestic clinical sites, with the ability to support international studies.
As part of clinical research portfolio, NIAID has regulatory obligations for clinical trials that include standardized deliverables, reporting, safety oversight, and monitoring. NIAID therefore requires resources to support its clinical research activities in compliance with regulatory requirements. One of those resources is a Statistical and Data Coordinating Center (SDCC) which provides centralized data management, statistical, and specimen tracking services essential to this clinical research portfolio. NIAID is exploring the re-competition of its Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID) contract.
2. Purpose
The Government is issuing this RFI to:
- Facilitate early engagement with industry prior to release of a formal Request for Proposals (RFP), in accordance with RFO 15.101(c).
- Assess current market capabilities and vendor offerings relevant to SDCC services.
- Gather input on industry best practices to inform development of a future Statement of Work (SOW).
- Support fair and open competition in accordance with FAR 5.401.
Full RFI Attached.
Files
| File | Type | Posted |
|---|---|---|
| SDCC_RFI_NIAID_26.pdf |
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| Pre-Clinical Models of Infectious Diseases | National Institute of Allergy and Infectious Diseases | No set-aside | |
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