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Notice of Intent to Sole Source - Research Support Services

Awarded
NOI-CC-25-011573Federal

Contract Overview

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The National Institutes of Health Clinical Center intends to award a one-month emergency bridge order to Guidehouse Digital LLC to provide essential contract research and regulatory support services. This procurement, valued at not to exceed 250,000 dollars with a performance period ending September 30, 2025, is being conducted as a sole-source acquisition under FAR Part 13 Simplified Acquisition Procedures and FAR 6.302-2 due to unusual and compelling urgency. The services are critical for maintaining hospital facility operations, patient safety, and the integrity of clinical research and product manufacturing within the Office of Research Support and Compliance. The scope of work involves providing supplemental staffing for various roles, including Protocol Coordinators, Protocol Navigators, and Regulatory Affairs Specialists, to support the intramural clinical research community and aseptic processing facilities. Performance will take place at the NIH campus in Bethesda, Maryland, specifically within the Warren G. Magnuson Clinical Center, Mark O. Hatfield Clinical Research Center, and the Ambulatory Care Research Facility. The contractor must adhere to strict quality standards, including Joint Commission and OSHA requirements, and maintain high performance metrics such as a fill rate above 90 percent and a monthly turnover rate below 15 percent. Additionally, all personnel must undergo rigorous security vetting, including National Agency Checks with Inquiries and fingerprinting, to ensure compliance with federal privacy and security mandates.

General Info

NIH awards sole source one-month emergency contract to Guidehouse Digital for clinical research support.

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

2

PWS for Office of Research Support and Compliance Staffing Services

DOCX, High priority: read this firstsow
High

Sole Source Justification for Research Support Services NIH Clinical Center

DOCX, High priority: read this firstjustification-and-authorization
High

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Timeline

PhaseAwarded
Posted

special-notice

Awarded

Contract was awarded

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Office AddressBETHESDA, MD, 20892, USA
Contacts
Chris Ryssa Nix

Full Description

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This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested. National Institute of Health's Clinical Center intends to award a 1-month emergency bridge order to Guidehouse Digital LLC. This contract is to continue contract research support services to support hospital facility operations, patient safety, and clinical research. Scope of Work: The Clinical Center requires supplemental clinical research and regulatory support staffing to meet the needs of the intramural clinical research community and aseptic processing facilities. Contract providers will be assigned to work within the ORSC whose primary purpose is to ensure quality and integrity of clinical research and product manufacturing/compounding conducted at the NIH under the supervision of ORSC Chief in a biomedical research environment. Contractors may also be required to float to another section within their competency skill set within the office. ORSC support sections o include Clinical Research Management, Protocol Coordinators, Protocol Navigators, Investigational Drug/Device Regulatory and Research Regulatory Affairs Facilities support. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Ryssa Nix, Contract Specialist, by the close date below.

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