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Clinical Research Operations & Management Support (CROMS)   4

ID: 75N93022R00040 • Type: Sources Sought • Match:  85%
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Description

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad 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, including research to counter bioterrorism. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts.

The evaluation of therapeutics, vaccines, devices, diagnostics and treatment strategies in clinical trials and studies is an essential element of the efforts of NIAID. Through multiple grant and contract research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 1-4 clinical trials; surveillance or natural history / cohort studies; evaluation of novel diagnostic devices or product delivery systems; new vaccine formulations, schedules and modes of delivery; evaluation of safety and efficacy of vaccines and therapeutics against emerging infectious diseases, including NIAID Category A, B and C priority pathogens; and studies of critical public health needs for emerging and re-emerging infectious diseases. The NIAID DMID Office of Clinical Research Affairs (OCRA) provides resources and services in support of clinical research to DMID and DMID-supported investigators and fulfills DMID's regulatory obligations for clinical research oversight through a contract for clinical research operations and management support services: Clinical Research Operations and Management Support (CROMS).

Background
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) under the Department of Health and Human Services (DHHS), focuses on understanding, treating, and preventing infectious, immunologic, and allergic diseases.

The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research aimed at controlling diseases caused by infectious agents, including bioterrorism. This involves both basic and applied research to develop therapeutics, vaccines, and diagnostics. The NIAID DMID Office of Clinical Research Affairs (OCRA) provides essential resources for clinical research oversight through a contract for Clinical Research Operations and Management Support (CROMS).

Work Details
Contractors will support DMID and clinical sites with various tasks including: risk assessment and mitigation; site monitoring; safety monitoring/pharmacovigilance; safety oversight committees; human subjects protection; regulatory document management; quality management; training; medical writing; data systems and analytics.

Specific requirements include: safety monitoring with proposed reporting systems for serious adverse events (SAEs); planning and conducting clinical site monitoring; conducting pre-study activities including assessments; providing medical writing services for clinical protocols; maintaining a centralized data system for tracking protocol information; managing data analytics; developing quality assurance plans; implementing training programs for clinical site personnel; and expanding staffing as needed during the contract period. Contractors must also be prepared to support approximately 200 active clinical trials at the start of the contract, with an anticipated 45 new trials initiated each year.

Period of Performance
The anticipated duration is one year with options for six additional years.

Place of Performance
The specific place of performance is currently unknown but may include both domestic and foreign locales.
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Overview

Agency
National Institutes of Health (NIH) [HHS]
Response Deadline
Dec. 2, 2022, 2:00 p.m. EST Past Due
Posted
Nov. 17, 2022, 3:08 p.m. EST
Set Aside
None
NAICS
541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
PSC
AN12 - Health R&D Services; Health Care Services; Applied Research
Place of Performance
USA
Source
Open
Current SBA Size Standard
1000 Employees
Pricing
Likely Fixed Price
Odds of Award
39%
On 11/17/22 National Institutes of Health issued Sources Sought 75N93022R00040 for Clinical Research Operations & Management Support (CROMS) due 12/2/22. The opportunity was issued full & open with NAICS 541715 and PSC AN12.
Primary Contact
Name
Michael P. Welsh   Profile
Email
welshmi@mail.nih.gov
Phone
(240) 669-5132

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > NATIONAL INSTITUTES OF HEALTH > NATIONAL INSTITUTES OF HEALTH NIAID
FPDS Organization Code
7529-00310
Source Organization Code
100188096
Last Updated
Dec. 17, 2022
Last Updated By
welshmi@mail.nih.gov
Archive Date
Dec. 18, 2022