Early Phase Clinical Trial Units (EPCTU)

Closed Pre-Solicitation Posted

This opportunity was awarded. See its 5 award notices in the notice history.

Solicitation number
RFP-NIAID-NIH-AI-75N93020R00023
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

This pre-solicitation notice seeks multiple Indefinite Delivery/Indefinite Quantity contracts to support Phase 0 through Phase II clinical trials of investigational products against infectious diseases through the National Institute of Allergy and Infectious Diseases. Contractors will collaborate with monitoring and data management partners to conduct domestic and international trials efficiently under a January 2022 anticipated award date and seven-year ordering period. Eligible offerors may submit proposals via the NIH electronic submission system for consideration to support the full range of early phase clinical trial activities, including administrative support, Phase 0 healthy volunteer studies, Phase I healthy volunteer studies, Phase I special population studies, and Phase II or III patient studies.

There is no set-aside designation. The main NAICS codes are 541715 and 541712, with PSC codes R425 and R499. No potential incumbents or current contractors are named. The pre-solicitation notice does not provide possible award values or budget ranges. Contractors will support Phase 0 through Phase III clinical trials of investigational infectious disease products over a seven-year ordering period beginning in January 2022.

Notice text

The purpose of the anticipated solicitation is to implement Phase 0 to Phase II clinical trials, including proof-of-concept studies in healthy and diseased human populations—domestically and internationally—in an expeditious and efficient manner, aided by bioanalysis when necessary.  Additionally, in the event of urgent public health need, Phase III studies may be conducted. The candidate products to be evaluated under the Early Phase Clinical Trial Units (EPCTU) IDIQ contracts could include new or tested investigational products, such as small  molecules; monoclonal antibodies; immunoglobulins; convalescent plasma; passive transfer studies; vaccines; adjuvants; and other immunomodulatory products against infectious diseases, arising within DMID’s preclinical and early product development programs, as well as those arising from other research partners outside of DMID.

Files

File Type Posted
EPCTU Presolicitation Notice.pdf PDF

Notice history

Notice Type Posted
Early Phase Clinical Trial Units (EPCTU) Latest Award Notice
Early Phase Clinical Trial Units (EPCTU) Award Notice
Early Phase Clinical Trial Units (EPCTU) Award Notice
Early Phase Clinical Trial Units (EPCTU) Latest solicitation Solicitation
This notice Original Pre-Solicitation

5 of 7 notices listed here. See the rest on GovTribe.

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