NIAID Solicitation Invites Proposals for Early-Phase Clinical Trial Units

Funding News Edition: January 21, 2021
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Through the new request for proposals (RFP) Early-Phase Clinical Trial Units (EPCTU), NIAID seeks offerors capable of implementing 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.

The candidate products evaluated under the EPCTU contracts may 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 NIAID’s Division of Microbiology and Infectious Diseases (DMID) preclinical and early product development programs, as well as those originating from other research partners outside of DMID.

NIAID may also leverage EPCTU contracts to conduct Phase III clinical trials in the event of an urgent public health need.

Task Areas

NIAID anticipates awarding indefinite delivery/indefinite quantity type contracts to multiple contractors qualified to support a full range of activities in the following task areas:

  • Administrative and Overall Clinical Operations Support and Concept Development (Task Area A)
  • Phase 0 Healthy Subject Studies (Task Area B)
  • Phase I Healthy Subject Studies (Task Area C)
  • Phase I Special Populations (Task Area D)
  • Phase II or III Disease Subject Studies (Task Area E)

Contractors should employ qualified clinical staff with expertise in carrying out all aspects of interventional clinical trials, including bioanalysis. Further, contractors will collaborate with companies under contract to NIAID that provide clinical site monitoring, regulatory support, safety oversight, and data management and analysis.

Key Details

Awards made from this solicitation will be multiple-year cost-reimbursement type completion contracts with a seven-year ordering period and a period of performance from January 14, 2022, to January 13, 2032.

NIAID will evaluate cost/price proposals for reasonableness, although it is not a technical evaluation criterion.

Proposals are due February 26, 2021, by 2 p.m. Eastern Time. Submit your proposal online through NIH’s electronic Contract Proposal Submission (eCPS) site.

Contact Michael Welsh, the solicitation’s contracting officer, with any questions about the RFP.

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