Early Phase Clinical Trial Units (EPCTU)

Award Date 1/14/2022
Last Date To Order 1/13/2032
Shared Ceiling $347M
Contract Type
Master IDIQ
Predecessor
Not listed
Successors

The Early Phase Clinical Trial Units (EPCTU) Indefinite Delivery/Indefinite Quantity (IDIQ) contract, awarded by the National Institute of Allergy and Infectious Diseases (NIAID), is designed to support the implementation of early-stage clinical trials for investigational products targeting infectious diseases. The contract facilitates Phase 0 to Phase II clinical trials, with potential for Phase III studies during urgent public health scenarios. Candidate products include small molecules, monoclonal antibodies, immunoglobulins, convalescent plasma, vaccines, adjuvants, and other immunomodulatory products arising from NIAID's preclinical development programs or external research partners.

The EPCTU IDIQ has awarded multiple task orders to prominent clinical research organizations, with typical contract values ranging from approximately $1.5 million to $3.2 million and performance periods extending to January 2032. Prime contractors include Allucent Government Services, Icon Government and Public Health Solutions, PPD Development LP, Dynport Vaccine Company LLC, and Duke University. All task orders to date have been Cost Plus Fixed Fee delivery orders without set-aside designations, primarily supporting clinical trial planning, execution, site monitoring, and regulatory management. The contracts predominantly involve work performed domestically, with NIAID as the primary funding agency. The contract's broad scope allows for flexible, expeditious clinical trial support across various stages of infectious disease product development.

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