Delivery Order 75F40119D10032-75F40120F19003

Award Date 9/29/20
Potential Completion Date 3/26/26
Potential Value $5.5M
Ultimate Awardee
Not listed
Federal Contract Vehicle
Set-Aside Type
No Set-Aside Used
Extent Competed
Full and Open Competition
Major Defense Program
Not listed
Pricing Type
Firm Fixed Price
Place of Performance
Silver Spring, MD 20993, USA
Solicitation Procedures
Negotiated Proposal / Quote
Number Of Offers Received
Not listed
Legislative Mandate
Not listed
National Interest Action
Not listed
Research Type
Not listed
Primary Consortia Member
Not listed
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  • 75F40119D10032
    Indefinite Delivery Contract
  • 75F40119D10032-75F40120F19003
    Delivery Order

This is a firm fixed price delivery order contract awarded by the U.S. Food and Drug Administration (FDA) to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business. The $5,454,071.53 contract is for the provision of clinical and laboratory applied regulatory science services to support the FDA's regulatory science programs and assist with regulatory decision-making across product lifecycles. The services include conducting clinical pharmacology studies, QT prolongation and electrocardiogram studies to evaluate cardiac safety, and providing regulatory process expertise. Spaulding Clinical Research performs this work at its facilities in West Bend, Wisconsin and Silver Spring, Maryland. This delivery order is part of a larger $30 million single award Indefinite Delivery Indefinite Quantity (IDIQ) contract the company holds with the FDA for clinical and laboratory applied regulatory science services, which was awarded in 2019 with a last ordering date of September 2024.

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