Indefinite Delivery Contract 75F40119D10032

The U.S. Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services, awarded a $30 million single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business, for-profit organization, and limited liability company. The IDIQ contract, awarded in 2019 with a last ordering date of September 2024, enables the FDA to issue task orders to Spaulding for clinical and laboratory applied regulatory science services. These services support the FDA's regulatory science programs and assist in regulatory decision-making across product lifecycles. Specific tasks include conducting clinical pharmacology studies, QT prolongation and electrocardiogram studies to evaluate cardiac safety, and providing regulatory process expertise. The work is performed at Spaulding's facilities in West Bend, Wisconsin and Silver Spring, Maryland, and the contract does not utilize any set-aside designations.

To date, the FDA has issued several firm fixed-price delivery orders under this IDIQ contract, ranging from $215,502 to $6.6 million in value, with periods of performance typically spanning 3-5 years. These delivery orders provide the FDA with a range of clinical and laboratory applied regulatory science services to support its mission of ensuring the safety and effectiveness of drugs, vaccines, biologics, and medical devices throughout their product lifecycles.