Spaulding Clinical Research, LLC

West Bend, WI

UEI
HERBKHMPKQN5
CAGE
6SNE2
Primary NAICS
541714 Research and Development in Biotechnology (except Nanobiotechnology)
SAM.gov registration
Active through

Company facts

Self-certified in SAM.gov
  • For Profit Organization
  • Limited Liability Company
Entity structure
Partnership or Limited Liability Partnership
NAICS codes registered in SAM.gov
SAM.gov registration date
Physical address
525 S Silverbrook Dr, West Bend, WI 53095, USA
Website
spauldingclinical.com
Founded
2007
Employees
51-250
Estimated annual revenue
$10M-$50M
Industry
  1. Industrials
  2. Commercial & Professional Services
  3. Professional Services
  4. Research & Consulting Services
SIC code
87 Engineering & Management Services
Profiles

Registration and certifications come from SAM.gov and the SBA; company details from public web sources. Updated .

Recent federal awards

Spaulding Clinical Research, LLC's 5 most recent federal contract and grant awards, newest first. Amounts are dollars obligated.
Award Agency Obligated Awarded
Clinical pharmacology studies Contract · 75F40123F19005 Food and Drug Administration $6,000,321
Office of clinical pharmacology - new task order #4 against spaulding clinical studies IDIQ 75F40119D10032 - clinical… Contract · 75F40121F19004 Food and Drug Administration $1,429,138
Clinical and laboratory applied regulatory science Contract · 75F40120F19003 Food and Drug Administration $5,454,072
Clinical and laboratory applied regulatory science Contract · 75F40120F19002 Food and Drug Administration $215,502
Clinical and laboratory applied regulatory science Contract · 75F40119F19001 Food and Drug Administration $6,561,387

About Spaulding Clinical Research, LLC

Spaulding Clinical Research, LLC is a full-service Phase I clinical pharmacology unit, cardiac core lab, and medical device manufacturer that specializes in IND enabling clinical pharmacology studies, cardiovascular safety, and clinical proof of concept. Spaulding Clinical is registered in SAM.gov as a self-certified small disadvantaged business, for-profit organization, and limited liability company.

Over the past several years, Spaulding Clinical Research has been awarded numerous firm fixed price delivery orders from the Department of Health and Human Services' Food and Drug Administration (FDA) to provide a range of 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 performed include conducting clinical pharmacology studies, QT prolongation and electrocardiogram studies to evaluate cardiac safety, and providing regulatory process expertise. The delivery orders range from around $200,000 to over $5 million in value, with periods of performance typically spanning 3-5 years. Spaulding Clinical Research performs this work at its facilities in West Bend, Wisconsin and Silver Spring, Maryland with no major subcontractors identified.

Spaulding Clinical Research holds a $30 million single award Indefinite Delivery Indefinite Quantity (IDIQ) contract from HHS FDA for clinical and laboratory applied regulatory science services. Awarded in 2019 with a last ordering date of September 2024, this IDIQ allows FDA to issue task orders to Spaulding in support of the agency's mission to ensure the safety and effectiveness of drugs, vaccines, biologics and medical devices. Task areas likely include clinical studies, laboratory testing, regulatory consulting and other services that leverage Spaulding's clinical research and regulatory process expertise throughout a product's lifecycle.

Quick answers

What is Spaulding Clinical Research, LLC's UEI?

Spaulding Clinical Research, LLC's Unique Entity ID (UEI) in SAM.gov is HERBKHMPKQN5.

What is Spaulding Clinical Research, LLC's CAGE code?

Spaulding Clinical Research, LLC's CAGE code is 6SNE2.

What is Spaulding Clinical Research, LLC's primary NAICS code?

Spaulding Clinical Research, LLC's primary NAICS code is 541714 (Research and Development in Biotechnology (except Nanobiotechnology)).

Where is Spaulding Clinical Research, LLC located?

Spaulding Clinical Research, LLC's physical address in SAM.gov is 525 S Silverbrook Dr, West Bend, WI 53095, USA.

Is Spaulding Clinical Research, LLC registered in SAM.gov?

Yes. Spaulding Clinical Research, LLC's SAM.gov registration is active through May 4, 2027.

What is Spaulding Clinical Research, LLC's most recent federal award?

Spaulding Clinical Research, LLC's most recent federal contract award is Clinical pharmacology studies (75F40123F19005), from Food and Drug Administration, on September 28, 2023.

On GovTribe

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