This is a delivery order contract awarded to Pinnacle 21, LLC by the Department of Health and Human Services Food and Drug Administration (HHS FDA). The contract supports operations and maintenance of data systems that enable the FDA's regulatory review programs and ensure medical product safety. The services include data validation, automation of content validation, data systems support, data management, and validation of CDISC data models. The contract has a potential value of $573,049.62...
This federal contract was awarded by the Department of Health and Human Services' Food and Drug Administration (HHS FDA) to Pinnacle 21, LLC, a for-profit limited liability company. The $213,872.73 contract is for Pinnacle 21 to provide data validation, automation, systems support, data management, and other IT services to maintain the functionality of FDA data systems used in regulatory review and medical product safety programs. This is a delivery order under a larger $5 million indefinite...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $737,224 delivery order contract to Pinnacle 21, LLC for datafit support services. Under this contract, Pinnacle 21 will provide data management and analytics support to assist HHS FDA programs in Silver Spring, Maryland. No subcontractors or set aside designations were identified. This delivery order was issued against an unspecified governmentwide acquisition contract vehicle and will cover services...
This federal contract award to Pinnacle 21, LLC provides Data Fit Systems Operations and Maintenance Support Services to the U.S. Food and Drug Administration (FDA), an agency of the Department of Health and Human Services (HHS). The $488,404.58 contract has a period of performance through September 27, 2017 and was awarded on a labor hours pricing basis without any set-aside designation. Pinnacle 21 has previously held other contracts to provide IT services in support of FDA data systems and...
This federal contract award to Pinnacle 21, LLC is for operations and maintenance support services for the Department of Health and Human Services' Food and Drug Administration (HHS FDA). The contract has a potential value of $493,313.62 and is a labor hour delivery order with no set aside designation. Pinnacle 21, a limited liability company, has provided a range of IT services to support data systems operations, maintenance, and analytics for the FDA's regulatory review programs to help ensure...
This federal contract award was issued by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services (HHS), to Pinnacle 21, LLC, a prime contractor. The $224,810 firm fixed price delivery order is for the "Automation of Study Data Tabulation Model (SDTM) - Analysis Data Model (ADAM) Content Validation (CASA-CV)." This work supports the FDA's regulatory review programs and ensures medical product safety by maintaining and enhancing...
This is a firm fixed price delivery order awarded by the Department of Health and Human Services' Food and Drug Administration (HHS FDA) to Pinnacle 21, LLC, a limited liability company that provides software and services for managing CDISC compliance, clinical data quality, and FDA submission readiness. The $154,757.28 contract is for the automation of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADAM) content validation, which supports the FDA's regulatory review programs and...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $649,837 Delivery Order contract to Pinnacle 21, LLC of Penllyn, Pennsylvania to provide DataFit Systems Operations and Maintenance Support Services from September 7, 2022 through September 27, 2023. Pinnacle 21, LLC will be responsible for providing operations and maintenance support services for the FDA's DataFit Systems under a labor-hours pricing arrangement over the one-year base period of...
Pinnacle 21, LLC was awarded a $223,540 delivery order against its indefinite delivery contract with the Department of Health and Human Services' Food and Drug Administration to provide Automation of Study Data Tabulation Model (SDTM) - Analysis Data Model (ADAM) Content Validation (CASA-CV) services. The prime contractor will perform the work in Penllyn, Pennsylvania through September 2022, utilizing a labor hour pricing structure. Pinnacle 21 is an industry leader in CDISC compliance and...
This federal contract award, with an ID of 75F40121D00014|75F40124F19010, was granted by the Food and Drug Administration (FDA) to Pinnacle 21, LLC, a for-profit limited liability company based in Blue Bell, Pennsylvania. The contract, which does not have a set-aside designation, is for the Fiscal Year 2024 automation of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADAM) content validation services in support of the FDA's Center for Biologics Evaluation and Research (CBER). The...