This federal contract award was issued by the Food and Drug Administration (FDA) to Pinnacle 21, LLC, a for-profit limited liability company located in Blue Bell, Pennsylvania. The $649,153 delivery order contract is for "DATAFIT SUPPORT SERVICES" and has a period of performance through September 12, 2025. The contract is a labor-hour type with no set-aside designation. Pinnacle 21 is the prime contractor and has held a $5,000,000 Indefinite Delivery Contract (IDC) with the FDA since...
This federal contract award to Pinnacle 21, LLC is for DATAFIT SUPPORT SERVICES to be provided to the Department of Health and Human Services' Food and Drug Administration (HHS FDA). The contract has a potential value of $139,493.86 and is a Delivery Order with a Time and Materials pricing type. The services to be delivered under this contract include data validation, automation of content validation, data systems support, data management, Standardized Data Tabulation Model - Analysis Data Model...
This federal contract award, valued at $589,021.00, was issued by the Food and Drug Administration (FDA) to Pinnacle 21, LLC, a prime contractor. The contract provides Data Fit Support Services to the Center for Drug Evaluation and Research (CDER) at the FDA. The services include data validation, automation of content validation, data systems support, data management, Standardized Data Tabulation Model - Analysis Data Model content validation, and Study Data Tabulation Model - Analysis Data...
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...
This 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 $114,702.08 delivery order contract is for Pinnacle 21 to provide data systems operations, maintenance, and analytics support services to the FDA. The services aim to maintain functionality of systems that enable the FDA's regulatory review programs and ensure medical product safety. This delivery order is part of a...
This is a $281,904 firm-fixed-price delivery order awarded by the Food and Drug Administration (FDA) to Pinnacle 21, LLC, a for-profit limited liability company based in Blue Bell, Pennsylvania. The order is for analysis data model (ADAM) content validation services under the FY25 CBER STUDY DATA VALIDATION TASK ORDER (CASA-CV) program. The order has a completion date of September 17, 2026. Pinnacle 21 holds a $5,000,000 indefinite delivery contract (IDC) with the FDA for DataFit Systems...
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...
This is a federal delivery order awarded by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the Department of Health and Human Services (HHS), to Pinnacle 21, LLC, a small business that specializes in software and services for managing clinical data quality and FDA submission readiness. The $10,600 firm-fixed-price delivery order is for Pinnacle 21's Pinnacle 21 Enterprise single sign-on software and support. This delivery order is part of a larger Multiple...
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...