Delivery Order 75F40121D00014-75F40124F19011
- Not listed
- 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, 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 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 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 is a $601,333 delivery order contract awarded to Pinnacle 21, LLC by the Food and Drug Administration (FDA) for DataFit Systems operations and maintenance services. The contract is a labor-hour pricing type with a completion date of September 27, 2026. Pinnacle 21 is a for-profit limited liability company that specializes in software and services for clinical data quality, FDA submission readiness, and data systems support. This award is part of a larger $5 million Indefinite Delivery...
- 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 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 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...
- Pinnacle 21, LLC was awarded a $257,920 firm fixed price delivery order by the Department of Health and Human Services' Food and Drug Administration to provide automation of Study Data Tabulation Model - Analysis Data Model content validation services. The delivery order was issued against an existing indefinite delivery contract held by Pinnacle 21 with the FDA, valued at up to $5 million, to support ongoing data systems operations and maintenance. Under this delivery order, Pinnacle 21 will...
- 75F40121D00014Indefinite Delivery Contract
- 75F40121D00014-75F40124F19011Delivery Order
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 Model automation. This contract supports the FDA's regulatory review programs and ensures medical product safety. Pinnacle 21 has previously held contracts with the FDA to provide similar IT services. This contract has a period of performance ending on September 27, 2025 and does not have a set-aside designation.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $589.0k | 6/18/24 |