Pinnacle 21, LLC
Blue Bell, PA Part of Certara USA Inc.
- UEI
- VB5LDF5AU489
- CAGE
- 73GB6
- Primary NAICS
- 513210 Software Publishers
- SAM.gov registration
- Active through
Company facts
- Self-certified in SAM.gov
- Entity structure
- Partnership or Limited Liability Partnership
- NAICS codes registered in SAM.gov
- Corporate family
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-
Certara USA Inc.
Parent
HWLYE4KDVHB6
- Pinnacle 21, LLC VB5LDF5AU489
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Certara USA Inc.
Parent
HWLYE4KDVHB6
- SAM.gov registration date
- Physical address
- 1777 Sentry Pkwy W #405, Blue Bell, PA 19422, USA
- Website
- certara.com
- Founded
- 2008
- Employees
- 1K-5K
- Industry
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- Health Care
- Pharmaceuticals, Biotechnology & Life Sciences
- Biotechnology
- 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
| Award | Agency | Obligated | Awarded |
|---|---|---|---|
| Datafit systems operations & maintenance services | Assistant Secretary for Financial Resources | $601,333 | |
| FY25 cber study data validation task order - analysis data model (adam) content validation (casa-CV) | Assistant Secretary for Financial Resources | $281,904 | |
| Cder datafit support services | Food and Drug Administration | $589,021 | |
| FY24 cber automation of study data tabulation model (sdtm) - analysis data model (adam) content validation | Food and Drug Administration | $208,125 | |
| Datafit support services | Food and Drug Administration | $649,153 |
About Pinnacle 21, LLC
Pinnacle 21, LLC is a for-profit limited liability company located in Blue Bell, Pennsylvania, specializing in software and services for clinical data quality, FDA submission readiness, and data systems support. The company provides critical technology solutions primarily to federal health agencies, with a focus on clinical data management and regulatory compliance domains. Pinnacle 21 offers cloud-based applications like OpenCDISC Enterprise, which are used by agencies such as the Food and Drug Administration (FDA) to review and validate medical product submissions.
The company has consistently provided data validation, content validation automation, data systems support, and data management services across multiple federal agencies. Most of Pinnacle 21's prime contract work has been with the FDA, specifically supporting centers like the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Their contracts involve automating Study Data Tabulation Model (SDTM) and Analysis Data Model (ADAM) content validation, maintaining regulatory review systems, and ensuring medical product safety. The majority of their contracts are not set-aside, indicating open competition. Pinnacle 21 frequently collaborates with International Business Machines Corporation (IBM) as a subcontractor, with multiple sub-awards for computer programming services.
Pinnacle 21, LLC holds a significant Indefinite Delivery Contract (IDC) with the FDA, awarded on May 18, 2021, with a potential value of $5,000,000. This single-award contract supports DataFit Systems operations and maintenance support services, with a performance period through May 2026. The contract has generated multiple delivery orders ranging from $223,540 to $696,589, covering various data systems operations, maintenance, and validation services. Additionally, the company has secured delivery orders under Multiple Award Schedule (MAS) contracts, including one with the National Institute of Allergy and Infectious Diseases (NIAID) for software and support services. These contract vehicles demonstrate Pinnacle 21's strategic positioning as a key technology partner for federal health agencies, particularly in supporting critical data systems used for clinical trial data validation and analysis.
Contract vehicles
Quick answers
What is Pinnacle 21, LLC's UEI?
Pinnacle 21, LLC's Unique Entity ID (UEI) in SAM.gov is VB5LDF5AU489.
What is Pinnacle 21, LLC's CAGE code?
Pinnacle 21, LLC's CAGE code is 73GB6.
What is Pinnacle 21, LLC's primary NAICS code?
Pinnacle 21, LLC's primary NAICS code is 513210 (Software Publishers).
Where is Pinnacle 21, LLC located?
Pinnacle 21, LLC's physical address in SAM.gov is 1777 Sentry Pkwy W #405, Blue Bell, PA 19422, USA.
Is Pinnacle 21, LLC registered in SAM.gov?
Yes. Pinnacle 21, LLC's SAM.gov registration is active through March 9, 2027.
Who is Pinnacle 21, LLC's parent company?
Pinnacle 21, LLC is part of Certara USA Inc.
Which contract vehicles does Pinnacle 21, LLC hold?
Pinnacle 21, LLC holds a place on 2 federal contract vehicles, including IT-70 and MAS.
What is Pinnacle 21, LLC's most recent federal award?
Pinnacle 21, LLC's most recent federal contract award is Datafit systems operations & maintenance services (75F40125F19013), from Assistant Secretary for Financial Resources, on September 10, 2025.
On GovTribe
See Pinnacle 21, LLC's full federal record
- Federal contract awards
- IDV awards
- Contract vehicles
- Funding analysis by agency, NAICS and set-aside
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