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
- Other NAICS codes in SAM.gov
- Corporate family
-
-
Parent
Radnor, PA
HWLYE4KDVHB6
-
Parent
Radnor, PA
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
-
- 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 .
Contract obligations by fiscal year
| Fiscal year | Obligated |
|---|---|
| FY2027 To date | $0 |
| FY2026 | -$67,155 |
| FY2025 | $883,237 |
| FY2024 | $1,153,046 |
| FY2023 | $1,284,218 |
Contract vehicles
Contract awards
Latest 5 listed here. See the rest on GovTribe.
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About the company
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.
Quick answers
Is Pinnacle 21, LLC registered in SAM.gov?
Yes. Pinnacle 21, LLC's SAM.gov registration is active through March 9, 2027.
Which contract vehicles does Pinnacle 21, LLC hold?
Pinnacle 21, LLC holds a place on 2 federal contract vehicles, including IT-70 and MAS.
How much has Pinnacle 21, LLC received in federal contracts?
Federal contracts obligated $883,237 to Pinnacle 21, LLC in fiscal year 2025 and $3,253,346 in fiscal years 2023 through 2027.
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
- Similar vendors