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
  • For Profit Organization
  • Limited Liability Company
Entity structure
Partnership or Limited Liability Partnership
NAICS codes registered in SAM.gov
Corporate family
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
  1. Health Care
  2. Pharmaceuticals, Biotechnology & Life Sciences
  3. 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

Pinnacle 21, LLC's 5 most recent federal contract and grant awards, newest first. Amounts are dollars obligated.
Award Agency Obligated Awarded
Datafit systems operations & maintenance services Contract · 75F40125F19013 Assistant Secretary for Financial Resources $601,333
FY25 cber study data validation task order - analysis data model (adam) content validation (casa-CV) Contract · 75F40125F19012 Assistant Secretary for Financial Resources $281,904
Cder datafit support services Contract · 75F40124F19011 Food and Drug Administration $589,021
FY24 cber automation of study data tabulation model (sdtm) - analysis data model (adam) content validation Contract · 75F40124F19010 Food and Drug Administration $208,125
Datafit support services Contract · 75F40123F19009 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

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