Pinnacle 21
Pinnacle 21 is a clinical data standardization software platform serving pharmaceutical, biotechnology, and CRO customers, validating and harmonizing trial data against CDISC standards for FDA, PMDA, and NMPA regulatory submissions.
- Company typePrivate
- Founded2011
- HeadquartersPlymouth Meeting, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Pinnacle 21 does
Pinnacle 21 is a clinical data standardization software platform, originally founded in 2011 and currently operating as a product line under Certara (NASDAQ: CERT). The platform enables pharmaceutical, biotechnology, and Contract Research Organization (CRO) customers to validate, standardize, and harmonize clinical trial data against CDISC data standards (SDTM, ADaM, SEND) and global regulatory requirements from agencies including the FDA, PMDA, and NMPA. Its modular Enterprise platform comprises nine add-on modules covering real-time validation, Clinical Metadata Repository (CMDR), trial design automation, define.xml generation, study data reviewer's guide (SDRG/ADRG) creation, SDTM/ADaM mapping specification management, CRF creation with EDC visualization for Medidata Rave and Veeva Vault, issue management, and external vendor data exchange. The company reports 19,000+ users, 17 years of CDISC compliance leadership, and an 80% reduction in effort when creating define.xml files.
The go-to-market combines a freemium "Pinnacle 21 Community" tier, offering free Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner tools, with paid Enterprise and Enterprise Plus subscription tiers sold via direct enterprise field sales. Revenue is generated through annual subscription licenses and professional services/technical support, with pricing quoted rather than publicly disclosed. The customer base includes large pharma, mid-stage biotech transitioning from Phase II to Phase III, and CROs that require standardized, submission-ready deliverables. The platform is sold to clinical data management teams, statistical programming groups, and regulatory affairs functions within sponsor organizations. Pinnacle 21 is ISO 27001 certified at the Certara level, holds deep integrations with major EDC platforms, and benefits from Certara's distribution footprint of 30+ countries and 1,550+ employees.
Pinnacle 21 firmographics
Firmographics- Name
- Pinnacle 21
- Legal name
- Certara USA, Inc.
- Website
- https://pinnacle21.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Pinnacle 21 is a clinical data standardization software platform serving pharmaceutical, biotechnology, and CRO customers, validating and harmonizing trial data against CDISC standards for FDA, PMDA, and NMPA regulatory submissions.
- Ownership category
- akta.pro rank
Pinnacle 21 industry classification
Industry- Product category
- Clinical Data Standardization Software
- NAICS
- Scientific Research and Development Services (5417)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Data Management, Reporting & Regulatory Submissions for Central Labs (HLAGAEAL)
Keywords
Where Pinnacle 21 is headquartered
LocationHeadquarters
- HQ city
- Plymouth Meeting
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Pinnacle 21 business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure
Revenue model
- Enterprise Software Licenses (Subscription): Pinnacle 21 Enterprise software suite with modular add-ons including Trial Design, Issue Management, Validation, Define.xml, Reviewer's Guide, Mapping Specs, CRF Creator, Data Exchange, and MDR modules. Sold as platform licenses to pharmaceutical companies, biotech firms, and CROs.
- Professional Services - Technical Support: Technical support services combining clinical data standards expertise with decades of experience helping clients achieve regulatory compliance and expedited submissions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Freemium | Others | Pinnacle 21 Community - Free version |
| Subscription | Annual | Pinnacle 21 Enterprise |
| Subscription | Annual | Pinnacle 21 Enterprise Plus |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels10 records
Pinnacle 21 product offering
Product offeringCore offering
Pinnacle 21 provides clinical data standardization software used by pharmaceutical, biotech, and contract research organizations to validate, harmonize, and prepare clinical trial datasets for regulatory submissions to agencies such as the FDA, PMDA, NMPA, and MHRA. The platform ensures CDISC compliance and produces submission-ready artifacts including define.xml, Reviewer's Guides, and annotated CRFs. It is sold as an enterprise platform with modular add-ons and an adjacent free Community edition for individual users.
Product overview
Pinnacle 21 is a clinical data standardization platform offered as Pinnacle 21 Enterprise with modular add-ons. The core platform provides clinical data validation, metadata management, and submission readiness capabilities. The Enterprise Suite includes nine modules: Trial Design (auto-fill/validate trial design datasets), Issue Management (in-stream issue resolution), Validation (automated CDISC validation), Define.xml (automated define file creation), Reviewer's Guide (SDRG/ADRG generation), Mapping Specs (SDTM/ADaM specification automation), CRF Creator (EDC visualization for Rave/Veeva), External Data Exchange (vendor data workflows), and Clinical Metadata Repository (standards governance). Pinnacle 21 Community provides free basic validation tools. All modules align with CDISC data standards for FDA, PMDA, and NMPA regulatory submissions.
Differentiator
Problem solved
Functional benefit
Brands
- Pinnacle 21 Community: Free community version of Pinnacle 21 offering basic validation capabilities, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner.
- Pinnacle 21 Enterprise
- Pinnacle 21 Enterprise Plus
Products and services
- Pinnacle 21 Enterprise
- Pinnacle 21 Community
- Issue Management Module
- Trial Design Module
- Validation Module
- Define.xml Module
- Reviewer's Guide Module
- Mapping Specs Module
- CRF Creator Module
- External Data Exchange Module
- Clinical Metadata Repository (CMDR) Module
Quantifiable outcome
- 80% reduction in effort when creating define.xml files
- +2 more outcomes
Companies that use Pinnacle 21
Customer profileNamed customers3 records
Segments6 records
Ideal customer profiles3 records
Pinnacle 21 technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
Feature9 records
Pinnacle 21 partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- BiogencoreBiogen partnered with Certara to transform study metadata management using Pinnacle 21's Metadata Repository. This collaboration drove operational excellence by pairing study metadata management with CDISC standards, transforming clinical trial processes.
- MerckcoreCertara announced expansion of clinical technology collaboration with Merck, enhancing clinical data standardization and validation capabilities for Merck's drug development programs.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
Pinnacle 21 competitors and assessment
Company assessmentMarket position
Competitive moat6 records
Key risks5 records
Key highlights7 records
Customer concentration
Pinnacle 21 social profiles
Digital presencePinnacle 21 compliance and trust
Trust signalCompliance1 record
Pinnacle 21 financial estimates
Financial estimateRevenue estimate
Valuation estimate
Pinnacle 21 leadership team
Management profileNumber of profiles
Profiles2 records
Pinnacle 21 funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Pinnacle 21 M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Pinnacle 21
What does Pinnacle 21 do?
Pinnacle 21 provides clinical data standardization software used by pharmaceutical, biotech, and contract research organizations to validate, harmonize, and prepare clinical trial datasets for regulatory submissions to agencies such as the FDA, PMDA, NMPA, and MHRA. The platform ensures CDISC compliance and produces submission-ready artifacts including define.xml, Reviewer's Guides, and annotated CRFs. It is sold as an enterprise platform with modular add-ons and an adjacent free Community edition for individual users.
Is Pinnacle 21 a public or private company?
Pinnacle 21 is a private company. It is classified as public and is currently operating.
When was Pinnacle 21 founded?
Pinnacle 21 was founded in 2011. It employs 11 to 50 people.
Where is Pinnacle 21 based?
Pinnacle 21 is headquartered in Plymouth Meeting, United States, in the North America region.
How does Pinnacle 21 make money?
Two revenue lines are on record. Enterprise Software Licenses (Subscription) is the primary driver. The others are professional Services - Technical Support.
Does Pinnacle 21 have an API?
No public API is recorded for Pinnacle 21.
What industry is Pinnacle 21 in?
Pinnacle 21's product category is Clinical Data Standardization Software. Its primary akta.pro industry code is HLAGAEAL, Data Management, Reporting & Regulatory Submissions for Central Labs. Its NAICS code is 5417 and its SIC code is 7372.