Certara Launches Pinnacle 21® Enterprise Plus to Deliver Regulatory Submissions Faster

Rhea-AI Summary

Certara (Nasdaq: CERT) has launched Pinnacle 21 Enterprise Plus, a new solution designed to streamline the creation and management of CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets for regulatory submissions. The platform features a no-code interface that delivers a 50% reduction in specification drafting time compared to traditional methods.

The solution addresses key challenges in data management by providing a unified workspace that improves collaboration and version control. Trusted by over 130 organizations globally, including the US FDA and Japan's PMDA, Pinnacle 21 Enterprise Plus offers configurable standards compliance, API integration with programming tools, and accelerated submission cycle times.

Positive

• Platform delivers 50% reduction in time spent drafting mapping specifications
• Solution is trusted by 130+ organizations including FDA and PMDA
• Implementation time is less than one month for most teams
• Seamless integration with programming tools like SAS and R through APIs

Negative

• None.

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Solution delivers a 50% reduction in time spent drafting mapping specifications, according to internal measurements

RADNOR, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical and statistical programmers to efficiently create, reuse, and manage required data specifications for creating the CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets. These datasets are required when sponsors present their study safety and efficacy results and analysis to regulators.

Traditional, spreadsheet-based methods of managing specifications are prone to errors, lack version control, and hinder collaboration. Pinnacle 21 Enterprise Plus directly addresses these challenges by offering a unified, collaborative workspace that accelerates the journey from source data to submission-ready datasets. The no-code interface is set to deliver a 50% reduction in time spent drafting mapping specifications, according to internal measurements.

“By expanding Pinnacle 21, we are investing in the future of data sciences,” said William F Feehery, Chief Executive Officer. “These innovations help shorten cycle times and accelerate regulatory submissions of new therapies for patients.”

Benefits of Pinnacle 21 Enterprise Plus:

• Support for industry and proprietary standards: Configurable columns ensure compliance with both CDISC and company-specific standards for maximum flexibility.
• Seamless Integration for programmers: The platform facilitates the export of mapping specifications via application programming interfaces (APIs) for seamless integration with downstream programming tools like SAS and R.
• Faster Submission Cycle Times: Earlier and easier creation of SDTM and ADaM mapping specifications provides submission-ready data sooner, mitigating end-of-study delays.
  

Pinnacle 21 Enterprise Plus is purpose-built for clinical and statistical programmers, the same professionals who rely on Pinnacle 21 Foundational Enterprise for critical data validation. Most teams can go live with Enterprise Plus in less than a month.

“This is an important milestone in realizing the Pinnacle 21 roadmap,” said Martin Snyder, President of Certara Data Sciences. “We are building a future-proof platform that delivers end-to-end data standardization and validation, while continually evolving to meet the needs of scientists and regulators.”

Certara's Pinnacle 21 solutions are trusted by more than 130 organizations globally, including leading biopharmaceutical companies and regulatory agencies like the US FDA and Japan's PMDA, solidifying Certara's position as a leader in clinical data standardization and validation.

For more information about Pinnacle 21 Enterprise Plus, please visit https://www.certara.com/pinnacle-21-enterprise-software/sdtm-specification-management/.

About Certara

Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.

Certara contact:

Sheila Rocchio
Sheila.rocchio@certara.com

Media contact:

Alyssa Horowitz
certara@pancomm.com

FAQ

What is Certara's new Pinnacle 21 Enterprise Plus software?

Pinnacle 21 Enterprise Plus is a platform that helps create and manage CDISC SDTM and ADaM datasets for regulatory submissions, featuring a no-code interface that reduces specification drafting time by 50%.

How much time does Pinnacle 21 Enterprise Plus save in mapping specifications?

According to Certara's internal measurements, Pinnacle 21 Enterprise Plus delivers a 50% reduction in time spent drafting mapping specifications compared to traditional methods.

How many organizations use Certara's Pinnacle 21 solutions?

Certara's Pinnacle 21 solutions are trusted by more than 130 organizations globally, including leading biopharmaceutical companies and regulatory agencies like the US FDA and Japan's PMDA.

How long does it take to implement Pinnacle 21 Enterprise Plus?

Most teams can implement and go live with Pinnacle 21 Enterprise Plus in less than one month.

What are the key benefits of Certara's Pinnacle 21 Enterprise Plus?

Key benefits include 50% faster specification drafting, support for industry and proprietary standards, seamless API integration with programming tools, and accelerated submission cycle times.