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Certara Introduces Update of Pinnacle 21™ Enterprise and New Pinnacle 21™ Data Exchange Module

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Certara, Inc. recently announced the release of Pinnacle 21 Enterprise version 5.2.0, enhancing biosimulation software for validating clinical trial data. This update includes new analytics features to ensure compliance with FDA regulations, improved team collaboration tools, and enhanced security measures. The new Pinnacle 21 Data Exchange module streamlines data ingestion from external sources, promising significant time savings in clinical studies, as evidenced by a recent pilot with a major pharmaceutical client.

Positive
  • Release of Pinnacle 21 Enterprise 5.2.0 improves regulatory compliance and data validation.
  • New Data Exchange module demonstrates time savings across 40 clinical studies during pilot with a top 10 pharmaceutical company.
  • Enhanced analytics for monitoring compliance with FDA's Technical Rejection Criteria.
Negative
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New automation, analytics and collaboration features save time and ensure regulatory compliance

PRINCETON, N.J., Aug. 05, 2022 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the feature release 5.2.0 of Pinnacle 21 Enterprise, the Company’s flagship software for validating clinical trial data for biosimulation and regulatory submissions. It also introduced the new Pinnacle 21 Data Exchange product, an integrated module that streamlines the process of ingesting clinical trial data from external sources.

“The volume and complexity of clinical data are growing at a fast pace and significantly extending end-of-study timelines,” said William F. Feehery, Ph.D., CEO of Certara. “Through these Pinnacle 21 releases, we are excited to deliver innovation that transforms labor-intensive processes and reduces time from data collection and analyses to submission.”

Pinnacle 21 Enterprise validates data quality and compliance with regulatory standards, enabling a clean data pipeline from sponsors to health authorities. The new Pinnacle 21 Data Exchange module ensures data integrity and regulatory compliance while empowering sponsors to maintain executive oversight to drive objective decisions.  

This release of Pinnacle 21 Enterprise 5.2.0 includes:

  • Analytics features to monitor progress in adherence to the FDA’s Technical Rejection Criteria, which came into effect in September 2021
  • Improved workflow and in-app communication to facilitate collaboration among teams, vendors, and sponsors
  • Actionable, searchable real-time notifications to keep users informed
  • Enhanced security with additional role-specific permissions

“This update of Pinnacle 21 Enterprise and new Data Exchange module meet the demands of an ever-changing industry with critical data compliance requirements,” said Max Kanevsky, chief technology officer of Certara Software. “In a recent pilot of Data Exchange with a top 10 pharmaceutical company, our client experienced meaningful time savings across 40 clinical studies. We are very pleased with these results and look forward to offering these updates to our customers.”

About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Certara Contact
Jieun W. Choe
jieun.choe@certara.com

Investor Relations Contact
David Deuchler
ir@certara.com

Media Contact
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com


FAQ

What new features were introduced in Certara's Pinnacle 21 Enterprise 5.2.0?

The new features include analytics for FDA compliance, improved workflow and communication tools, real-time notifications, and enhanced security with role-specific permissions.

How does Certara's new Data Exchange module benefit clinical studies?

The Data Exchange module streamlines data ingestion from external sources and has shown to save significant time across multiple clinical studies.

What company is behind the Pinnacle 21 software?

Certara, Inc. is the company releasing the Pinnacle 21 software, which is focused on biosimulation and regulatory submissions.

When was Pinnacle 21 Enterprise 5.2.0 released?

Pinnacle 21 Enterprise 5.2.0 was released on August 5, 2022.

What is the stock symbol for Certara, Inc.?

The stock symbol for Certara, Inc. is CERT.

Certara, Inc.

NASDAQ:CERT

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