Certara announces Pinnacle 21 Enterprise Plus, enhancing data specification management for clinical programmers, improving submission efficiency and compliance.
Quiver AI Summary
Certara, Inc. has launched Pinnacle 21 Enterprise Plus, a new solution designed for clinical and statistical programmers to efficiently create, manage, and reuse data specifications for generating CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, which are crucial for regulatory submissions. This innovative platform addresses the limitations of traditional spreadsheet methods by providing a collaborative workspace that enhances accuracy and reduces drafting time for mapping specifications by 50%. The no-code interface allows for easy integration with tools like SAS and R, streamlining the submission process and reducing delays. Certara's Pinnacle 21 solutions are already trusted by over 130 organizations, including major regulatory agencies, emphasizing the company’s leadership in clinical data standardization and validation.
Potential Positives
- Introduction of Pinnacle 21 Enterprise Plus demonstrates Certara's commitment to innovation in the biosimulation space, enhancing efficiency for clinical and statistical programmers.
- The no-code interface is projected to reduce the time spent drafting mapping specifications by 50%, significantly improving productivity.
- Pinnacle 21 Enterprise Plus enables compliance with both CDISC and proprietary standards, providing maximum flexibility for users.
- Certara's solutions are trusted by over 130 organizations globally, including major biopharmaceutical companies and regulatory agencies, reinforcing its reputation as a leader in clinical data standardization and validation.
Potential Negatives
- Potential over-reliance on a new system may lead to operational disruptions during the transition from traditional methods to the new platform.
- Claims of "50% reduction in time" may set unrealistic expectations among clients, leading to dissatisfaction if the results do not meet those claims.
- The introduction of a new enterprise solution could necessitate additional training and adaptation for users, affecting short-term productivity.
FAQ
What is Pinnacle 21 Enterprise Plus?
Pinnacle 21 Enterprise Plus is a solution for efficiently creating, managing, and reusing data specifications for clinical datasets like SDTM and ADaM.
How does Pinnacle 21 Enterprise Plus improve data management?
The platform provides a unified workspace that reduces errors and enhances collaboration while offering a no-code interface for ease of use.
What are the benefits of using Pinnacle 21 Enterprise Plus?
Key benefits include support for industry standards, seamless integration with programming tools, and faster submission cycle times for clinical trials.
How quickly can teams implement Pinnacle 21 Enterprise Plus?
Most teams can go live with Pinnacle 21 Enterprise Plus in less than a month, ensuring a swift transition to improved data management.
Who are the intended users of Pinnacle 21 Enterprise Plus?
The solution is purpose-built for clinical and statistical programmers who require reliable tools for data standardization and validation in clinical research.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CERT Hedge Fund Activity
We have seen 112 institutional investors add shares of $CERT stock to their portfolio, and 167 decrease their positions in their most recent quarter.
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$CERT Analyst Ratings
Wall Street analysts have issued reports on $CERT in the last several months. We have seen 3 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- UBS issued a "Buy" rating on 08/07/2025
- Keybanc issued a "Overweight" rating on 07/14/2025
- Barclays issued a "Overweight" rating on 05/08/2025
To track analyst ratings and price targets for $CERT, check out Quiver Quantitative's $CERT forecast page.
$CERT Price Targets
Multiple analysts have issued price targets for $CERT recently. We have seen 5 analysts offer price targets for $CERT in the last 6 months, with a median target of $15.0.
Here are some recent targets:
- Dan Leonard from UBS set a target price of $15.0 on 08/07/2025
- Scott Schoenhaus from Keybanc set a target price of $15.0 on 07/14/2025
- Sean Laaman from Morgan Stanley set a target price of $16.0 on 07/03/2025
- Luke Sergott from Barclays set a target price of $14.0 on 05/08/2025
- Joe Vruwink from Baird set a target price of $13.0 on 04/11/2025
Full Release
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.
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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
[email protected]
Media contact:
Alyssa Horowitz
[email protected]
