Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, 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.