Core Insights - Certara, Inc. has launched Pinnacle 21 Enterprise Plus, a solution designed to enhance the efficiency of clinical and statistical programmers in creating and managing data specifications for CDISC SDTM and ADaM datasets, achieving a 50% reduction in time spent on drafting mapping specifications [1][2]. Company Overview - Certara is a global leader in biosimulation, providing software and services that accelerate drug discovery and development, with a client base of over 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [7]. Product Features - Pinnacle 21 Enterprise Plus offers a unified, collaborative workspace that addresses the limitations of traditional spreadsheet-based methods, such as errors and lack of version control [2]. - The solution is purpose-built for clinical and statistical programmers, allowing most teams to go live in less than a month [4]. - The platform supports compliance with both CDISC and company-specific standards through configurable columns, ensuring maximum flexibility [8]. - It facilitates seamless integration with downstream programming tools like SAS and R via application programming interfaces (APIs) [8]. Strategic Importance - The launch of Pinnacle 21 Enterprise Plus is seen as a significant milestone in Certara's roadmap, aimed at building a future-proof platform for end-to-end data standardization and validation [5]. - The innovations introduced are expected to shorten cycle times and accelerate regulatory submissions of new therapies, benefiting patients [3]. Market Position - Certara's Pinnacle 21 solutions are trusted by over 130 organizations globally, including leading biopharmaceutical companies and regulatory agencies like the US FDA and Japan's PMDA, reinforcing its leadership in clinical data standardization and validation [5].