Pinnacle Data Systems

Pinnacle 21, originally founded as Pinnacle Data Systems, is a leading provider of clinical data validation software and services for the global life sciences industry. The company is best known for developing OpenCDISC, the industry-standard tool used by regulatory agencies such as the FDA and PMDA, as well as hundreds of biopharmaceutical companies, to ensure clinical trial data complies with CDISC standards. Its flagship platform, Pinnacle 21 Enterprise, provides an end-to-end solution for data quality, compliance, and submission readiness, significantly accelerating the drug approval process. In 2021, the company was acquired by Certara for approximately $310 million to integrate its data validation capabilities into Certara's broader biosimulation and regulatory science portfolio.