Certara Inc., a global leader in biosimulation, announced it has signed a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. Pinnacle 21’s software tools are used to validate compliance to the Clinical Data Interchange Standards Consortium (CDISC) standards, which is required by the US FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for drug submissions and preferred by China’s National Medical Products Administration (NMPA).
“We are excited to welcome Pinnacle 21 to Certara as we execute on our strategy to invest in innovation to increase the use cases of biosimulation and grow adoption of our end-to-end platform,” said William F. Feehery, Ph.D., CEO of Certara. “The complementary acquisition of Pinnacle 21 marks an important expansion of Certara’s biosimulation and regulatory software and technology-driven services. The fuel for biosimulation, machine learning and statistics is high-quality, standardized data. Pinnacle 21 is a leader in biopharmaceutical data fitness, which streamlines quantitative analyses needed by our clients. This addition to our business creates compelling opportunities as we integrate and expand our complementary offerings.”
The acquisition will immediately establish Certara as a central participant in the data standardization process across the entire drug development life cycle. Data standards are complex and increasingly challenging to adhere to as the volume of data in clinical trials increases with the globalization of the biopharmaceutical industry and the growth of wearables and other health technologies. High-quality, standardized data are needed for efficient and precise analyses. Pinnacle 21’s proprietary validation software creates consistent, compliant, and high-quality datasets that reduce the risk of costly regulatory delays, while accelerating the speed and efficiency of developing and bringing lifesaving drugs to market.
“Certara is the ideal partner for Pinnacle 21’s exceptional team and customer base,” said Max Kanevsky, Founder and CEO of Pinnacle 21. “Both companies empower customers to collect, validate, and analyze data to inform critical decisions in drug development and achieve regulatory success. Joining forces with Certara tightens the link between clean data and informed analysis. We are eager to integrate and expand our software platforms to continue our mission to speed up life-saving therapies to patients."
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