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Certara’s acquisition of Pinnacle 21 grants them access to their compliance validation software.
Certara, a biosciences company specializing in biosimulation, announced on Oct. 4th, 2021, that their acquisition of Pinnacle 21, a provider of software as a service (SaaS) solutions for clinical data fitness, has been completed. At closing, equity holders of Pinnacle 21 received approximately $250 million in cash considerations and 2,239,717 shares of Certara restricted common stock.
Through this acquisition, Certara can incorporate Pinnacle 21’s software into its support services. The software is a continually updated validation tool used to ascertain compliance to standards imposed by the Clinical Data Interchange Standards Consortium (CDISC).
Compliance with CDISC standards is required by FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for evaluating regulatory submissions. According to a Certara press release, the software has been adopted for use by FDA, PMDA and 22 of the top 25 pharmaceutical companies by R&D spending.
“We are pleased to welcome Pinnacle 21’s talented team to Certara,” said William F. Feehery, CEO of Certara, in the press release. “With Pinnacle 21’s software for high-quality clinical data standardization, we can together provide a broader portfolio of industry-leading software and technology-driven services to our customers worldwide. This transaction amplifies our capabilities to inform critical decisions that further de-risk and expedite the drug development process.”
“This is an exciting day for all of us at Pinnacle 21,” said Max Kanevsky, founder and CEO of Pinnacle 21, in the press release. “Certara’s global footprint and focus on growth fast-forward Pinnacle 21’s journey for continued success. I look forward to expanding our technology capabilities together to advance life-saving therapies to patients.”