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Certara acquires Pinnacle 21, a leader in standardization software for clinical data in medicine

Certara, Inc. (NASDAQ: CERT), a global leader in biomimicry, announced today that it has signed a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. Pinnacle 21’s software tools are suitable for validating data for compliance with Clinical Data Interchange Standards Institute (CDISC) standards, which are required for submission of drug applications to the U.S. Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) , which is also the preferred standard of China’s National Medical Products Administration (NMPA).

“We welcome Pinnacle 21 to Certara as we implement an innovative investment strategy to drive the use of biomimicry and increase the utilization of our end-to-end platform,” said Dr. William F. Feehery, CEO of Certara. 21’s complementary acquisition marks an important expansion of Certara’s biosimulation and regulatory software and technology-driven services. High-quality, standardized data is the foundation of biosimulation, machine learning and statistics. Pinnacle 21 is a leader in biopharmaceutical data fitting This business acquisition will create compelling opportunities as we integrate and expand our complementary offerings.”

Immediately after this acquisition, Certara will be a central player in the data standardization process throughout the drug development lifecycle. With the globalization of the biopharmaceutical industry and the development of wearable devices and other health technologies, the volume of data in clinical trials will continue to increase, and data standards will become increasingly complex and difficult to comply with. Efficient and precise analysis requires high-quality, standardized data. Pinnacle 21’s patented validation software creates consistent, compliant and high-quality datasets that reduce the risk of costly regulatory delays while increasing the speed and efficiency of drug development and time to market.

“Certara is an ideal partner for Pinnacle 21’s exceptional team and customer base,” said Max Kanevsky, founder and CEO of Pinnacle 21. “Both companies help customers collect, validate and analyze data for drug development. The key decisions of our company are informed to help clients pass regulatory approvals. The alliance with Certara can further strengthen the link between effective data and informed analytics. We are eager to integrate and expand our software platform to continue our mission of delivering faster for Patients bring life-saving treatments.”

Pinnacle 21 drives the data validation software market, especially for clinical trials, and the company has more than 130 corporate customers, including 22 of the top 25 biopharmaceutical companies by R&D spending, as well as FDA and PMDA data, along with Over 1000 organizations use its open source community software.

key transaction terms

The transaction has an enterprise value of $310 million, with Pinnacle 21 shareholders receiving $250 million in cash consideration and Certara stock valued at $60 million, subject to the terms of the agreement. Immediately after the transaction closes, it is expected to boost Certara’s top line, revenue growth rate and adjusted EBITDA margin.

The transaction, which has been unanimously approved by the boards of directors of Certara and Pinnacle 21, is expected to close early in the fourth quarter of 2021, subject to customary regulatory approvals and other closing conditions.

Webcast and Conference Call Details

Certara will host a conference call today, August 5, 2021 at 5:00 p.m. ET to discuss its second quarter 2021 financial results and the impact of the acquisition of Pinnacle 21. A webcast of the conference call will be available on the “Investors” section of the company’s website at https://ir.certara.com/. The webcast will remain on the website for approximately one year after the conference call.


Jefferies LLC is serving as financial advisor to Certara and Simpson Thacher & Bartlett is serving as legal advisor to Certara. Fairmount Partners is serving as financial advisor to Pinnacle 21 and Cozen O’Connor is serving as legal advisor to Pinnacle 21.

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