Statements that are not historical facts, including statements about Certara’s beliefs and expectations, are forward-looking statements. Private Securities Litigation Reform Act of 1995. These statements are made under the “safe harbor” provisions of the U.S. This press release contains forward-looking statements. Streamlined approvals bring life-saving medicines to patients faster. Our platform validates data quality and compliance with CDISC standards, enabling a clean data pipeline from worldwide sponsors to health authorities, including the FDA, PMDA and NMPA.
#CERTARA WINNONLIN SOFTWARE#
Pinnacle 21 is a global leader in software for preparing clinical trial data for regulatory submission. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries. I look forward to expanding our technology capabilities together to advance life-saving therapies to patients.”Ĭertara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. “Certara’s global footprint and focus on growth fast-forward Pinnacle 21’s journey for continued success. “This is an exciting day for all of us at Pinnacle 21,” said Max Kanevsky, Founder and CEO of Pinnacle 21. Pinnacle 21’s current software applications will continue to be supported, updated and developed. Pinnacle 21’s Enterprise software is adopted by the FDA and PMDA as well as 22 of the top 25 biopharmaceutical companies by R&D spend. Food & Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for evaluating regulatory submissions. Pinnacle 21’s software is used to validate compliance to the Clinical Data Interchange Standards Consortium (CDISC) standards, which are required by the U.S. This transaction amplifies our capabilities to inform critical decisions that further de-risk and expedite the drug development process.” “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. “We are pleased to welcome Pinnacle 21’s talented team to Certara,” said William F.
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#CERTARA WINNONLIN UPDATE#
Certara will update financial guidance when the Company releases third quarter 2021 earnings in November. The transaction is expected to be accretive to Certara’s revenue, revenue growth, and adjusted EBITDA. At closing, equity holders of Pinnacle 21 received approximately $250 million in cash consideration and 2,239,717 shares of Certara restricted common stock, subject to certain customary closing adjustments. (Nasdaq: CERT), a global leader in biosimulation, today announced the completion of the previously announced transaction to acquire Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance and submission readiness. 04, 2021 (GLOBE NEWSWIRE) - Certara, Inc.
#CERTARA WINNONLIN PDF#
PDF Version Complementary technologies accelerate and help assure success in the drug development process