Contact Investors Careers Support Search English Model-informed Drug Development Data and Informatics Regulatory and Access Resources Company Home / News / Pinnacle 21 Awarded FDA Contract for 5 Years for Software and Services Pinnacle 21 Awarded FDA Contract for 5 Years for Software and Services October 28, 2021 Pinnacle 21 Enterprise software expedites regulatory review of all study submission data Princeton, N.J., October 28, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has awarded a five-year contract with Pinnacle 21 for ongoing software and related services support for the agency’s DataFit program. The DataFit program assesses data quality and performs data validation for standards compliance of all electronic clinical and non-clinical trial study submission data. This agreement is similar to the contracts awarded to Pinnacle 21 in 2015 and 2011 by the FDA. Pinnacle 21 was acquired by Certara in October 2021. “We are honored by the FDA’s continued support of our Pinnacle 21 Enterprise software and partnership,” said William F. Feehery, PhD., CEO of Certara. “We are dedicated to making the drug development and submission process more efficient and user-friendly for regulatory agencies and biopharmaceutical companies, helping to get crucial new therapies to patients sooner.” The DataFit custom implementation of Pinnacle 21 Enterprise meets the FDA’s data fitness assessment needs. The Pinnacle 21 Enterprise software enables the FDA to perform large-scale data validation and data quality reporting. FDA reviewers can assess and understand the quality of incoming submission data at a summary level in hours instead of the days or weeks required in a manual review. “Regulatory agencies are embracing change and innovation to streamline the submission process. As the compliance standards are not easy to navigate, our software helps to automate validation and identify issues,” said Max Kanevsky, chief technology officer of Certara’s Software business unit. “Furthermore, beginning last month, the FDA is enforcing the technical rejection criteria, which are applicable to submissions to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.” The contract includes the use of the Pinnacle 21 Enterprise software by the FDA to perform data validation for its DataFit program as well as Operations and Maintenance through IT professional services to the FDA. About Certara Certara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries. Certara Contact Jieun W. Choe jieun.choe@certara.com Media Contact: Ariane Lovell Finn Partners ariane.lovell@finnpartners.com Investor Relations Contact: David Deuchler Gilmartin Group ir@certara.com Media Contact: Services Anonymization and Redaction Cell and Gene Therapy Clinical Pharmacology Clinical Pharmacology Study Stewardship Complex Biologics Decision Analytics and Modeling Document Quality and Management Drug Development and Regulatory Strategy eCTD Authoring Templates French SNDS Data Access and Analysis See more Software PHOENIX™ PK/PD PLATFORM v 8.3 Phoenix WinNonlin Simcyp PBPK Simulator Quantitative Systems Pharmacology D360 Scientific Informatics Platform Integral Data Repository BaseCase Value Communication Software CODEx & Clinical Trial Outcomes Databases GlobalSubmit eCTD Submissions Software Phoenix WinNonlin Validation Suite See more Resources Articles Blogs Best of Blogs 2020 Case Studies Certara in the Press Certara University Certification Program Conferences Knowledge Base Podcasts See more Company Careers Certara Code of Conduct Contact Certara Leadership Legal Locations News Our Story Partners Privacy Center See more English Privacy Center Legal Copyright © 2020 Certara, USA. All rights reserved. By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookies Settings Accept All Cookies