Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset
Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara's Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software . The combination of Pinnacle 21 Enterprise and SEND Explorer enables synergy for meeting global regulatory guidelines and delivering efficiency. The technology optimizes data analysis from a regulatory perspective and allows scientists to gain scientific insight through interactive toxicity data visualization. It also ensures FDA submission-ready SEND, SDTM, and ADaM datasets.
Pinnacle 21 Enterprise is used to validate compliance with the Clinical Data Interchange Standards Consortium (CDISC) standards, which are required by the U.S. Food & Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and recommended by China's National Medical Products Administration (NMPA) for evaluating regulatory submissions. Pinnacle 21 Enterprise software has been adopted by the FDA and PMDA as well as 24 of the top 25 biopharmaceutical companies by R&D spend.
SEND Explorer is a validated, web-based application that provides advanced viewing, data summarization and visualization capabilities for nonclinical study data. Using SEND Explorer, scientists generate visualizations of single and multiple toxicology studies to inform decisions and quickly address questions from health authorities.
"We expect that using Pinnacle 21 Enterprise will help KIT increase the quality of SEND Datasets for submission to regulatory agencies. In addition, SEND Explorer will help KIT provide advanced analysis including historical data and cross-analysis studies of toxicity tests, that enable sponsors to quickly address questions from the FDA." said Junyong Lee, Korea Country Sales Director at Certara.
"With SEND Explorer and Pinnacle 21 Enterprise, scientists can more effectively bridge the translational gap between the nonclinical and clinical phases and ensure that they are regulatory ready" added Leif E. Pedersen, President, Software at Certara.
Learn more about Certara software: https://www.certara.com/software/
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services that transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
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SOURCE: Certara
Emi Akatsu Emi.akatsu@certara.com
COMTEX_437807319/1006/2023-08-03T21:00:02