Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

Rhea-AI Summary

Certara, a global leader in Biosimulation, announced that Korea Institute of Toxicology (KIT) will implement Certara’s Pinnacle 21 Enterprise and SEND Explorer software. The software optimizes data analysis and visualization for regulatory compliance and enables scientists to gain scientific insight. Pinnacle 21 Enterprise validates compliance with CDISC standards and has been adopted by FDA and PMDA. SEND Explorer provides advanced viewing and visualization capabilities for nonclinical study data.

Positive

• The implementation of Certara's software by KIT will increase the quality of SEND Datasets for submission to regulatory agencies, improving regulatory compliance and efficiency.
• The combination of Pinnacle 21 Enterprise and SEND Explorer allows scientists to generate visualizations of toxicology studies, enabling quick decision-making and addressing questions from health authorities.

Negative

• None.

Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines.

SEOUL, South Korea--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230720443872/en/

Emi Akatsu

Emi.akatsu@certara.com

Source: Certara

FAQ

What software will KIT implement?

KIT will implement Certara's Pinnacle 21 Enterprise and SEND Explorer software.

What are the benefits of using Pinnacle 21 Enterprise?

Pinnacle 21 Enterprise validates compliance with CDISC standards and improves regulatory compliance and efficiency.

What are the benefits of using SEND Explorer?

SEND Explorer provides advanced viewing and visualization capabilities for nonclinical study data, enabling quick decision-making and addressing questions from health authorities.