Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset
04 Août 2023 - 3:00AM
Business Wire
Software will aid optimizing pre-clinical data
management in accordance with global standards and guidelines.
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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Emi Akatsu Emi.akatsu@certara.com
Certara (NASDAQ:CERT)
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