PRINCETON, N.J.— October 12, 2022 – Certara, Inc., a global leader in drug development software, today announced the release of the PK Submit™ 2.0. The software allows scientists to automatically create a complete electronic pharmacokinetic (PK) regulatory submission-ready data package within minutes during the normal process of setting up and executing a non-compartmental analysis (NCA). PK Submit™ is part of Phoenix™, Certara’s pharmacokinetic and pharmacodynamic (PK/PD) platform, which includes the gold standard WinNonlin software.
PK Submit automates the time consuming, error-prone and complex task of creating pre-clinical and clinical CDISC domains as part of the PK deliverable for regulatory submissions. This latest version incorporates additional features designed to increase efficiency in NCA workflows through automation.
“Lean workflows, where experts do not have to deal with tedious data handling, save time and allow scientists to focus on their core competencies. With the new feature sets, PK Submit™ 2.0 enables even higher R&D productivity,” said Leif Pedersen, president of Software at Certara. “With the integration of the industry-leading CDISC software, Pinnacle 21, into PK Submit™, we are taking an important step toward our goal of providing a seamless experience for users of Certara’s various software products. This integration now helps to make regulatory submission processes even more efficient.”
New capabilities in PK Submit™ include:
- Intuitive user interface to implement complex data transformations
- Added compliance for all current SEND and SDTM Implementation Guides
- Integration with Pinnacle 21 for validation, study data reviewer’s guide, and Define.xml generation
Learn more about PK Submit at https://www.certara.com/software/pk-submit-cdisc-technology-solution/.
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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.