This application simplifies and expedites the validation process for Phoenix WinNonlin software, which is used extensively for drug regulatory submissions
PRINCETON, NJ – Dec 7, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced the launch of its Phoenix® WinNonlin® Validation Suite™ 7.0.
Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation. Phoenix is used by 6,000 researchers at 1,500 biopharmaceutical companies and 200 academic institutions in 60 countries. Phoenix is also employed by many global regulatory agencies for submittal review, including seven divisions of the US Food and Drug Administration (FDA).
All computer systems and software used in regulatory submissions have to be validated to ensure correct performance. This requirement is included in the United States Food and Drug Administration’s (FDA’s) 21 CFR Part 11, the International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents.
“Our Phoenix WinNonlin Validation Suite 7.0 helps increase the efficiency of the drug development process by producing accurate, documented validation test results in days rather than weeks,” said Certara Vice President of Pharmacometric Solutions Nathan Teuscher, PhD. “Furthermore, by obviating the need to manually write and execute validation code, it frees up biopharma researchers to work on more strategic, higher value activities.”
Certara’s Phoenix WinNonlin Validation Suite 7.0 uses nearly 200 automated test scripts and a series of document templates to streamline the validation process and provide objective evidence of WinNonlin 7.0’s functionality. It compares the test output with standard, verified results, and then reports its findings in a Microsoft Word run report. This approach ensures rapid, consistent, error-free testing and lowers a project’s validation costs.
Phoenix WinNonlin Validation Suite 7.0 includes the following life cycle templates: Validation Plan, Phoenix WinNonlin Requirements Specification, Test Plan, Phoenix WinNonlin Traceability Matrix, and the Validation Summary Report.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions