Validation Suite

Validation Suite

Phoenix WinNonlin Validation Suite 8.1 As required by US FDA’s 21 CFR Part 11, International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents, computer systems used in the pharmaceutical industry and output from software used in regulatory submissions must be validated to assure proper performance. To this […]

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PKS Online

Data Access Anytime and Anywhere: Secure and Compliant PK/PD Data Management On Demand PKS™ Online is an internet-accessible implementation of the Phoenix Knowledgebase Server (PKS)—Certara’s PK/PD clinical data repository. PKS Online is integrated with Phoenix®, the industry-leading modeling and analysis platform, for state-of-the-art modeling and analyses. Certara provides flexible, subscription-based account options for PK scientists […]

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Pre-clinical Safety Store

PCSS: A CDISC SEND-based Data Repository for Pre-clinical Study Data Certara’s PCSS™ (Pre-clinical Safety Store) is a queryable repository in which pre-clinical study data can be uploaded, validated and matched for desired terminology. When used in conjunction with Certara’s D360™, PCSS is an invaluable tool for study managers, toxicologists, pathologists, and data scientists. It supports on-going […]

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D360

Data Informatics Platform for Discovery Scientists Drug discovery research requires understanding complex chemical, biological, logistical, and computational data from a wide variety of data sources. A key challenge for discovery scientists is the ability to efficiently access the most current and relevant data from internal and external data sources, ideally in a consolidated and cohesive project […]

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Scientific Informatics

Certara’s Informatics Platform Facilitates Scientific Data Access, Analysis, and Collaboration within an Organization and Amongst Development Partners D360 Data Informatics Platform for Discovery Scientists D360™ is the industry-leading scientific data informatics hub used globally by over 5,000 discovery research scientists. It was designed to meet the discovery researcher’s workflow needs by providing a self-service data […]

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Phoenix WinNonlin

Phoenix WinNonlin 8.1: The Industry Standard for NCA and PK/PD Modeling and Simulation Phoenix® WinNonlin® is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling. Integrated tools for data processing, post-analysis processing, table creation, graphics, and compliance create an all-in-one collaboration workbench used by scientists, reviewers, medical writers, and quality assurance staff […]

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Phoenix Knowledgebase Server (PKS)

PKS for Clinical Data Management: Improved Productivity and 21 CFR Part 11 Compliance PKS™, the Phoenix® Knowledgebase Server™, is a solution for protected and structured storage, access and change tracking for clinical study data, analyses and related files. It is integrated with Phoenix, the industry-leading modeling and analysis platform, for state-of-the-art modeling and analyses. PKS […]

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Phoenix CDISC Navigator

CDISC SDTM/SEND PK Data Preparation Preparation of clinical (SDTM) and non-clinical (SEND) datasets, while time-consuming and cumbersome, is a critical task required for achieving compliance of electronic submissions. Phoenix CDISC Navigator provides a user-friendly interface that seamlessly imports CDISC data into an analysis-ready format, and then exports CDISC-formatted PK parameters for regulatory submission. It is […]

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Phoenix NLME

Phoenix NLME: The Modern Population PK/PD Modeling Tool for Today’s Scientists Phoenix® NLMETM software is a population modeling and simulation solution for scientists with varying levels of experience—from the novice PK/PD scientists to the most advanced modelers. This comprehensive package includes integrated data preparation, modeling, and graphics tools with the same user interface that is used […]

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PK/PD Modeling and Simulation

Phoenix: The Most Comprehensive and Widely-used Software for Pharmacokinetic (PK), Pharmacodynamic (PD), and Toxicokinetic (TK) Modeling and Simulation Phoenix®, the industry’s premier PK/PD modeling and simulation software workbench, is used by over 6,000 scientists in 60 countries at nearly 2,000 institutions, including the top 50 global pharmaceutical companies, academic institutes, and research foundations. Regulatory agencies, including 11 divisions […]

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