Phoenix NLME Validation Suite

Phoenix NLME Validation Suite

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 end, companies must invest significant […]

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Integral: Next Generation Data Repository

Certara Integral™ is a single, validated, 21 CFR Part 11 compliant data repository that streamlines clinical pharmacology workflow Secure and pre-validated technology provides a single source of truth for your data providing multiple benefits Make data-driven decisions earlier in the development process Increase clinical pharmacology efficiencies Successfully pass audits by regulatory agencies Be confident in […]

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Pirana Software

Certara software support remains unchanged and is available 24/5 by calling (919) 589-2465 or through the support portal Certara.service-now.com/csm Pirana: A Leading Pharmacometrics Modeling Workbench Pirana is a flexible, extendible pharmacometrics workbench that provides modelers with structure, tools, and a graphical user interface to facilitate the iterative processes used to create pharmacometric models and perform […]

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Trial Simulator

Certara software support remains unchanged and is available 24/5 by calling (919) 589-2465 or through the support portal Certara.service-now.com/csm Certara Trial Simulator version 2.3 Powerful, Flexible, and Intuitive 9 out of 10 drugs in development fail to make it to market, costing pharmaceutical companies billions every year.1 One reason for these failures is suboptimal clinical trial […]

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Phoenix 8.1

Phoenix PK/PD Modeling and Simulation Software Certara’s Phoenix platform is the leading PK/PD modeling and simulation software used worldwide by 6,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA. Phoenix extends the winning formula of WinNonlin by combining its trusted algorithms with built-in, easy-to-use graphical user […]

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D360 Express

Scientific Data Informatics Hub for Discovery Research Small molecule drug discovery research requires the ability to access and understand biological, chemical, logistical, and computational data from a wide variety of sources. A major challenge for scientists is the significant time and resources needed to find and access this data quickly and efficiently in order to make […]

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IVIVC Toolkit

Certara software support remains unchanged and is available 24/5 by calling (919) 589-2465 or through the support portal Certara.service-now.com/csm Phoenix IVIVC Toolkit The Gold Standard for Predicting Pharmacokinetic (PK) Parameters from In Vitro Dissolution Data in Drug Development and Formulations. The Phoenix® IVIVC Toolkit™ creates and substantiates the Level A correlation as outlined in the FDA Guidance […]

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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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