Phoenix CDISC Workflow Templates

Phoenix CDISC Workflow Templates

Automate the Preparation of NCA Clinical and Non-clinical Data in CDISC-ready Formats The Phoenix® CDISC Workflow Templates prepare non-compartmental analysis (NCA) data into the format required by the FDA for electronic submission of clinical (SDTM) or non-clinical (SEND) study data. Once your NCA is completed in Phoenix WinNonlin™, the CDISC Workflow Templates automate the creation of the SDTM […]

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Phoenix Technology Services

Phoenix Technology Services – Facilitating the Art and Science of Modeling and Simulation Phoenix® is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data. Phoenix Technology Services was established to help our clients leverage Phoenix software, systematize “best practices”, and to take advantage of modeling and […]

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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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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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