The Phoenix™ platform is the industry’s premier software 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 simulation trends in both pre-clinical and clinical development. These services, led and implemented by Certara’s professional team of PK/PD software experts, include customized and ready-to-use solutions that span the breadth of the Phoenix platform.
PKAssist™ leverages Certara’s team modeling and simulation experts to build configurable software solutions to fill procedural gaps, automate routine processes, and integrate analysis tools with source data systems. A customized PKAssist application could be as simple as a database connector or as complex as a complete automated analysis and reporting solution that includes regulatory compliant data management and CDISC compliant file generation.
The Phoenix Technology Services team supports your implementation and integration of Certara Integral, a single, validated, 21 CFR Part 11 compliant data repository that streamlines clinical pharmacology workflows.
Integral is a next-generation cloud-based, software as a service (SaaS), validated data and model repository with an intuitive user interface for collecting, managing, and storing multiple types of data sets for analysis, sharing, and reporting of clinical pharmacology, pharmacometric, and all other clinical data.
Companies must invest significant time and resources to manually write and perform the validation steps used in software execution, 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.
Our validation consulting for Phoenix WinNonlin, NLME , and Integral leverages Certara’s team of validation professionals to meet FDA and OECD compliance requirements.