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. 定制的 PKAssist 应用程序可以像数据库连接器一样简单，也可以像完整的自动化分析和报告解决方案一样复杂，该解决方案中包括符合监管要求的数据管理和符合 CDISC 的文件生成。
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.
公司必须按照美国 FDA 21 CFR 第 11 部分、技术要求国际协调会议 (ICH)、EudraLex 附录 11 和其他监管机构指导文件的要求，投入大量时间和资源来手动编写和开展用于软件执行的验证步骤。
Our validation consulting for Phoenix WinNonlin, NLME , and Integral leverages Certara’s team of validation professionals to meet FDA and OECD compliance requirements.