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 simulation trends in both pre-clinical and clinical development. These services, led and implemented by Certara’s professional team of modeling and simulation experts, include customized and ready-to-use solutions that span the breadth of the Phoenix platform.
Phoenix Workflow Templates have been developed to optimize R&D productivity, analysis time, minimize quality control checks, and achieve regulatory compliance. Pre-packaged templates are available for serial and sparse sampling for TK studies and CDISC STDM and SEND, which will provide sponsors and CROs with more effective knowledge transfer between databases and enable robust protocols for regulatory submission. Customized templates can also be developed for specific workflows and parameters.
Phoenix Plugin Services, such as PopPK data preparer, First-in-Human allometric scaling, CDISC data preparer, and dosing/treatment randomization builder, streamline data flow by providing access to data required for analysis and regulatory submission. The Phoenix QC and Comparison Tool plugin identifies workflow differences in a Phoenix project compared to a baseline project. These plugins integrate Phoenix with both upstream and downstream systems such as LIMS, study protocol, QA and compliance, compound management, dosing/treatment, randomization, and CDISC submission.
PKS Repository Services support client installations on Phoenix Knowledgebase Server™ (PKS) and PKS Online products, which provide a 21 CFR Part 11 compliant repository with full audit trail and version control for the storage of Phoenix biosimulation data.
Validation Services for Phoenix WinNonlin® and PKS leverage Certara’s team of in-house validation experts for IQ and OQ documentation, eliminating the burden on a client’s internal project team to meet regulatory compliance requirements for computer system validation.
Contact us to learn more how our Phoenix Technology Services team can help improve your R&D productivity and streamline compliance requirements.
|Certara is a CDISC Registered Solutions Provider|