Pharsight® Knowledgebase Server™ (PKS™) provides the technical infrastructure to effectively and securely manage your pharmacokinetic / pharmacodynamic data and associated analyses across development programs or indications. With PKS, your knowledge relating to both existing drugs and new compounds is captured, stored, managed, analyzed, summarized and reported upon in a secure, regulatory-compliant environment.
PKS provides protected, structured storage, access and change tracking for your data, analyses and related files. PKS is directly integrated with Phoenix™ WinNonlin® and Phoenix™ NLME™ Pharsight?s industry-leading modeling and analysis tools, for state-of-the-art modeling and analyses. Through the PKS plug-in that is included in the Phoenix™ Connect™ product, PKS also integrates 3rd party tools such as SAS®, NONMEM®, S-PLUS® R, and SigmaPlot® and supports a seamless workflow between WinNonlin and these tools. PKS can save file formats of any type (ASCII, JPG, DOC, etc.), to capture content from a wide variety of visualization and analysis tools.
Using Phoenix Connect, Phoenix WinNonlin, Phoenix NLME , or a Web browser, your scientists access data stored in PKS studies, then use Phoenix workflows that include WinNonlin or supported 3rd party analysis tools to create and store analysis scenarios that capture models, analysis settings and results. Output is linked to the underlying study data; changes to the data tag related output for update. Each change is tracked in an audit trail, with electronic signature information including the date, user and reason for change. PKS improves traceability and management of data, analysis settings, output and reports, reducing file management overhead and enhancing data usage across your development effort.
Of course, PKS works seamlessly with Pharsight's PK Automation tool AutoPilot™ Toolkit for Phoenix® to provide a configurable software solution for standardized, regulatory-compliant, secure routine analyses and automatic generation of PK output (tables and figures) for final and intermediate reports and presentations.
Pharsight Deployment Services
Pharsight Deployment Services optimizes the configuration and installation of Pharsight PK/PD data management solutions, including AutoPilot and PKS Reporter, to fit your business needs and environment. Our experts in project management, PK/PD best practices, and large-scale systems implementation bring extensive experience, a proven migration methodology and end-to-end project management to help you deploy PKS.
Benefits
- Secure, traceable, distributed access to data, analyses and reports.
- Validated storage of data and analyses for regulatory submissions.
- Support import (through PKS Connectors) and export of data in a variety of formats, including SDTM - the CDISC-defined standard for tabulation of study data.
- Integration with Phoenix WinNonlin and other industry standard software.
- Improved productivity through solutions for automation and standardized reporting.
Software Link: Softwares in Pharmacology - Pharsight Knowledgebase Server
