PKS™ – Pharsight® Knowledgebase Server™ for Clinical Data Management

Improved Productivity and 21 CFR Part 11 Compliance

PKS, the Pharsight Knowledgebase Server, is your answer to compliance requirements (think electronic records and audits) and the challenge to manage the increasing amount of data collected in clinical research for pharmacokinetic, pharmacodynamic, and pharmacometric analyses. PKS provides the technical infrastructure to effectively and securely manage your study data and associated analyses across drug 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 is the solution for protected and structured storage, access and change tracking for your study data, analyses and related files. The system is directly integrated with Certara’s industry-leading modeling and analysis tools Phoenix® WinNonlin® and Phoenix® NLME® 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, NLME and these tools. PKS can handle file formats of any type (ASCII, JPG, DOC, etc.), to capture content from a wide variety of visualization and analysis tools. Of course, PKS works seamlessly with Certara's PK Automation tool, AutoPilot™ Toolkit for Phoenix®, to provide a configurable software solution for standardized and regulatory-compliant routine analyses and automatic generation of PK output in tables and figures for final and intermediate reports and presentations.

Deployment Services

Certara's Deployment Services group optimizes the configuration and installation of Certara PK/PD data management solutions, including Phoenix and AutoPilot for Phoenix, 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 and validate PKS.

Key Benefits

Benefits

Secure, traceable, distributed access to study data, analyses, and reports.
Validated storage of data and analyses for regulatory submissions.
Support import (through PKS Data Connectors) and export of data in a variety of formats, including SDTM - the CDISC-defined standard for tabulation of study data.
Close integration with Phoenix WinNonlin and other industry standard analysis software.
Improved productivity through integrated solutions for PK automation and standardized reporting.

System Requirements

Pharsight Knowledgebase Server (PKS) is deployed as a three-tier application.

The PKS database is implemented in Oracle (Oracle 9i, 10g, or 11g, Standard and Enterprise Edition). Every operating system that is supported by Oracle is considered to be supported by PKS.
The PKS middle tier application is implemented in Java and runs in Apache Tomcat (distributed with PKS), or Oracle WebLogic. Again the PKS middle tier is independent of the underlying operating system.
PKS is accessed from the user’s desktop for data analysis and management using client applications, such as Internet Explorer and Pharsight’s analysis tools such as Phoenix WinNonlin, Phoenix Connect, or Phoenix NLME as well as AutoPilot Toolkit for Phoenix. For desktop operating system requirements, check the product information of the respective desktop tool.

PKS/PKS Online Features Tour

Learn about protected and structured storage, access and change tracking for your study data, analyses and related files

Users will access PKS through the Web browser interface to manage studies and scenarios. The “Studies” screen shows the Library Objects and Scenario versions that are related to a study. Easy-to-navigate pull-down menus allow to execute actions on the objects in PKS, for example, to extract data or add new data through PKS Data Connector transfer.

User-defined properties and attributes assure that studies can be identified and help with navigating the content in PKS – even if thousands of studies are stored in the repository.

The PKS Browser in Phoenix allows users to load data into Phoenix workflows for data management and analysis. All data and analysis results are stored in the Phoenix project which is saved back to PKS. Save Options allow users to expose analysis results in PKS, so that they are available to be accessed directly by other client programs.

When a Phoenix project is saved to PKS as a scenario, the user must enter an audit reason and has to provide the username and password. This becomes part of the audit history of the study and assures the tracking required for compliance.

The security and authentication module builds the basis for identifying each PKS user, so that the Audit Report will accurately reflect the history of changes that is tracked by PKS. Tracking changes on the level of individual data points – not just on the file level like other systems – gives customers peace of mind that regulatory requirements are met.