Using PKS™

The following workflow outlines a common use of PKS™ to manage data analysis in WinNonlin® or the PKS Client.

PKS Study Creation

Longitudinal data in many common formats (Excel, ASCII, ODBC compliant database, more) can be loaded into WinNonlin of the PKS Client, then mapped to appropriate data fields in a PKS study.

Alternately, the data may be imported from another database via the PKS Web Client, using the customizable PKS Connector. In addition to subject, dose, demographic and related data, PKS stores searchable metadata about the study design, compound and development program.

Note that each exchange of data with PKS requires a valid user name and password with appropriate permissions to view and/or alter the PKS study being accessed.

Modeling and Analysis Scenarios

Once stored in PKS, study data can be loaded to WinNonlin or the PKS Client for analysis. The analysis settings and (optionally) output, including outside files such as SAS or SigmaPlot® scripts, graphics and reports, are saved to PKS as a scenario.

Study and Scenario Updates

Updates to the study data are tracked in PKS, noting the user name, date and reason for every change.

Existing scenarios retain a link with the study data, and are marked as out of date if the study data change. Scenarios can be reloaded into WinNonlin or the PKS Client and refreshed to use the most recent data, then saved to PKS as a new version.

Report Generation and Sign-Off

Organizations that opt to purchase the PKS Reporter can manage report creation, updates and signature through PKS. To create a report, researchers can open a pre-defined PKS Reporter template, defining layout, formatting, boilerplate content and locations of specific report content. The researcher specifies which PKS study and scenario should be used to populate content text, tables and graphics. The report can then be saved to PKS for secure version tracking and electronic signatures via the PKS Reporter Signature Tool.

Study Queries and Administration

PKS provides a Web interface to support study management and queries.  Users with appropriate permissions can view and query study data, manage units and study metadata, lock or unlock studies and scenarios against changes, and import data from outside databases via the PKS Connector.

Database and Study Administration

PKS administrators control user access and study status through a Web-based interface.

User access permissions are set on both study-by-study and system-wide levels, to individual user and/or roles. The roles can then be assigned to groups of users.

Administrators can view audit reports, noting all data entries and changes for a selected study and/or scenario.

Studies that are no longer in use can be archived to a separate database instance for storage. Archived studies are quickly brought back into the main database through the PKS archive/restore feature.

 

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