Using PKS™ with Phoenix™ Connect™ and Phoenix™ WinNonlin®

The following workflow outlines a common use of PKS to manage data analysis in Phoenix WinNonlin which is enabled by the PKS plug-in that is included in the Phoenix Connect product.

PKS Study Creation

For all PKS interaction, the user needs to sign-in to PKS with a username and the password. The Phoenix will stay connected during a session, though it will ask to confirm the password for certain transactions.

Longitudinal data in many common formats (Excel, ASCII, ODBC compliant database, more) can be loaded into Phoenix WinNonlin or Phoenix Connect. Alternatively, the data may be imported from another database via the PKS Web Client, using the customizable PKS Connector. For the manual process, the first step is to create a study using the PKS menu options in Phoenix. During the study creation, PKS asks for searchable metadata about the study design, compound and development program.

On the Study Data tab, the source for the study data is selected and the data are mapped.

When saving the study, an Audit Reason needs to be entered and PKS will trace all details of the transaction.

Modeling and Analysis Scenarios

Once stored in PKS, a study view needs to be created to prepare the data for loading into Phoenix WinNonlin for analysis. A dialog will appear that allows to select the data that will be used for analysis. Study Views allow to combine data from different studies or to selectively use data based on characteristics, for eample to separat Urine and Plasma data. Study Views retain an active link to the original studies, i.e. if the study data are updated, the Study View will use the new data.

The study data are then loaded into Phoenix WinNonlin and the analysis can be performed. Using the New Scenario command will create a project in Phoenix WinNonlin and allow the analysis.

Analysis results, settings and (optionally) output, including saved to PKS as a scenario. Again, an Audit Reason needs to be entered and the user needs to supply the password to authorize the change in PKS.

Study and Scenario Updates

To update study data, the study data will be loaded into PKS using the Edit Study Data command.

When the updated study is saved to PKS, changes are tracked in PKS, noting the user name, date and reason for every change.

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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