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Benefits of PKS™ Reporter
The benefits of deploying PKS™ Reporter within your drug development enterprise include:
Improve Scientific Productivity: Standardize and Automate Routine Document Authoring Tasks
PKS Reporter helps you to implement and follow your SOPs through report templates that specify report layout, formatting and the location, type and format of specific content elements to be drawn from the PKS database. PKS Reporter guides you through insertion of study content, and updates to reflect the latest data.
Integrate Reports with WinNonlin, NONMEM®, SAS and Other Industry Standard Software
PKS Reporter accesses data and output from WinNonlin Enterprise and other tools, including SAS, NONMEM, SigmaPlot® and S-PLUS®, via PKS. PKS stores and traces changes to study data, analysis settings and results, as well as third-party files associated with a study. These objects, and even individual data points, are inserted into PKS Reporter documents as PKS tags. PKS tags are linked to their source PKS content. PKS Reporter notifies you when a tag is out of date, and ensures accurate updates to the latest data in PKS with a single button click.
Reduce QA overhead: Automate Report Updates and Validation
PKS Reporter draws on PKS as a controlled, validated source for pharmacokinetic data to be included in regulatory submissions. At the click of a button, QA personnel can confirm that a report contains the most recent, valid PKS data and analysis results. PKS Reporter flags out of date or invalid content, and provides quick, automatic update.
Ensure Secure, Distributed Access to Reports
Store PKS Reporter documents in PKS to make them accessible to all of your authorized team members from anywhere on your intranet. Report access and authoring requires read and write permission to the associated study in PKS.
Trace and Control Report Versions and Signatures
Every report update is saved as a new report version in PKS, with documented user name, time and reason for updates, for secure report change control and traceability. PKS Reporter’s Signature Tool tracks and stores required signatures, and provides e-mail notification of report completion and sign-off.
Pharsight® believes that deployment of a comprehensive and accessible PK/PD research knowledge management system will provide a foundation for a more rational and cost-effective drug development process, both improving scientific productivity and reducing information management overhead.
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