PKS Reporter - Pharmacology Software

Reports for internal use or regulatory submission cost pharmaceutical R&D organizations considerable staff resources to transform data, create tables and graphs, format and edit documents, validate data references and analyses, and update documents when new data are received. This work can take skilled researchers away from more productive tasks. Much of the overhead, repetition, and potential for error can be minimized by moving to an automated, standardized system to produce regulatory reports. Moreover, secure storage and version control can alleviate tedious "housekeeping" related to change tracking, document management and sign-off.

Pharsight® has developed PKS Reporter to address the need for streamlined, systematic, and automated report generation and signature. Using the Pharsight Knowledgebase Server™ (PKS™) as an underlying source of secure, regulatory-compliant report content, PKS Reporter allows researchers to use familiar tools such as WinNonlin® and Microsoft Word® to construct, update, review and approve any type of report.

PKS Reporter is directly integrated with PKS, as both a source of report content and a secure repository for report storage and version control. PKS Reporter links reports in Microsoft Word directly to PKS, where it draws report content from data and modeling results created in WinNonlin Enterprise, NONMEM®, SAS and other industry-standard modeling and analysis tools. In addition, PKS Reporter is designed to work with Pharsight's PK Automation tool and will pick up tables and graphs automatically created by WinNonlin AutoPilot. From within Microsoft Word, researchers can browse the PKS database, loading objects and values drawn from various PKS studies and analysis scenarios. When the source data change, PKS Reporter marks its content as out of date, ready for automatic update. QA staff can automate the verification of report data by simply opening the document and selecting to have all references checked. Your team can create standardize report templates specifying report layout, formatting and specific content elements. Report sign-off is smooth and automatically tracked with Reporter's signature tool and e-mail notification.

Improve scientific productivity: standardize and automate routine document authoring tasks.
Link reports to output of WinNonlin, AutoPilot, and other industry standard software.
Reduce QA overhead: automate report updates and validation.
Ensure secure, distributed access to reports.
Trace and control report versions and signatures.

Software Link: PKS Reporter - Pharmacology Software

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