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Pharsight® Knowledgebase Server™ (PKS™) — PK Data Management

Read about FDA's use of PKS

Pharsight Knowledgebase Server (PKS) provides the technical infrastructure to effectively and securely manage your pharmacokinetic/pharmacodynamic data and associated analyses across development programs or indications. With PKS, your knowledge relating to both existing compounds and new chemical entities is captured, stored, managed, analyzed, summarized and reported upon in a secure, regulatory-compliant environment. 

The Pharsight Knowledgebase Server (PKS) provides protected, structured storage, access and change tracking for your data, analyses and related files. PKS is directly integrated with WinNonlin® Enterprise, Pharsight’s industry-leading PK/PD modeling and analysis tool, for state-of-the-art modeling, analyses, as well as direct access to any ODBC-capable data source. In addition, PKS includes a desktop client to interface with SAS, NONMEM®, S-PLUS® and SigmaPlot®, and add-ins to manage Microsoft® Word and Excel documents. PKS can save file formats of any type (ASCII, JPG, DOC, etc.), to capture content from a wide variety of visualization and analysis tools.

Using WinNonlin or another PKS client, your scientists access data stored in PKS studies, then create and store analysis scenarios that capture models, analysis settings and results. Output is linked to the underlying study data; changes to the data tag related output for update. Each change is tracked in an audit trail, with electronic signature information including the date, user and reason for change. PKS improves traceability and management of data, analysis settings, output and reports, reducing file management overhead and enhancing data usage across your development effort.

PKS is directly integrated with Pharsight's WinNonlin® AutoPilot™ (requires WinNonlin Enterprise) to provide a configurable software solution for standardized, regulatory-compliant, secure and automatic generation of routine analyses and reports.

Pharsight Deployment Services

Pharsight Deployment Services optimizes the configuration and installation of Pharsight PK/PD data management solutions, including PK Automation, 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 PKS.
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Benefits

  • Secure, traceable, distributed access to data, analyses and reports.
  • Validated storage of data and analyses for regulatory submissions.
  • Integration with WinNonlin and other industry standard software.
  • Improved productivity through solutions for automation and standardized reporting.

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