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Pharsight® Knowledgebase Server™ Features

Pharsight designed PKS™ as a secure research management system specifically suited to the needs of clinical pharmacology and drug metabolism researchers. Key features include:

  • Direct integration with WinNonlin® (Phoenix™ WinNonlin® and WinNonlin® 5) and Phoenix NLME™ for industry-standard PK and PK/PD modeling capabilities
  • Phoenix Connect™ desktop application for managing S-PLUS®, SigmaPlot®, SAS®, R, and NONMEM® analyses in PKS
  • Study Creation wizard to assist loading of study data via Pharsight's desktop client products
  • Web-based Query Tool and configurable Data Explorer tool to search, select and download study data
  • Web client administrative interface to archive, restore or lock and unlock data, and administer user permissions (system ADMIN users only)
  • PKS Dada Connector to exchange data with other data management systems including Laboratory Information Management systems (LIMS), SDTM (CDISC) formatted data, Excel and SAS Transport formatted flat files, and other ODBC or JDBC compliant sources
  • Export of study data into files that are formatted according to the SDTM standard format as defined by CDISC for tabulation of study data
  • Online Help system detailing setup, usage instructions and data requirements

Validation

Pharsight Knowledgebase Server is specifically designed to meet the regulatory compliance and validation needs of clinical pharmacology and drug metabolism groups.

Pharsight's products are widely used by pharmaceutical companies, academic and research institutions, as well as regulatory agencies. Multiple of these organizations have audited and approved Pharsight's software and development methods as suitable for use under their GLP, GCP, and GAMP compliance/standards. Pharsight's products are developed using standard, well-documented Software Development Life Cycle (SDLC) processes and procedures, to enable users of Pharsight's products to be GLP/GCP/GAMP compliant. Pharsight systematically validates its products as part of its software development and delivery process. But there is more to being GLP/GCP/GAMP compliant than simply buying well-documented, well-tested, well-developed software. GCP/GLP compliance also involves what users do after the purchase to validate the operation of the system within their environment and to use the software properly with written Standard Operating Procedures (SOPs).

21 CFR Part 11 Compliance

Pharsight has been working with our customers to help them achieve compliance with 21 CFR Part 11 (Electronic Records; Electronic Signatures; Final Rule) regulations. Within the Phoenix framework, the PKS repository together with Phoenix Connect and the other Phoenix-based tools provide the technical means for achieving compliance in a perfectly integrated analysis environment.

Appropriate implementation of PKS, together with your Standard Operating Procedures, can achieve full compliance with 21 CFR Part 11. PKS uses electronic signatures and audit trails to store and manage PK/PD data and analysis results from WinNonlin, NLME, AutoPilot Toolkit, and other analysis tools.

 

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