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Benefits of PKS™
The benefits of deploying PKS within your drug development enterprise include:
Secure, Traceable, Distributed Access to Data, Analyses and Reports
PKS™ provides ease-of-use and improved productivity for all members of your organization, through secure, distributed access to internally generated PK and PK/PD data. Use PKS to assemble, review and archive pharmacokinetic information in a systematic and organized manner. Your PKS administrators can grant permission to read, write and administer PKS studies to users and groups of users. Once completed, individual studies and analysis scenarios may be locked against further changes, and even archived for longer-term storage.
Validated Storage of Data and Analyses for Regulatory Submissions
PKS establishes a controlled, validated source for pharmacokinetic data to be included in regulatory submissions. It includes facilities for review and query of pharmacokinetic submission data, for use by both internal staff and regulatory reviewers. Audit trails track all changes to study data and analyses, giving the date, time, user name, and reason for every change.
PKS is intended to be validated as a “closed system” compliant with Electronic Records; Electronic Signatures; Final Rule (21 CFR Part 11) and Guidance for Industry – Computerized Systems Used in Clinical Trials.
Integration with WinNonlin® and Other Industry Standard Software
WinNonlin Enterprise communicates directly with PKS to load and save study data, analysis settings and results, as well as third-party files associated with a study. The PKS Client, included with PKS, provides similar access to PKS data and storage capacities for users of S-PLUS®, SigmaPlot®, SAS or NONMEM®. PKS Clients for Word and Excel enable documents in those applications to be saved and loaded directly to and from PKS studies.
Solutions for Automation and Standardized Reporting
PKS supports your best practices, within a department and across sites, with add-on capabilities to automate standard analyses and reports, through WinNonlin® AutoPilot™ and PKS Reporter.
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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