PKS for Clinical Data Management: Improved Productivity and 21 CFR Part 11 Compliance
PKS™, the Phoenix® Knowledgebase Server™, is a solution for protected and structured storage, access and change tracking for clinical study data, analyses and related files. It is integrated with Phoenix, the industry-leading modeling and analysis platform, for state-of-the-art modeling and analyses. PKS is accessed via Phoenix. It also works seamlessly with Certara’s PK Automation tool, AutoPilot™ Toolkit for Phoenix, to provide a configurable software solution for standardized and regulatory-compliant routine analyses and automatic generation of PK output in tables and figures for final and intermediate reports and presentations. With PKS, users can:
- Capture, manage, and store study data and associated analyses across drug development programs or indications in a secure, regulatory-compliant environment
- Analyze, summarize, and report the knowledge relating to both existing drugs and new compounds
- Support import (through PKS Data Connectors) and export of data in a variety of formats, including SDTM—the CDISC-defined standard for tabulation of study data
Furthermore, organizations can easily expand PKS implementation to encompass any and all files and content beyond PK/PKD data, including warehousing, managing, sharing, and versioning any Microsoft application document, csv file, SAS file, and more.
Gain peace of mind
PKS is an IT infrastructure that supports secure, traceable, distributed access to study data, analyses, and reports. It provides validated storage of data and analyses for regulatory submissions.
PKS is an integrated solution for PK automation and standardized reporting.
PKS supports 21 CFR Part 11 compliance and offers audit trails and version control.
No need to make additional purchases
PKS is integrated with Phoenix WinNonlin and other industry standard analysis software. PKS can also be used as a general repository for all files and content.
PKS Online Data Access—Anytime and Anywhere
PKS™ Online is an internet-accessible implementation of PKS.