PKS for Clinical Data Management: Improved Productivity and 21 CFR Part 11 Compliance
PKSTM, the Phoenix® Knowledgebase ServerTM, 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 Connect. It also works seamlessly with Certara's PK Automation tool, AutoPilotTM 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
Benefits :
Gain peace of mind
PKS is an IT infrastructure that supports secure, traceable, distributed access to study data, analyses, and reports. It is provides Validated storage of data and analyses for regulatory submissions.
Improve productivity
PKS is an integrated solution for PK automation and standardized reporting.
Enable compliance
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.
Supports Validation Environments
A validation suite (sold separately) for PKS supports onsite validation.
PKS Online - Data Access - anytime and anywhere
PKSTM Online is an internet-accessible implementation of PKS.
For more information call or email sales@4amsoftware.com.au
Disclaimer : The information on this Certara product line including names of other Software products/companies and brands, customers, customer statements and application labels are information taken from the original developer's website. 4am Software makes no additional claims to the information contained. Furthermore 4am Software Pty Ltd., does not make any claims of performance of the products, links with other related products or industry standards limited to PK/PD analysis or beyond. The sole purpose of information is to provide customers complete details in making a decision to purchase the products.