Data Access Anytime and Anywhere: Secure and Compliant PK/PD Data Management On Demand
PKSTM Online is an internet-accessible implementation of the Phoenix Knowledgebase Server (PKS) - Certara's PK/PD clinical data repository. PKS Online is integrated with Phoenix®, the industry-leading modeling and analysis platform, for state-of-the-art modeling and analyses. Certara provides flexible, subscription-based account options for PK scientists to support analytic work and discounted accounts with fewer access options for the specific needs of data managers and review staff. PKS Online is accessed via Phoenix Connect. 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
Save time and money on deployment
PKS Online lets customers realize the benefits of a compliant study data and analysis repository without upfront capital expenditure and deployment time.
Enable compliance
PKS supports 21 CFR Part 11 compliance and offers audit trails and version control.
Gain secure access to your data remotely
Secure encrypted user access from anywhere and at anytime requires only a standard desktop computer and a network connection.
Support collaboration
Your PKS Online schema can be shared with partners while the PKS security and authentication module controls access to present only those data that are required for cooperative work.
Save time and money on validation
Users need only expend minimal validation effort because PKS Online is already validated.
Decrease the burden on IT
PKS Online delivers the full set of PKS features without investing time and money on continuous IT support that would be required to manage an in-house system.
For more information or to purchase any of the modules please 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.