Hosted Software to Support Compliant PK/PD Analysis Workflows
ST. LOUIS, MO – 2012 年 06 月 25 日 – Certara™, a leading provider of scientific software and consulting services to improve productivity and decision-making from drug discovery through drug development, announced that a Top 5 Pharma selected PKS Online™ as the platform of choice to support their regulatory compliant NCA analysis for clinical pharmacology.
Pharsight® Knowledgebase Server™ (PKS™) is the industry leading data management system for PK/PD analysis. In concert with Phoenix® WinNonlin®, PKS supports 21 CFR Part 11 compliance by providing a complete audit trail, change history, electronic signature and time/date stamp.
PKS Online™ is the hosted version of PKS. Benefits of this Software-as-a-Service approach include:
- Rapid deployment of a validated PK/PD data management system in as little as two weeks.
- All administration, software upgrades, validation and support are provided by experienced Certara personnel.
- No hardware or software investment by the customer is required.
- PKS Online can serve as a data exchange platform between internal and/or external collaborators.
“This is an important milestone for Certara,” said James Hayden, SVP of Sales and Marketing for Certara. “PKS has enjoyed great success in the last 10 years, but we have recently seen a shift toward PKS Online because customers experience the full benefits of their own data repository with minimal deployment effort and without any system administration overhead. In this case, PKS Online will be used by all clinical PK analysts at several global sites, showing how it can scale to provide support from an emerging biotech all the way to up to a multi-national pharma. Our clients tell us that eliminating the overhead associated with internal resources dedicated to validation, software and system upgrades, and general support, makes PKS Online attractive for even a small number of users.”
Certara is dedicated to improving human health through a broad spectrum of software products and consulting services, from molecular discovery through clinical development, with special focus on supporting translational approaches to drug development. Certara was formed by uniting industry leaders Tripos®, provider of innovative scientific software solutions and services enabling life science researchers to improve the efficiency of molecular discovery; Simcyp, a research-based company providing predictive pharmacokinetic and pharmacodynamics tools, workshops, and consultancy services; and Pharsight® Corporation, provider of software and scientific consulting services to improve productivity and decision-making in preclinical and clinical drug development. Each Certara family brand has a primary focus on a key phase within the drug discovery and development process; combined, they offer a unique set of capabilities for modeling, analysis, and simulation with scientific informatics that can enable the cross-disciplinary approaches necessary for translational science initiatives.
Diana O’Rourke, 314-951-3310
Director of Marketing