Hosted Software to Support Compliant PK/PD Analysis Workflows
ST. LOUIS--(BUSINESS WIRE)--
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.
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
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.
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."
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
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.