Pharsight's Reporting and Analysis Services Business Unit to Leverage New Validated Data Managem...(ch as WinNonlin and WinNonlin AutoPilot ...)

About Pharsight Reporting and Analysis Services

Pharsight's Reporting and Analysis Services (RAS) unit provides a broad spectrum of world-class expertise in pharmacokinetics (PK), pharmacodynamics (PD), statistical analysis, and report writing. RAS scientists make use of Pharsight's industry-leading software tools to provide timely, high-quality analyses and reports for pre-clinical and clinical studies supporting sponsors' new drug application submissions under Module 5 (Clinical Study Reports) of ICH's Common Technical Document for Regulatory Filing. RAS is principally located in Montreal, Canada and serves all major drug development geographies, with business representatives in North America, Europe, and Japan.

About PKS

PKS is a high-productivity enterprise data repository that manages modeling and simulation data. PKS enables pharmaceutical and biotechnology companies to better manage and control preclinical and clinical PK/PD data and analyses, thus supporting higher modeling productivity as called for in the FDA's Critical Path Initiative. Companies also use PKS to build an electronic PK/PD data management architecture that complies with the FDA's 21 CFR Part 11 regulation, for management of electronic records. PKS is directly integrated with WinNonlin Enterprise, Pharsight's industry-leading PK/PD modeling and analysis tool, for state-of-the-art modeling and analyses, and supports direct access to any ODBC-capable data source. PKS also supports analysis with leading tools such as NONMEM(R), and SAS(R), and data import from leading clinical data management and laboratory information management systems such as Watson LIMS(TM). PKS software is designed to complement other Pharsight products, including Tria
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