Pharsight's Reporting And Analysis Services Business Unit To Leverage New Validated Data Management System

Pharsight Corporation, a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, recently announced that its Reporting and Analysis Services (RAS) group has initiated use of a validated enterprise product for data management, PKS Pharsight Knowledgebase Server.

Pharsight's scientists within the RAS business unit provide analysis and reporting for regulatory-oriented preclinical and clinical studies using Pharsight's leading PK/PD analysis and reporting technology including WinNonlin, WinNonlin AutoPilot, and now Pharsight Knowledgebase Server (PKS). The validation and implementation of PKS provides RAS with a secure, compliant, and globally-accessible storage place for their customers' PK/PD models and data sets and will expand the services that RAS can provide while increasing the efficiency and throughput of modeling, analysis, and reporting efforts. The PKS system that RAS will use has been validated and is compliant with 21 CFR Part 11 for the management of electronic records and electronic signatures.

"By using the electronic compliance features of PKS, Pharsight RAS greatly increases efficiency while reducing error rates," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "We believe our technology puts us in a position to compete favorably against contract research organizations (CROs) who use manual systems when the client requires timely and compliant PK/PD modeling. RAS already uses our software such as WinNonlin and WinNonlin AutoPilot to deliver submission-quality reports quickly and efficiently. By integrating PKS with WinNonlin and Autopilot in a validated solution, we can now achieve even higher levels of productivity."

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, and SAS, and data import from leading clinical data management and laboratory information management systems such as Watson LIMS. PKS software is designed to complement other Pharsight products, including Trial Simulator and Drug Model Explorer (DMX), which are used for computer-based drug-disease modeling, clinical trial simulation, and drug model visualization.

About Pharsight Corporation
Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. The company's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post approval marketing and use of pharmaceutical products. Pharsight's approach enhances the fundamental element of drug development success: strong decision making. By adopting the Pharsight approach, customers acquire a new decision making process with the potential to systematically improve every level and phase of their business and scientific processes. Pharsight is headquartered in Mountain View, California. Information about Pharsight is available at www.pharsight.com .

SOURCE: Pharsight Corporation