Global Deployment of Pharsight's Automated PK/PD Data Management and
MOUNTAIN VIEW, Calif., Feb. 26 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software and strategic services for optimizing clinical drug development, today announced that a top Japanese-based pharmaceutical company has purchased a clinical data management and reporting solution including Pharsight(R) Knowledgebase Server(TM) (PKS(TM)), WinNonlin(R) AutoPilot(TM), and PKS Reporter(TM). This sale marks the first sale of an enterprise solution through Pharsight's Japanese distributor CTC Laboratory Systems and the fourth new customer for WinNonlin AutoPilot since the product's release in June of last year. This new agreement brings Pharsight's total number of PKS customers to 22 and is the fourth sale to a Japanese Top 50 pharmaceutical firm.
By integrating PKS, WinNonlin AutoPilot, and PKS Reporter into one PK data management and reporting solution, customers benefit from the power of standardized and regulatory-compliant data handling and the efficiency of automation of common or repetitive tasks during clinical pharmacokinetic (PK) analysis. By using WinNonlin AutoPilot to create report-ready tables and graphs and PKS Reporter to finalize reports and to manage report updates, companies can vastly increase their productivity while improving the quality and consistency of analyses and reports.
"This purchase illustrates the success of our Japanese partners from CTC. It also demonstrates the need for global drug development organizations to achieve higher productivity and regulatory-compliant PK workflows that are enabled by our innovative tools," said Shawn O'Connor, president, chief executive officer and chairman of Pharsight. "The flexibility of PKS and AutoPilot allows clients to configure their solution to meet the needs of their PK analysis workflow and to efficiently produce the type of reports mandated by regulatory authorities. The potential productivity gains from automating this work are large, with the ability to reduce the labor required to generate these outputs by 80% in some cases. We believe clients will continue to invest in our market-leading software products because they offer a tangible return on investment as well as a proven pathway to more efficient drug development."
The Pharsight Knowledgebase Server (PKS) is a high productivity, regulatory-compliant enterprise data management system. PKS is now installed in over 20 major pharmaceutical and biotechnology companies and also at FDA in connection with an extensive Pharsight FDA Cooperative Research and Development Agreement. PKS enables pharmaceutical and biopharmaceutical companies to better manage and control preclinical and clinical kinetic and dynamic data and analyses. Companies use PKS to build pharmacokinetic and pharmacodynamic (PK/PD) data management architecture compliant with FDA regulation 21 CFR Part 11, which has set new standards for computer system validation and usage. The PKS software is designed to complement Pharsight's modeling and simulation technology for computer-based drug disease modeling and clinical trial simulation. PKS supports analysis in leading tools such as WinNonlin(R), NONMEM(R), and SAS(R) as well as connectivity to LIMS such as Watson LIMS.
About WinNonlin AutoPilot
WinNonlin AutoPilot orchestrates PK analyses by selecting input data from a user's local file system or PKS, and then directs WinNonlin(R) to perform analyses and produce report quality tables, figures, and text output (e.g., in Microsoft (R) Excel, SigmaPlot(R), and Microsoft(R) Word) for regulatory submissions and interim reports. Formatted PK analyses outputs must reflect the requirements and SOPs of each research organization, and WinNonlin AutoPilot provides a user interface that allows extensive configuration of formatting and business rules to enable clear communication of standards and immediate use across the organization. PK analyses that can be automated include noncompartmental analysis for different study designs and inferential statistics (e.g., bioequivalence testing), as well as comparisons between analytes, dose routes or other conditions.
Used in conjunction with PKS and PKS Reporter(TM), WinNonlin AutoPilot provides standardized, regulatory compliant, secure and automatic generation of routine analyses and reports. Used independently of PKS and PKS Reporter, WinNonlin AutoPilot can provide significant return on investment through productivity gains and quality improvements in PK analysis and reporting.
About PKS Reporter
PKS Reporter addresses the need for streamlined, systematic, and automated report generation and signature. Using the Pharsight Knowledgebase Server (PKS) as an underlying source of secure, regulatory-compliant report content, PKS Reporter allows researchers to use familiar tools such as WinNonlin and Microsoft Word(R) to construct, update, review and approve any type of report. PKS Reporter is directly integrated with PKS, as both a source of report content and a secure repository for report storage and version control. PKS Reporter links reports in Microsoft Word directly to PKS, where it draws report content from data and modeling results created in WinNonlin Enterprise, NONMEM, SAS and other industry-standard modeling and analysis tools. From within Microsoft Word, researchers can browse the PKS database, loading objects and values drawn from various PKS studies and analysis scenarios. When the source data change, PKS Reporter marks its content as out of date, ready for automatic update. QA staff can automate the verification of report data by simply opening the document and selecting to have all references checked. Users can create standardized report templates specifying report layout, formatting and specific content elements. Report signoff is smooth and automatically tracked with Reporter's signature tool and email notification.
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 Corporation is headquartered in Mountain View, California. Information about Pharsight is available at http://www.pharsight.com.
Forward Looking Statements
The statements in this press release related to the performance of Pharsight products are forward looking statements. Forward looking statements are inherently speculative, and actual results may differ materially from Pharsight's expectations due to a variety of factors, including: changes in FDA regulations may affect the demand for the product. and customers may not perceive the benefits of the product to be the same as Pharsight believes them to be. Other risk factors relating to Pharsight are disclosed in the company's most recent Form 10Q filed with the Securities and Exchange Commission on November 9, 2007. All forward looking statements are based on information available to the company on the date hereof, and the company assumes no obligation to update such statements.
Registered Trademarks and Trademarks
Pharsight, Pharsight Knowledgebase Server, PKS, WinNonlin AutoPilot, PKS Reporter and WinNonlin are trademarks or registered trademarks of Pharsight Corporation. NONMEM, Word, Excel, Watson, and SAS are trademarks or registered trademarks of their respective holders.
|SOURCE Pharsight Corporation|
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