Pharsight Achieves 21st PKS(TM) Customer
MOUNTAIN VIEW, Calif., Jan. 2 /PRNewswire-FirstCall/ — Pharsight Corporation (Nasdaq: PHST), a leading provider of software and strategic services for optimizing clinical drug development, today announced that a global biopharmaceutical company has become its 21st PKS customer. In addition to the PKS purchase, the customer will upgrade its existing investment in WinNonlin(R) modeling software, build software connectors to Watson LIMS(TM) and SAS, and deploy PKS Reporter to build a more productive analysis and reporting solution for pharmacokinetic data that is also regulatory compliant.
“We are steadily building a base of customers that greatly value our end-to-end software modeling solutions to improve research and development productivity,” said Shawn O’Connor, president, chief executive officer, and chairman of Pharsight. “PKS enables drug developers to better manage and control large quantities of clinical trial data. The PKS infrastructure coupled with PKS Reporter, which allows users to construct, review and approve key regulatory-compliant reports, improves the efficiency of the development process. By building upon the initial investment in WinNonlin with the purchase of PKS and PKS Reporter, this customer will enable compliant and productive analyses, reporting and data management workflows. We believe the return-on-investment for PKS and our other software for modeling and simulation will support continued growth in our installed base over the long term. We also plan to continue to strategically expand our product portfolio, as we have done with WinNonlin AutoPilot(TM) and IVIVC Toolkit(TM) for WinNonlin, to serve the growing development needs of our customers, which should also have a positive impact on our long-term growth opportunities.”
About PKS
The Pharsight Knowledgebase Server (PKS) is a high-productivity, regulatory-compliant enterprise data management system. PKS is now installed in 21 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 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 sign-off is smooth and automatically tracked with Reporter’s signature tool and e-mail 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 .
Registered Trademarks and Trademarks
Pharsight, Pharsight Knowledgebase Server, PKS, 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.
