MOUNTAIN VIEW, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Pharsight Corporation , a leading provider of software and strategic services for optimizing clinical drug development, announced today that it has signed a $265,000 agreement for regulatory population pharmacokinetics and pharmacodynamic analysis and reporting. The client is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases.
The project requires “regulatory compliance” in the data handling, analysis, and reporting performed by Pharsight’s Reporting and Analysis Services (RAS) unit. The project will be accomplished with the use of the Pharsight Knowledgebase Suite(TM) (PKS(TM)), which provides protected, structured storage, access and change tracking for project data, analyses and related files.
“With the growing emphasis on modeling and simulation advocated by FDA in the Critical Path Initiative, we are finding an increasing number of clients who expect strict regulatory compliance in the handling of their modeling and simulation projects,” said Shawn O’Connor, president, CEO, and chairman of Pharsight. “This project is significant not only because of its size, but also because we are delivering it in a regulatory-compliant way using our PKS data repository. PKS provides Pharsight clients the important benefits of electronic compliance. This means more of our professional time can go into generating superior modeling and simulation outputs. Pharsight is the only modeling and simulation provider having such an electronic repository. Thus in regulatory-quality projects we have an advantage over other providers who must rely on inefficient manual means to deliver compliant reports.”
This is the tenth, and largest, project that Pharsight has undertaken in its recently launched RAS unit. Clients have included a variety of large pharma and biotech companies. To support the growth in the RAS unit, Pharsight has increased its staff and facilities in Montreal.
About Pharsight Knowledgebase Server
Pharsight Knowledgebase Server(TM) (PKS(TM)) provides the technical infrastructure to effectively and securely manage pharmacokinetic/pharmacodynamic data and associated analyses across development programs or indications. With PKS, knowledge relating to both existing compounds and new chemical entities is captured, stored, managed, analyzed, summarized and reported in a secure, regulatory-compliant environment.
PKS provides protected, structured storage, access and change tracking for your data, analyses and related files. PKS is directly integrated with WinNonlin(R) Enterprise, Pharsight’s industry-leading PK/PD modeling and analysis tool. PKS also provides direct access to any ODBC-capable data source. In addition, PKS includes a desktop client to interface with SAS, NONMEM(R), S-PLUS(R) and SigmaPlot(R), and add-ins to manage Microsoft(R) Word and Excel documents. PKS can save file formats of any type (ASCII, JPG, DOC, etc.), to capture content from a wide variety of visualization and analysis tools.
About Pharsight Reporting and Analysis Services
Pharsight’s Reporting and Analysis Services (RAS) unit provides analysis and reporting for regulatory-oriented preclinical and clinical studies (Module 5 of the Common Technical Document). RAS is principally located in Montreal and serves all major drug development geographies, with business representatives in North America, Europe, and Japan.
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(R), Pharsight Knowledgebase Suite, PKS, WinNonlin, WinNonlin Enterprise are trademarks or registered trademarks of Pharsight Corporation. SAS, NONMEM, S-PLUS, SigmaPlot, Microsoft(R) Word, and Microsoft Excel are trademarks or registered trademarks of their respective holders.
Contacts: Investors: Douglas Sherk EVC Group 415-896-6820 or Jennifer Beugelmans EVC Group 646-201-5447 Media: Jennifer Saunders EVC Group 646-201-5431
Pharsight Corporation
CONTACT: investors, Douglas Sherk, +1-415-896-6820, or JenniferBeugelmans, +1-646-201-5447, or media, Jennifer Saunders, +1-646-201-5431,all of EVC Group for Pharsight Corporation
Web site: http://www.pharsight.com/
