New Consulting Unit Hosts Three Customer Audits, Continues Growth Strategy
That Leverages Pharsight's Industry-Leading Software Tools
MOUNTAIN VIEW, Calif., Dec. 20 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that three global biopharmaceutical companies have performed audits of its Reporting and Analysis Services (RAS) unit. The three global drug development organizations that have performed audits of the RAS unit's capabilities are a Top 50 pharmaceutical company, a mid-sized specialty pharmaceutical company, and a leading biotechnology company.
The audits covered RAS operating practices and procedures for study analysis and reporting, RAS facilities, and RAS technology infrastructure. The ability of the RAS unit to support customer quality assurance audits underscores the unit's recently expanded quality assurance capabilities, and reflects the establishment of its quality management infrastructure which expands the types of services RAS can provide to Pharsight customers.
The RAS unit provides pharmacokinetic/pharmacodynamic (PK/PD) analysis and reporting for preclinical and clinical studies, utilizing Pharsight's industry-leading modeling, data management and reporting software tools to provide timely, high-quality analyses supporting sponsors' new drug application submissions. To date RAS has signed consulting agreements for PK/PD analysis and reporting and for population pharmacokinetic modeling with more than 20 pharmaceutical and biotechnology companies.
Since its launch in May 2007, the RAS unit has implemented and validated Pharsight's WinNonlin(R) and WinNonlin AutoPilot(TM) software products to support efficient delivery of non-compartmental analysis and reporting. The RAS group has also more than tripled its staff, including the addition of a Quality Assurance Inspector, and has plans to expand its facilities in Montreal, Canada.
"These recent audits provided third-party evaluations of the ability of our RAS team to deliver quality work in compliance with customer and regulatory expectations, utilizing our market-leading software," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "Our RAS unit enables drug developers to meet their growing needs for timely PK/PD modeling. RAS uses our software such as WinNonlin and WinNonlin AutoPilot to deliver submission-quality reports quickly and efficiently. We have created an internal infrastructure that will allow us to take on additional client projects with similar regulatory compliance needs. We believe this infrastructure supports our RAS unit's ability to consistently meet the highest scientific standards, and positions the group to continue serving clients who expect regulatory compliance in the handling of their modeling and simulation projects."
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 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. Pharsight'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 and benefits of Pharsight consulting services and software 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 and customers may not perceive the benefits of Pharsight consulting services and software products 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 10-Q 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, WinNonlin, and WinNonlin AutoPilot are trademarks or registered trademarks of Pharsight Corporation. All other brand or product names mentioned in this documentation are trademarks or registered trademarks of their respective companies or organizations.
|SOURCE Pharsight Corporation|
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