Navigation Links
Pharsight's Reporting and Analysis Services Business Unit to Leverage New Validated Data Management System

Pharsight's Regulatory-Oriented Consulting Unit to Use Pharsight Knowledgebase Server for Management of Pre-Clinical and Clinical Data

MOUNTAIN VIEW, Calif., Feb. 28 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that its Reporting and Analysis Services (RAS) group has initiated use of a validated enterprise product for data management, PKS(TM) (Pharsight(R) Knowledgebase Server(TM)).

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(R), WinNonlin AutoPilot(TM), and now Pharsight(R) Knowledgebase Server(TM) (PKS(TM)). 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(R), and SAS(R), and data import from leading clinical data management and laboratory information management systems such as Watson LIMS(TM). PKS software is designed to complement other Pharsight products, including Trial Simulator(TM) and Drug Model Explorer(R) (DMX(R)), 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 .

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 February 14, 2008. 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, WinNonlin AutoPilot, Pharsight Knowledgebase Server, Drug Model Explorer, DMX, Trial Simulator, and PKS, are registered trademarks or trademarks of Pharsight Corporation. All other brand or product names mentioned in this document are trademarks or registered trademarks of their respective holders.

SOURCE Pharsight Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. BIO-key(R) Awarded Contract to Deploy Incident Reporting System for Littleton, CO Police Department
2. American Oriental Bioengineering Announces Reporting Date for Third Quarter 2007 Financial Results
3. Pharsights Reporting and Analysis Services Business Reaches Quality Assurance Milestone
4. BioNanomatrix Announces Issuance of Key Nanofluidics Patent Enabling Single Molecule Whole Genome Analysis
5. SeqWright Unveils ABI SOLiD(TM) Next Generation Genetic Analysis System
6. Topline Findings from Comparative Analysis of INVEGA(TM) and Quetiapine in Schizophrenia to be Postered at the 20th Annual U.S. Psychiatric and Mental Health Congress
7. Massive reanalysis of genome data solves case of the lethal genes
8. ARRIVE Registry Analysis Demonstrates Continued Safety and Efficacy of TAXUS(R) Stent in Complex Real-World Patients
9. Gene Codes Corporation Announces Version 4.8 of Sequencher Software for DNA Sequence Assembly & Analysis
10. Center for Molecular Medicine Selected to Provide DNA Analysis for Childrens Oncology Group Leukemia Study
11. Credit-card-sized platform for volatile compound analysis CAREER project goal
Post Your Comments:
(Date:11/30/2015)... , Dec. 1, 2015 /PRNewswire/ - BioAmber Inc. (NYSE: BIOA ... has joined the American Business Act on Climate Pledge, alongside ... are standing with the Obama Administration to demonstrate an ongoing ... strong outcome to the COP21 Paris ... --> Sarnia, Canada . --> ...
(Date:11/30/2015)... , Nov. 30, 2015  Culprits beware, ... assistant chemistry professor Jan Halámek, is taking crime ...   --> ...   --> --> ... UAlbany have discovered a straightforward concept for identifying ...
(Date:11/30/2015)... Nov. 30, 2015 /PRNewswire/ - Zenith Epigenetics Corp. ("Zenith" or ... Norman C.W. Wong to its Board of Directors to ... Zenith with a wealth of experience as co-founder of Resverlogix, ... --> --> Dr. Wong ... board of directors. Zenith,s long standing expertise in epigenetics and ...
(Date:11/30/2015)... Atlanta, GA (PRWEB) , ... November 30, 2015 ... ... announced a new globally touring exhibition Jurassic World: The Exhibition, opening in March ... Exhibition will embark on a worldwide tour including several North American tour dates. ...
Breaking Biology Technology:
(Date:11/20/2015)... 2015 NXTD ) ("NXT-ID" or ... growing mobile commerce market and creator of the Wocket® ... was recently interviewed on The RedChip Money Report ... weekend on Bloomberg Europe , Bloomberg Asia, Bloomberg ... NXTD ) ("NXT-ID" or the "Company"), a biometric ...
(Date:11/19/2015)... YORK , Nov. 19, 2015  Although some ... market is dominated by a few companies, according to ... companies own 51% of the market share of the ... The World Market for Molecular Diagnostic s ... "The market is still controlled by one company ...
(Date:11/18/2015)... New York , November 18, 2015 ... Market Research has published a new market report titled ... Growth, Trends, and Forecast, 2015 - 2021. According to the ... in 2014 and is anticipated to reach US$29.1 bn ... to 2021. North America ...
Breaking Biology News(10 mins):