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
|SOURCE Pharsight Corporation|
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