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PharmaNet Development Group, Inc. is launching two technology platforms—Initiator™ and PKS™— to accelerate data acquisition and the processing of final client reports in its Phase I clinics.
With the launch of these two new technology platforms, PharmaNet aims to provide rapid data handling, and eliminate potential transcription errors, as data is processed through different software tools. The data can be verified online and real-time information about the clinical study can be obtained in validated systems that provide the necessary audit trail features and compliance with 21CFR Part 11 standards.
"The investments in Initiator and PKS will help us to accelerate the availability of data to our clients and will help to further improve data integrity," said Riaz Bandali, President, Early Stage Development.
During 2010, the Company made significant investments in the implementation of PKS™, WinNonlin® and WinNonlin® Autopilot™, a complete PK/PD data management and reporting solution. This suite of products, provided by Pharsight, is used by several major pharmaceutical companies. This centralized data repository houses all PK/PD data, analysis and objects related to a study and seamlessly interfaces with the Company's laboratory information system and other CDISC formatted data sources. Final PK/PD data and analysis are flexibly produced in standard or customized reports.
PharmaNet has also implemented Initiator™, a software system built for the conduct of Phase I studies. The implementation of this platform enables rapid study set-up, automated CRF generation, and enhanced study recruitment and communication tools for general and special populations. Mobile workstations allow for rapid data entry and data is captured directly using bar codes and interfaces to medical equipment, such as blood pressure monitors. The Initiator platform also interfaces with the Company's LIMS, as well as its diagnostic laboratory software and investigational drug management system.