Pharmanet Development Grp (MM) (NASDAQ:PDGI)
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PharmaNet Development Group, Inc. (NASDAQ: PDGI) today announced the
release of PharmaSoft® 2007 which provides new
data capture, monitoring, cleaning and management enhancements to its
clinical trial data management software.
PharmaSoft 2007 is based on a new platform architecture that improves
system performance, supports multiple application environments and is
completely independent of server operating systems. The software
enhancements include improved scalability, a new edit-check validation
tool, new copy/paste protocol configuration elements that allow for the
rapid set-up of new studies, advanced search functionality to facilitate
customized data mining and ad hoc queries and improved visibility of the
clinical report form audit trail.
The PharmaSoft suite of software tools provides a complete solution to
streamline entry and management of the large amount of data associated
with clinical trials without using multiple tools or application
environments. Its features include:
Clinical Data Management (CDM) and Clinical Trial Management System
(CTMS)
Integral Electronic Data Capture (EDC),
Easy to implement and an easy-to-follow, intuitive structure that
minimizes the need for training at clinical investigator sites,
Capable of supporting a wide variety of study organizations in
addition to the traditional site, subject, visit, page structure,
Accommodates hybrid study environments where data is being entered
using both electronic and paper Case Report Forms (CRFs),
Fully compliant with 21CFR Part 11 for electronic signatures and GCP,
Features include a scalable flexible architecture, tools for extensive
coding and reporting, and extraneous data import capabilities from
central laboratory, Interactive Voice Response System (IVRS),
electronic subject diaries, etc.
Global multi-lingual helpdesk support.
PharmaSoft provides a complete solution for capturing, verifying and
managing the data associated with clinical trials. PharmaSoft solutions
incorporate the real-world expertise of PharmaNet Development Group
professionals in clinical research, data management, project management,
information technology, and software development. It has been used for
more than seven years on clinical trials of all scales and complexity.
The PharmaSoft suite of clinical trial software technologies consists of
integral modules including:
WebSys® is an easy-to-use, web-based
EDC and CDM system for collecting and managing clinical trial data.
Customized screens ease entry of CRF data. With system set-up
segregated from the study, changes can be modeled and assessed before
updating the clinical trial database.
PROMIS™ is a flexible CTMS that helps
manage critical study information such as investigator site data, site
monitoring visit history and reports, study start-up documents, and
regulatory/Independent Review Board (IRB) approvals. Its structure is
completely flexible to accommodate the needs of each study.
FaxSys™ features a facsimile data
capture system that reads, verifies, saves the original fax and then
uploads the data into the WebSys module. When appropriate, FaxSys can
be utilized in conjunction with WebSys in one and the same study.
TeleSys™ is an IVRS that provides
functionality for subject randomization, and manages drug and
laboratory kits supplies as well as subject diary information. TeleSys
has been fully integrated with WebSys, providing an automated
bi-directional exchange of data between the two systems.
For more information about PharmaSoft, please visit www.pharmasoft.com
or contact Francis Wouters, D.D.S., Ph.D. at 919-465-4700 or via e-mail
at fwouters@pharmanet.com.
About PharmaNet Development Group,
Inc.
PharmaNet Development Group, a global, drug development company,
provides a comprehensive range of services to the pharmaceutical,
biotechnology, generic drug, and medical device industries. The Company
offers clinical-development solutions including early and late stage
consulting services, Phase l clinical studies and bioanalytical
analyses, and Phase Il, III and IV clinical development programs. With
approximately 2,200 employees and more than 35 facilities throughout the
world, PharmaNet is a recognized leader in outsourced clinical
development. For more information, please visit our website at www.pharmanet.com.