PharmaNet Development Group Announces Release of PharmaSoft(R) 2007
29 March 2007 - 10:45PM
Business Wire
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.
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