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PharmaNet Development Group Announces Release of PharmaSoft(R) 2007.


PRINCETON, N.J. -- PharmaNet Development Group, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: PDGI PDGI PharmaNet Development Group, Inc. ) today announced the release of PharmaSoft[R] 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 1. CDM - Content Data Model
2. CDM - Code Division Multiplexing
) and Clinical Trial Management System (CTMS CTMS Clinical Trial Management System
CTMS California Traditional Music Society
CTMS Container Terminal Management System
CTMS Clinical Trials Management Software
CTMS Carrier Transmission Measuring System
CTMS Constrained Tree Migration Scheme
)

* Integral Electronic Data Capture (EDC EDC

See: Export Development Corp.
),

* 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 CFR

See: Cost and Freight
 Part 11 for electronic signatures and GCP GCP Good Clinical Practice
GCP Ground Control Point
GCP Global Carbon Project
GCP Gateway Control Protocol
GCP Global Consciousness Project
GCP Granulocyte Chemotactic Protein
GCP Grand Central Parkway (New York) 
,

* 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 IVRS Interactive Voice Response System
IVRS Iowa Vocational Rehabilitation Services
IVRS Ironside Volunteer Rescue Squad (Maryland) 
), 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[R] is an easy-to-use, web-based EDC and CDM system for collecting and managing clinical trial data. Customized screens ease entry of CRF CRF
abbr.
chronic renal failure


CRF Chronic renal failure
 data. With system set-up segregated from the study, changes can be modeled and assessed before updating the clinical trial database.

* PROMIS PROMIS Project Management Information System
PROMIS Prosecutor's Management Information System
PROMIS Patient-Reported Outcomes Measurement Information System
ProMIS Property Management Information System
PROMIS Procurement Management Information System
[TM] 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 IRB

See: Industrial Revenue Bond
) approvals. Its structure is completely flexible to accommodate the needs of each study.

* FaxSys[TM] 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[TM] is an IVRS that provides functionality for subject randomization randomization (ranˈ·d·m , 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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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 29, 2007
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