PDGI Pharmanet Development Grp (MM)

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.