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58 A ug u s t 20 03 PharmaVOICE EMEDIA NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES EDocCompliance for the Oracle platform, recently launched by Qumas, is a readytovalidate, Web based application that manages the full life cycle of regulatorycontrolled documentation without the need for customization. The application manages the full life cycle of regula tory controlled documentation in compliance with FDA (including 21 CFR Part 11), EMEA, ISO, and other international regulations. EDocCompliance incorporates the latest Web technology, including J2EE, to facilitate the electronic Thomson CenterWatch and NCERx Service Provides CLINICALTRIAL INVITATIONS to Research Volunteers Thomson CenterWatchandNCERx have established the Volunteers Direct Network,a collaborative Internetbased service for patients interested in par ticipating in clinical research studies.The service, volunteersdirect.net, reaches a large and highly motivated group of patients with targeted invitations for them to participate in diseasespecific clinical trials.The new service also assists clinicalresearch professionals in augmenting their subject recruitment efforts. “Looking at the evolution of the biotechnology and pharmaceutical industry over the next five years,we see the rate of discovery accelerating the need for ever more targeted candidates for trials of increasingly specialized compounds and chemical entities,” says Colin LucasMudd, president and CEO of NCERx. “We are delighted to be collaborating with CenterWatch, the clinicaltrial market leader.The Volunteers Direct Network is a first step in a collaboration that addresses clinicaltrial recruitment needs in this dynamic research environment.” The Volunteers Direct Network provides access to CenterWatch clinical trial listings on the NCERx lifestyle and healthcare network. Currently, the NCERx network receives more than 10 million monthly visitors seeking healthspecific information.The proprietary NCERx platform includes protocolspecific filtration,messaging,and online screening components.Research sponsors, CROs,and investigative sites can use this large and growing network to direct prospective volunteers to newly initiated and ongoing clinical trial descriptions maintained by CenterWatch. Use of the Volunteers Direct Network is available exclusively to clinical research professionals through CenterWatch. routing, review, approval, and archival of regulatory documents. Theapplication integrates with exist ing technology infrastructures and the entire suite of Qumas Enterprise Compliance Management solutions. EDocCompliance features full administrative functionality, an enhanced audit trail, and critical compliance management features. In addition, the company has released QumasVisa to help pharma ceutical, medicaldevice, and biotechnology corpora tions comply with the latest international regulations. Qumas Introduces LifeSciences RepositoryNeutral COMPLIANCE SOLUTION MedManage/MD Consult Partnership HELPS PHARMACEUTICAL CUSTOMERS With DrugSample Program MedManage Systems and MD Consult have partnered to link physicians and pharmaceutical companies using MedManage’s eMedSample Online Drug Sampling Platform. MD Consult is expanding its physician services by providing its com munity of 285,000 physicians and other healthcare professionals with easy, online access to prescription drug samples and related information powered by MedManage.Based on the options defined by pharmaceutical compa nies, qualifying physicians are able to request and obtain specified quantities of samples for delivery via mail, by pharmaceutical repre sentatives, or by downloading sam ple vouchers. MD Consult subscribers have complimentary access to the Med Manage eMedSample Platform through MD Consult’s Clinical Knowledge System, an integrated family of online medical informa tion services. More than 1,000 healthcare organizations and more than 90% of North American med ical schools license the service. The solution includes physician targeting and recruitment services, alternative drug sampling systems, andmarketing informatics services. The solution captures data on the frequency and manner in which physicians use the platform,as well as promotional response analytics and ROI analyses. Bill Haines, VP of product development and marketing for MD Consult, says busy physicians now have easier access to the drug information and samples they want. “Looking at the evolution of the biotechnology and pharmaceutical industry over the next five years, we see the rate of discovery accelerating the need for ever more targeted candidates for trials of increasingly specialized compounds and chemical entities,” says Colin LucasMudd. First Consulting Group’s FIRSTDOCMEDINFOSTREAMLINES LIFESCIENCES COMPANIES’RESPONSES to ProductRelated Inquiries First Consulting Group’s FirstDoc MedInfo centralizes and streamlines the critical task of responding to prod uctrelated inquiries for lifesciences and biopharmaceutical companies.FirstDocMedInfo provides anendtoend customer relationship management answer to manual processes of medical information services departments. FirstDoc MedInfo integrates the company’s domain knowledge with the technologies of Siebel and Docu mentum, leaders in call center and content management.Medicalinformation services departments can capture inquiries, build responses, and distribute them efficiently, while complying with federal and global regulatory requirements. The product’s features include quick automatic response identification and assembly based on inquiry information and seamless automatic distribution of the response via email, fax, or mail; reference manage ment that links standard responses to internal study reports and/or external journal articles; workflow that auto mates the review and approval process; ondemand and scheduled management reporting;automatic assign ment based on workload within the medical information services department and triaging of adverse events to pharmacovigilance;optional healthcare professional selfservice Website;and online help and enduser training. The application manages the full life cycle of regulatory controlled documentation in compliance with FDA regulations. Emedia 59 PharmaVOICE A ug u s t 20 03 Thomson PDR has entered into agreements with four leading global pharmaceutical compa nies to manage its product labeling submissions with the Webbased PDRxpress system. Launched in June 2002, PDRxpress permits online submission and management of official drug product labeling that PDR collects, maintains, and disseminates in both print and electronic formats. When pharmaceutical manufacturers electroni cally submit new product labeling and labeling updates using PDRxpress, the information is refor mattedexactly as it will appear in PDR and posted on a secure Website for the manufacturer’s review and final approval.The approvedentries are thenavailable for electronic distribution via pdr.net and PDRonCD ROM.Printed versions of the entries will appear in the annual edition of PDR and its supplements. plete history of changes in their labeling.” PDRxpress also is designed to accommodate recently pro posed amendments to the reg ulations governing the format in which pharmaceutical compa nies submit product labeling to the Food and Drug Administra tion. Under the amended regu lations, electronic copies of the labeling in PDF format must accompany new drug applica tions, biological license applica tions, abbreviated new drug applications, supplements, and annual reports. QUOVADXTOOLSET Helps Companies Cut Development Cycles, Increase Productivity, and Eliminate Errors Quovadx Inc. has introduced its Life Sciences Adaptive Framework,which can help pharmaceutical organizations to shorten development cycles, quickly respond to new business requirements, comply with government mandates, and leverage and extend existing systems. The framework is a set of reusable interoperable components that complement its busi ness process management and integration platform, QDX Platform V. This flexible approach is expected to result in faster timetomarketas well as reduced train ing time, support costs,and likelihood of error. “The proven components that comprise our framework deliver tangible bottomline results, including improved process compliance and docu mentation, expedited task completion, and increased staff productivity,” says Dr. Ken Macrae, senior VP and chief medical officer at Quovadx. The Life Sciences Adaptive Frameworkconsists of a suite of core components that organizations can reuse to get up and running quickly, enhancing return on technology investment. For example, role based access control ensures security by providing access to specific systems and data based on an indi vidual’s role.Government mandated features support 21 CFR Part 11 and HIPAA compliance. Personalized and dynamically updated action and todo lists, basedonautomated standard operating procedures, ensure processes are completed according to orga nizational guidelines. Automated escalation provides functionality to keep projects on track and eliminate roadblocks that can impede completion through a succession of customizable alerts, reminders, and action steps. PDRxpress also is a key element in a paperless labeling system that Thomson PDR has proposed at the request of a special task force within Pharma ceutical Research and Manufacturers of America. The system is designed to electronically deliver the most current drug labeling to every dispensing site in the United States and its territories. Following an alpha test in 2002,Thomson Healthcare emerged as one of two finalists to establish such a system. “Ultimately PDRxpress will provide an endto end XMLbased solution for the electronic manage ment and delivery of the latest prescribing informa tion to healthcare professionals,”says Mukesh Mehta, VP for Thomson PDR. “Pharmaceutical companies will upload their labeling documents in XML. PDRx press will maintain an archive of each document and provide each participating company with a com Major Pharmaceutical Companies Adopt Thomson PDR WEBBASED INFORMATION MANAGEMENT SYSTEM FOR LABELING FIRST CONSULTINGGROUP INC., Long Beach,Calif., is a leading provider of consulting, technology, applied research, IT, and businessprocess outsourcing services for healthcare,pharmaceutical, and other lifesciences organizations throughout North America, Europe,and Asia.For more information, visit fcg.com. MDCONSULT,St.Louis,helps physicians answer clinical questions and stay abreast of recent developments online.MD Consult is a part of health science publisher, Elsevier. For more information, visit mdconsult.com. MEDMANAGE SYSTEMS INC.,Bothell, Wash.,offers comprehensive prescription drugsampling solutions for the pharmaceutical industry. For more information,visit medmanagesystems.com. NCERX LLC, Oceanside,Calif., is a healthcare information technology company providing a unified solution for clinicaltrial recruitment,consumer messaging,and market research needs to the pharmaceutical and biotechnology sector.For more information,visit ncerx.com. QUMAS,Florham Park,N.J., and Cork, Ireland, develops,markets,and supports a suite of integrated compliance management products designed to help lifesciences companies ensure regulatory compliance. For more information,visit qumas.com. QUOVADX INC., Englewood,Colo.,provides endtoend business infrastructure software and services,including consulting, transaction hosting, and operations management for businesscritical applications.For more information,visit quovadx.com. THOMSON CENTERWATCH,Boston,a business unit of TheThomson Corp., is a publishing and information services company that provides business journalism, reference databases,accredited training manuals,original research and analysis,and market intelligence services to assist organizations in managing and implementing clinical research strategies and operational initiatives. For more information,visit centerwatch.com. THOMSON PDR,Stamford,Conn.,part of TheThomson Corp.,publishes The Physicians’ Desk Reference,as well as several other annual titles and offers numerous professional educational program sponsorship opportunities to the pharmaceutical industry.For more information, visit thomson.com. Mukesh Mehta says PDRxpress provides an endtoend XMLbased solution for the electronic management and delivery of the latest prescribing information to healthcare professionals. Follow up