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November 2003E-media MDS Pharma Express is intuitive, user-friendly, and designed to operate with minimal computer requirements and the highest level of Internet security –providing easy access to current study status information in real time, anytime. MDS Electronic Data-Delivery System Allows for Real-Time, Late-Stage, Clinical-Trials Management MDS Pharma Services, a provider of innovative drug-discovery and development solutions, has introduced MDS Pharma Express, a service that provides sponsors with real-time access to their clinical-trial management data via a customized, secure, Web-based interface. According to Alan Horgan, group VP, late-stage development of MDS Pharma, the service makes it possible to access investigator and subject summary information, including drill-down features and hyperlinks to such data as print-ready reports on study status and site visits as well as site visit schedules. Screen zones, or portlets, retrieve live study status information from MDS Pharma Services’ in-house, proprietary operational databases, which are automatically published on a systematic time schedule through MDS Pharma Express’ Web interface. The benefits of MDS Pharma Express include the ability to monitor project status and activity and view contact reports through a single portal; track and promote critical milestones and share key information; provide unlimited, sponsor-authorized user access; facilitate the administration and communication of significant amounts of information transferred each day; enhance clients’ global and local studies with its global data management capabilities; customize reports to project-specific requirements; and access a shared file exchange and post forms, newsletters, or other documents. MDS Pharma Express is intuitive, user-friendly, and designed to operate with minimal computer requirements and the highest level of Internet security –providing easy access to current study status information in real time, anytime. PHT Launches Service for Electronic Patient Diary Deployment PHT Corp.’s Trial Success Program (TSP) is a new best-practices-based service that provides sponsors with expert guidance in deploying electronic patient diary (EPD) solutions. TSP was developed using PHT’s experience in deploying its technology in more than 75 clinical trials globally. TSP provides support and guidance to clinical-trial sponsors through the study setup, study deployment, study tracking, and study closeout stages of each EPD trial. The program provides sponsors with a clear roadmap to success when adopting EPD and other electronic patient reported outcome (ePRO) solutions in clinical trials. “In our work with our customers, we’ve heard a clear need for a systematic, best-practices approach to EPD study deployment,” says Philip Lee, president and CEO of PHT. “TSP was developed from our years of experience deploying successful EPD solutions in clinical trials across various patient populations and medical indications.” “The benefits of TSP to sponsors are substantial,” says Gail Browder, executive VP and president, products and services, at PHT. “We have significantly reduced time to trial deployment to four weeks, down from an industry average of 12 weeks. Our standardized approach to trial deployment means sponsors know from the kick-off meeting through to study close out exactly what to expect.” Philip Lee According to Philip Lee, PHT’s president and CEO, the Trial Success Program meets the industry’s need for a systematic, best-practices approach to electronic patient diary study deployment. Medsite’s Online Detailing Solution Offers PhRMA Compliance and Increases ROI for Pharmaceutical Marketers Medsite’s recently launched iDetailing technology maximizes the efforts of pharmaceutical marketers by increasing physician response rates and providing measurable results. The physician-centric resource increases marketing effectiveness since customized content is tailored to physicians’ needs and practice patterns. The solution’s technology incorporates proprietary targeting and segmentation methodology to deliver messages to the appropriate audience and provides marketers with tangible metrics indicating response ratios. iDetailing also provides clients with in-depth metric analyses on the total reach of each detail. Marketing managers have access to an extranet that provides real-time metrics, including number of physicians detailed, their relative segments, percentage of responses to comprehension and market-research questions, as well as time-tracking of each detail accessed. The enhanced detailing solution profiles physician response rates and provides feedback on each product’s most compelling sales messages. An ongoing, collaborative analysis measures physician prescribing behavior before and after the program and helps clients determine uptake. Medsite clients can further increase ROI by hosting multiple iDetails on the company’s Promotion Platform, which is a scalable, robust application that can be customized to meet any requirements. The Medsite Promotional Platform also reduces the cost-per-detail and enables cross-promotion among brands and product lines. “Medsite works closely with pharmaceutical brand managers and marketers to ensure complete customization of each detail, based upon product messaging, positioning, regulatory guidelines, and business objectives,” says Sundeep Bhan, president and CEO of Medsite. Physicians gain valuable scientific and educational benefits by learning about specific products in an efficient, online environment. The new detailing solution also enables pharmaceutical manufacturers to meet the disclosure requirements of various states as well as comply with the PhRMA code and OIG regulatory guidelines. Medsite can arrange for product samples to be distributed to participating physicians, by partnering with reliable vendors. iDetailing can be used with Medsite Rewards, the company’s flagship honorarium program. Sundeep Bhan Medsite’s interactive details yield significant, measurable ROI and are customized to comply with the current PhRMA Code and OIG regulatory guidelines. Electronic Laboratory Solution for Researchers Launched by GenSys GenSys/ELN, an enterprise-ready electronic laboratory solution for research-intensive organizations, has been introduced by GenSys Software Inc. Based on extensive customer research and testing, GenSys/ELN delivers advances in productivity, integration, collaboration, and security, including an open, scalable architecture providing seamless integration of existing desktop tools and back-end applications; the category’s most advanced interface proven to significantly boost researcher productivity; and an unparalleled scope of collaboration, search, and security features. GenSys/ELN is an enterprise solution built on open database standards, Web services, and enterprise applications from technology partners such as Oracle, Sun Microsystems, and BEA Systems. The user benefits of this platform approach are immediate integration of all existing work tools, complete system access flexibility, and robust performance as the system is expanded throughout the enterprise. GenSys/ELN addresses the needs of entire R&D organizations, including legal, regulatory, quality assurance, and records management professionals “The first priority for customers is a solution that works at an enterprise level and seamlessly integrates with their existing desktop and back-end systems,” says Tom Williams, CEO of GenSys. “We specifically designed the GenSys/ELN as a platform solution to preserve existing IT investments and summarily eliminate the inefficiencies and integration headaches created by islands of automation.” GenSys/ELN also includes a number of built-in, productivity-boosting chemistry tools aimed at reducing time spent on tedious experiment-building tasks. GenSys/ELN lets researchers quickly drag and drop common reaction file formats into the interface and have all reaction specific information added to the notebook entry automatically. Researchers can draw clean stoichiometric grids with push-button simplicity. GenSys/ELN also has embedded stoichiometry formulas so that any value can be adjusted at the same time other values are automatically updated. “Our clients have shown us that a 10% increase in productivity gained by using our tools in an organization with just 150 researchers translates to almost $4 million in annual savings,” Mr. Williams says. “That’s the simple return on investment. More significant savings come from enhanced collaboration and a huge reduction in reproduced research.” Tom Williams Considering more than 20% of most research professionals’ time is used recording data in composition books today, GenSys/ELN can impact R&D productivity. NetRegulus Utility Alerts Life-Sciences Companies to Data-Management Problems NetRegulus recently released an addition to its v6 product line, AlertExpert, which provides life-sciences customers with more flexibility in examining their data and defining appropriate actions, depending on these findings. NetRegulus v6 is a regulatory software system that provides enterprisewide, Web- and Windows-based data management specifically for the life-sciences industry. AlertExpert lets users monitor and delimit data results gathered by ad-hoc queries to the v6 database at predefined intervals. “AlertExpert gives customers an added margin of safety, automates a problem-prone business process, and adds enriching detail to the database,” says Mark Schaub, CEO of NetRegulus. With AlertExpert, users do not need special programming tools to establish thresholds for any situation or set of conditions; add user-definable actions, including sending e-mails, creating automatic issues, triggering alerts, generating trending records, and producing site data-clarification requests; and preserve and attach various types of data to be used for documentation. Designed to work across all business-process solutions encompassed by NetRegulus v6, AlertExpert provides users with an easy way to manage and monitor product quality. AlertExpert enables users to establish corrective and preventive action checks; generate new quality issues, tasks, and/or investigations associated with predefined conditions; identify and analyze quality trends; automatically alert key personnel in the complaints, nonconformance, or audit areas when special conditions exist; and monitor the performance of suppliers and vendors with regard to incoming materials. For users whose primary application is study-data management, AlertExpert helps manage business processes because it automatically scans data for study-specific conditions and takes appropriate user-defined actions if and when a given condition occurs. The AlertExpert utility also quickly and automatically identifies a variety of critical data conditions, including missing data values, possible extreme data points (outliers), and event occurrences in excess of specified threshold values. Mark Schaub AlertExpert is aptly named because it automatically keeps track of — and takes action on — so many details and potential problem events that manual methods could overlook. Follow up GenSys Software Inc., Santa Monica, Calif., is a global provider of innovative enterprise software solutions for life- sciences, chemical, and research-intensive organizations. For more information, visit gensys.com. MDS Pharma Services, Lincoln, Neb., part of MDS Inc., offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. For more information, visit mdsps.com. Medsite, New York, uses the power of the Internet to provide a full suite of online marketing and educational services that broaden reach, cement relationships, and deliver rewards to physicians. For more information, visit medsite.com. NetRegulus, Oakbrook Terrace, Ill., is a privately held company that has pioneered software solutions for clinical, quality, and regulatory data management for the life-sciences industry. For more information, visit netregulus.com. PHT Corp., Charlestown, Mass., is a global provider of electronic patient reported outcome solutions for companies that must collect conclusive clinical-trial data. For more information, visit phtcorp.com.