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New Electronic and Web-based Applications, Sites, and Technologies
IBM Introduces ePedigree System IBM has introduced a system that allows pharmaceutical companies to create an electronic certificate of authenticity, known as electronic pedigree or e-pedigrees, for every drug that passes through the supply chain. The offering allows all participants in the drug supply chain — manufacturers, distributors, pharmacies, and hospitals — secure and on-demand access to historical data on individual bottles or packages of medicine. The e-pedigree feature is a key capability of the new version of IBM’s WebSphere RFID Information Center (RFIDIC), a high-performance data repository that allows clients to efficiently manage and securely share information with trading partners to authenticate pharmaceuticals. The IBM offering is designed to manage and aggregate product serial numbers to enable processes in manufacturing plants, distribution centers, pharmacies, and hospitals. IBM’s e-pedigree feature allows clients to comply with new and emerging regulations such as those that will take effect in California in 2009 using either RFID, two-dimensional barcodes, or a combination of barcodes and RFID. The offering provides a flexible “track and trace” framework for generating e-pedigrees through standards-based EPC Information Services. By establishing ePedigree via EPCIS events and queries, clients will also be able to access key data elements to solve other business needs such as chargeback resolution and expiration management. IBM’s approach enables e-pedigree compliance without significant impact to the existing business processes and legacy IT systems. In addition to being fully compatible with the EPCIS standard, the product integrates with customer master data systems to provide additional business context using product, location, and supplier information. Our ePedigree system will help manufacturers, distributors, and pharmacies meet the regulatory requirements that will take effect in California Jan. 1, 2009, says Christian C. Clauss, Director, Sensor Information Management, IBM Software Group. MedConference Offers Web-based MedConference has launched an updated version of its Web event platform, MedConferenceLive. MCL 3.0 has been designed based on specific client feedback. MedConference has upgraded registration, set up, and reporting features. The look and feel of individual registration and login pages include client logos, color schemes, and links. The use of speaker video during events is another feature, and for events with more than one speaker, MCL 3.0 can enable the speaker’s name and photo to change on a slide-by-slide basis. The platform allows for speaker video to be broadcast during the event. In addition, MedConference offers individual user profiles to allow for better client control of restricted sites and registration pages and enables users to easily register for multiple events, while maintaining a single username and password. The text chat feature in the new version remains relatively similar to previous versions and now allows speakers to see the exact time a chat question or comment was submitted. The new version of text chat also lets speakers mark specific chat messages, making the questions easier to find for later reference. MCL 3.0 gives clients immediate access to post-event reports. At the conclusion of the event, all attendance, evaluations, polling responses and chat logs will be available for download in either Excel or XML formats. Event Platform MedConference has launched an updated version of its Web event platform, medconferencelive.com. Perceptive Informatics Releases Enhanced CTMS Technology Perceptive Informatics has released an enhanced version of its Impact clinical trial management system (CTMS) with improved site management and monitoring capabilities. The Impact software comprises several Web-based modules designed to deliver practical and tangible results, which are intended to decrease the time, cost, and risk associated with the development of new products. The software provides planning and tracking support for all aspects of a clinical trial. The tool also consolidates information from various collection points into a single source. The solution is scalable to support studies of all sizes ranging from large, multinational studies to single-center studies. The most recent version features an online and offline Web-based site management and monitoring module, called MySites. MySites offers 24/7/365 access from anywhere in the world, enabling work on all aspects of site management, including monitoring, milestone planning, issue resolution, and patient recruitment. The Impact software comprises several Web-based modules designed to deliver practical and tangible results. Dowden Offers Contextual Advertising Opportunities Dowden Health Media, in partnership with First Light ERA, has introduced editorially related advertising, available to Dowden clients. Through new online technology, clients can place their marketing message immediately adjacent to online editorial content that is relevant to their brand. Ads are placed in a “content from related companies” box to the right of an editorially related article. The client controls the text within the box, which links to a microsite containing up to 30 pages of content. Clients can create lead generation forms directly onsite and access real-time reporting that will allow them to evaluate activity levels on their microsites, as well as to compare them with others in their sector. “Clients can educate and influence customers and potential customers with their most relevant marketing messages at the very time that they are most likely to act upon them,” says Jenny Day, Dowden Health Media senior VP and group publisher. Pharsight Releases New Version of Drug Modeler Pharsight has released Drug Model Explorer (DMX) version 1.6. The release supports improved visualizations of predicted drug performance against user-defined target measures of clinical safety and efficacy that collectively define a product profile. DMX is a Web-based and desktop software tool that allows drug-development teams to explore the modeled efficacy, safety, and other performance attributes of a new drug versus competing therapies. DMX results are presented as a series of plots and tables that can be quickly updated based on presimulated models of clinical effect. Results are accessible from networked desktop or laptop computers for individual exploration, interactive team discussion, and communication of development strategies and program alternatives with senior decision-makers. The tool displays the chance that a modeled drug effect will meet a specific target profile, through additions to the software interface that present a probable result to support clinical development decision-making. DMX 1.6 provides the ability to create, explore, compare, and manage product profiles, using existing DMX data and functionality in combination with new profiles features. DMX 1.6, which continues to support the full set of end-user features available in previous releases, also provides an updated user interface for the desktop viewing application to provide the same look and feel as the Web-based viewer. Fingertip Formulary Provides Web Access to Claims Data Fingertip Formulary has released Analytics Rx, a proprietary Web-based platform that provides access to monthly prescription formulary and claims data. Managed care, brand team, and sales executives in the pharmaceutical industry can follow performance by tier status at an aggregate and plan-specific level. A set of online reports enables prompt access to monthly prescription claims data that can be analyzed in relation to formulary tier status. Data may be segmented by geographic area and health plan type and analyzed as a percentage of plans or covered lives. The trend capability of Analytics Rx enables the identification of formulary status changes longitudinally and the impact on prescriptions. “By seamlessly integrating formulary access and prescription performance data, the tool helps drive insight and understanding into the effects of formulary position on prescription sales,” says Mike Green, VP of sales and business development, Fingertip Formulary. Cytel and Tourtellotte Solutions Offer Integrated Trial Simulators Cytel Inc.’s DoseSim adaptive trial simulator has been combined with Tourtellotte Solutions’ tcVisualize clinical-trial supply chain simulator. The result is a product that provides an accurate simulation of the clinical supply and randomization necessary for response-adaptive clinical trials. Response-adaptive trials can reduce development lead times and costs and boost clinical-trial success rates. But the difficulties of performing response-adaptive randomization and the drug supply uncertainties inherent in adaptive trial designs are daunting. The Cytel-Tourtellotte simulation package resolves both problems, opening the way to wider adoption of response-adaptive trials. “Our integrated solution minimizes the risk of both stock-outs and overages for an optimal response-adaptive supply system,” says Ranganath Nayak, CEO of Cytel. “This solution opens up the value of flexible, adaptive trials.” In a separate release, Cytel has released East 5 Clinical Trial Design System. Cytel’s East 5 delivers tools to guide trial sponsors through the myriad trial design options, including adaptive, group sequential, and fixed sample size clinical trials. Major advances in East 5 include: expanded visualization tools for better understanding of trial design concepts among trial planners, clinical operations, and regulators; report-ready tables for protocol review and study results submission; and better designs for trials using smaller sample sizes. Archi-Tech Offers Custom Reporting System for Sales Teams Archi-Tech Systems is offering a custom reporting capability for pharmaceutical sales and marketing data. There is a full range of custom reports available from interactive Excel files featuring pivot tables to comprehensive scorecards with text and graphics highlighting individual sales performance and exceptions for immediate action. The reports provide pharmaceutical sales teams with customized, intuitive access to the information they need while on the road, without requiring deep analysis, manipulation, or review. Information is fully synchronized with the home office to ensure quality control from end to end. Aptuit Introduces Web-Integrated IVRS Aptuit has introduced Aptuit IVRS, a fully Web-integrated interactive voice response system (IVRS). Aptuit IVRS is an advanced system that uses the latest release of Clarix’s fully Web-integrated IVRS solution for randomization and clinical supply management. This provides Aptuit’s clients with a centralized control center for managing their entire clinical study (or multiple studies) in real-time via the phone or the Web. Aptuit IVRS has seamless integration capability with Aptuit’s Clinicopia platform, a clinical trial supply management suite. “We are actively and rapidly delivering on our promise to supply our biotechnology and pharmaceutical clients with application systems that allow them greater control over their clinical trials, and reduce the inefficiencies of the complex and specialized process of clinical-trial supply,” says Michael A. Griffith, CEO and founder of Aptuit. Argonauta Launches Patient Recruitment System Argonauta Communications has developed a cost-effective solution for patient recruitment: Recruitment Ready, which let clients choose from a variety of services that have high-quality professional advertising tools as well as the training, media, outreach resources, and motivational support clinical sites need to effectively use the materials. A media and outreach portfolio ensures that sites are targeting the right outlets to reach the appropriate populations. Argonauta coordinators ensure that recruitment stays top of mind and correlate the media dollars spent by each site with the results generated by those dollars, thus providing a true return on investment. ChoicePoint Launches Digital Chain-of- Custody Product ChoicePoint has launched a digital chain-of-custody product designed to improve the drug-testing process. While the drug-testing industry has been traditionally paper-based, technology now allows for a more efficient digital-based chain-of-custody process. ChoicePoint has created a standard for the digital process, thereby improving efficiency and results. ChoicePoint’s digital chain-of-custody product uses digital pen-and-paper technology to capture data and signatures for secure electronic delivery. The technology also handles the prepopulation of data between customers and clinics to reduce data entry. The solution provides real-time visibility and status regarding the digital form being completed at the collection site. A highly accurate digital image of each form is automatically created. In the event the form is lost or destroyed, an electronic memory of the file is available. This new solution enables collection sites to send immediate updates to ChoicePoint, eliminating the scan/fax process and stocking of lab forms through the use of an electronic forms process, says Bill Whitford, Senior VP and General Manager, Screening and Authentication Services at ChoicePoint. SAFE-BioPharma Offers Digital Standard Implementation Toolkit In an effort to streamline common industry processes by making them fully electronic, a group of the world’s largest drug companies is sharing plans and documents associated with adoption and use of the SAFE (Signatures and Authentication for Everyone) digital identity and signature standard. The SAFE Implementation Toolkit is an initiative of SAFE-BioPharma Association. The toolkit is an online repository of templates, reports, and analytical documents that reflects the collective experience of companies involved in the development and use of the SAFE standard. Much of the toolkit’s content comprises internal documents contributed by some of the industry’s largest companies. Edge Dynamics and SPS Unveil Integrated EDI Solution SPS Commerce’s outsourced electronic data interchange (EDI) services have been integrated with Edge Dynamics Demand Management Suite. With this combined solution, EDI data from SPS Commerce is passed automatically to Edge Dynamics making it easier for life-sciences organizations to identify and respond to changes in the demand chain. Customers using this integrated solution benefit from faster time to results, lower deployment risk, and greater value from their EDI investments. “Given the ever-increasing volume of sales transactions, life-sciences companies are looking for faster and easier ways to understand what is happening in the channel as well as to be able to take action when and where it’s needed,” says Todd Venetianer, VP, services, at Edge Dynamics. ClinicaSpace Launches Online Community for Clinical Research Professionals ClinicaSpace has launched a comprehensive career network for clinical research professionals and employers. The online resource delivers daily clinical news, events, blogs, newsletters, and clinical pipeline information. ClinicaSpace’s career network and content are focused toward clinical-trial site managers, study monitors, data managers, project managers, regulatory affairs professionals, study coordinators, QA/QC auditors, and other clinical professionals in the biotechnology, pharmaceutical, and medical-device industries, and healthcare settings. In addition, ClinicaSpace maintains an extensive database of resumes where employers have access to a global community of clinical research professionals and job candidates. ClinicaSpace also features information from BioPharm Insight, a resource for clinical pipeline information, market research, and competitive intelligence on the biotechnology and pharmaceutical industries. Skila Releases KOL Management Solution Skila has released its next-generation global key opinion leader (KOL) management solution, iAdvocate 2.0, with workflow designs based on the best practices of leading global pharmaceutical organizations. “Effective management of relationships with worldwide, national, regional, and even local KOLs is critical to the success of global pharmaceutical companies and brands,” says Simon Mason, chief operating officer at Skila. “Few companies have developed a process and capability integrated well enough to focus on the entire KOL relationship management process in a measurable way, especially on a global scale. This poses a major challenge as global organizations strive to create a coordinated and consistent approach across countries, business units, and functional areas.” Verticals onDemand Launches CRM Application for Managed Care Verticals onDemand has released VBioPharma, a CRM solution for the increasingly important managed care area of U.S. pharmaceutical companies. The product is also Verticals onDemand’s inaugural product launch. “Managed care is a different animal, especially when it comes to CRM, and one that requires a unique understanding of the daily challenges a managed care account manager faces,” says Matt Wallach, VP of sales and marketing for Verticals onDemand. VBioPharma replaces outdated, home-grown systems and generic call-reporting software with a complete CRM solution that is fully integrated with primary and specialty care salesforces and marketing teams. The product includes detailed contact, account, and activity management modules, as well as business planning functionality. In addition, VBioPharma comes prepopulated with critical formulary data that can be kept up to date using Web services. Follow up Aptuit Inc., Greenwich, Conn., is a global company focused on streamlining and supporting the drug-development process for biotechnology and pharmaceutical innovators. For more information, visit aptuit.com. Archi-Tech Systems, West Trenton, N.J., is a provider of solutions for instant analytics and reporting for pharmaceutical sales, marketing, and managed-care departments. For more information, visit archi-tech.com. Argonauta Communications, Annapolis, Md., is a direct-response marketing company that provides support for clinical-trial recruitment, healthcare products, and healthcare services. For more information, visit argonautacommunications.com. ChoicePoint, Alpharetta, Ga., provides businesses, government agencies, and organizations with technology, software, information, and marketing services intended to help manage economic and physical risks as well as identify business opportunities. For more information, visit choicepoint.com. Clarix LLC, Wayne, Pa, provides an innovative suite of e-clinical software products. For more information, visit clarixinformatics.com. ClinicaSpace, Fort Worth, Texas, a division of BioSpace.com, an onTargetjobs company, is an online career network and community for the clinical research professional. For more information, visit clinicaspace.com. Cytel Inc., Cambridge, Mass., provides clinical-trial consulting services, specialized statistical software, and outsourced clinical study reports for the biopharmaceutical, medical device, academic, and research institute markets. For more information, visit cytel.com. Dowden Health Media, Montvale, N.J., is a full-service healthcare communications company that specializes in communication with both the providers and consumers of healthcare. For more information, visit dowdenhealth.com. Edge Dynamics Inc., Redwood City, Calif., is a provider of dynamic demand management solutions for the life-sciences industry. For more information, visit edgedynamics.com. Fingertip Formulary, Glen Rock, N.J., offers formulary data covering commercial, Medicaid, Medicare, and PBM plans in the United States, as well as data and marketing solutions for the pharmaceutical industry, consultants, and healthcare providers. For more information, visit fingertipformulary.com. First Light ERA, New York, provides white label contextual advertising and search technology for online publishers. For more information, visit firstlightera.com. IBM, Armonk, N.Y., is a global information technology company. For more information, visit ibm.com. MedConference LLC, Norristown, Pa., provides live, Web conferencing solutions to the life-sciences industry. For more information, visit medconference.net. Perceptive Informatics, Waltham, Mass., the technology subsidiary of Parexel International Corp., combines clinical knowledge, quality, and regulatory experience to decrease time to market, risk, and costs associated with clinical trials. For more information, visit perceptive.com. Pharsight Corp., Mountain View, Calif., provides software and strategic services for optimizing clinical drug development, and develops and markets integrated products and services for pharmaceutical and biotechnology companies. For more information, visit pharsight.com. SAFE-BioPharma Association, Fort Lee, N.J., is a nonprofit association that developed and manages a secure identity management and digital signature system designed to streamline processes and reduce costs in the pharmaceutical and healthcare industries. For more information, visit safe-biopharma.org. Skila, Morris Plains, N.J., delivers global brand effectiveness solutions and platforms to pharmaceutical and biotechnology companies worldwide. For more information, visit skila.com. SPS Commerce, Minneapolis, is a trading partner integration center offering fully outsourced electronic data interchange (EDI) and catalog capabilities. For more information, visit spscommerce.com. Tourtellotte Solutions, Wayland, Mass., is a global company that provides off-the-shelf and custom supply-chain software for the pharmaceutical, retail, and consumer goods markets. For more information, visit tourtellottesolutions.com. Verticals onDemand, Pleasanton, Calif., is a privately held company that leverages the salesforce platform to deliver on-demand CRM solutions for specific industry segments. For more information, visit verticalsondemand.com.