NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES
Clinical Ink has introduced clinicalink.com, a Website that provides corporate information and detailed explanations of the Clinical Ink eSource solution for the electronic capture and storage of data during clinical trials. The company also has announced plans to release in June version 1.0 of its eSource solution. Clinical Ink’s eSource consists of tablet PCs running propri etary software that allows data entry on customized docu ments that retain the look and feel of paper datacollec tion forms, as well as a Web portal accessible from any Internetconnected computer. “Our system eliminates multiple data entry, increases accuracy and ulti mately saves money by reducing the time to market,”says CEO Doug Pierce. “It also allows customers to manage, view, and store the data and forms on our secure Web portal.” To create this technology, Clinical Ink entered into an exclusive world wide license with Datasci, owner of a patent regarding the collection and validation of clinical trial data over the Internet. In return,Mr.Pierce says,Datas ci has subsequently invested in Clinical Ink and is an integral part of its success. To date, Datasci has been granted six nonexclusive patent licenses in the electronic data capture marketplace. Clinical Ink Launches WEBSITE,PLANS PRODUCTRELEASE ClinPhone’s newest addition to its clinical technology portfolio integrates its electronic data capture (EDC) and randomization and trial supply management applications into one product, offering clients a comprehensive solution for managing clinical data. ClinPhone EDC combines the functionality of paper data entry with the flexibility of EDC into an electronic clinical data manage ment platform based on Microsoft connected technology and servers. Both ClinPhone Randomization and ClinPhone Trial Supply Management use interactive voice response (IVR) and interactive Web response (IWR) technologies to provide centralized manage ment of clinical trial randomization and supply chain logistics. ClinPhone Offers INTEGRATED TRIAL MANAGEMENT SOLUTION BridgeNet Releases SUPPLYCHAIN MANAGEMENTTOOL Xonar, a new W e b b a s e d global visibility tool from Brid geNet Solutions, allows health care and lifesci ences profes sionals to manage their global supply chains from any where in the world. The net workspend data analytics and planning solution uses advanced optimization technology to manage complex supply chains and includes an executive dashboard,360degree logistics performancemoni toring capabilities, exception/event management capabilities, and realtime reporting, analysis, and a global communications tool. Xonar enables supplychain professionals to per form a quick analysis and assessment of their global transportation costs and service requirements, as well as the calculation of the optimal network con figuration for different cost and service objectives. Solutions from the model can be viewed,compared, and easily exported to tables and graphs for presen tations and further analysis. The system provides Phase IV cost visibility and compliance. All modes of transportation imported into a central repository database, providing a dash board with advanced features: exceptions/event management, compliance, internal alignment with all business entities, trends analysis, forecasting and demand planning, and business process manage ment for proactive cost initiatives. Xonar enables supplychain professionals to perform a quick analysis and assessment of their global transportation costs and service requirements. ClinPhone’s newest addition to its clinical technology portfolio integrates its electronic data capture (EDC) and randomization and trial supply management applications into one product. Our system eliminates multiple data entry, increases accuracy and ultimately saves money by reducing the time to market, says Clinical Ink CEO Doug Pierce. Intrasphere Technologies has launched PharmaCM, a comprehensive content man agement solution designed to help clients more effectively manage drug information critical to patient safety, including the content for drug labels, clinicaltrial protocols, and drugsafety reporting. PharmaCM,which is powered by Microsoft Office SharePoint Server 2007 (MOSS), is a seamless, userfriendly system that enables organizations to overcome inefficient con tent authoring, management, and distribution processes in a costeffective manner.The solution provides an intuitive and familiar interface for generating a series of regulated documents, including protocol disclosure forms required for registration on clinicaltrials.gov,as well as the structured product labels (SPL) required by the U.S.Nation al Library of Medicine’s DailyMed Website. PharmaCM also includes a submissions management and authoring module to help clients create content and easily prepare for NDA submissions following electronic com mon technical document (eCTD) standards.Users can nowmanage the complex process of planning, authoring, reviewing, approving, and releasing submission content from a common portal. “It is critical for lifesciences organizations to have the ability to create and manage content such as product labels, clinical protocols, and study reports while at the same time staying in compliance with the latest regulations, including the recent FDA Admin istration Act,”says Woo Song,cofounder and chairman of Intrasphere.“PharmaCM makes it possible for them to easily manage this process in a familiar Microsoft environment.” Intrasphere Launches CONTENTMANAGEMENTTOOL It is critical for life sciences organizations to have the ability to create and manage content while at the same time staying in compliance with the latest regulations, says Woo Song, Cofounder and Chairman of Intrasphere. 0408 Layout FINAL MW 3/21/08 11:45 AM Page 96 97 PharmaVOICE Ap r i l 2 008 Emedia # Advanced Clinical Software (ACS), Seattle, has expanded upon its flagship StudyManager clinical trial management software (CTMS).StudyManager Sponsor Edition (SE) provides clinical data collection, study management,and realtime interaction among study administrators, monitors,and site users. For more information, visit studymanager.com. # Almac Clinical Technologies,Yardley, Pa., has expanded its Express Suite to incorporate the company’s iTrial EDC electronic data capture and IXR Express interactive voice andWeb response capabilities. Employing Almac’s fully integrated,costeffective IXR/iTrial EDC Express Suite, sponsors benefit by reducing study startup times,eliminating data entry redundancies,and streamlining overall study timelines. For more information, visit almacgroup.com. # BioWizard,Wayne,Pa.,has added a set of personalization utilities to its online information and communications platform for the biomedical research community.Known as myBioWizard,or myBW, these personalization tools enable BioWizard users to develop a customized homepage.BioWizard has also added PubMed search enhancements to its lifesciences platform.Furthermore,myBW offers syndicated news feeds from more than 70 lifesciences universities. For more information, visit biowizard.com. # Contract research organizationBeardsworthConsultingGroup,Flemington, N.J., has released BNet3, the newest version of its clinical trial management system (CTMS) for providing clinical trial data to its pharmaceutical clients.BNet3 improves upon previous versions by integrating realtime data into the clinical trial process. Its modular approach allows realtime tracking and updating of metrics from the field and provides users with quick,accurate data in the required format. For more information, visit beardsworth.com. # Datatrak International, a Clevelandbased technology and services company focused on global electronic solutions, has announced the release of Datatrak eClinical. Enhancements include VisualArchitect, a draganddrop interface for designing clinical trials; eTrain, an online training tool for datacollection and investigator review, as well as a new trialmanagement workflow tool that allows virtual teams to set up and deploy clinical trials through a Web browser. For more information, visit datatrak.net. # Liquent, a Thomson Scientific company,has announced the availability of InSight Publisher 3.6. InSight Publisher enables pharmaceutical companies to create, manage,and publish regulatory submissions in both paper and electronic format using a single software application. This newest version adds intuitive hyperlinking and crossreference management to InSight Publisher’s enhanced functionality set. For more information, visit liquent.com. # Medidata Solutions, NewYork, has released Medidata Rave 5.6.2, the newest version of its electronic data capture (EDC) solution for clinical trials.With this version, Medidata has incorporated its elearning module directly into the Rave system.Upgrades include a publishin EUPGRADES AND ENHANCEMENTS place function that allows immediate updating of CRF versions during development and a custom function development utility that assists in development and testing of custom edit checks. For more information, visit mdsol.com. # Octagon Research Solutions,Wayne,Pa., has added a number of new features to its StartingPoint suite of submission documents authoring templates.Tools incorporated into StartingPoint 3.0 include a document validation button,document information for field codes, keyboard shortcuts, improved table functionality, and additional content templates for the United States and Europe. For more information, visit octagonresearch.com. # PedagogueSolutions,Princeton,N.J.,has released version 9.0 of its PedagogueAssessmentManagementSystem.Pedagogue AMS9offers enhancements to the online assessment system’s delivery,authoring, reporting,and administration platforms.New features include testing by learning objective,more flexible scoring and testdelivery options, email notification,and individualized remediation plans. For more information, visit pedagogue.com. # Phase Forward,Waltham,Mass.,has announced Central Coding for InForm 2.0, a new release of a Webbased application for updating clinical study data to reflect the terms for adverse events and medical coding from the latest industrystandard dictionaries.The latest version is optimized to code clinical data using these dictionary terms within Phase Forward’s InForm Integrated Trial Management (ITM) electronic data capture (EDC) product. For more information, visit phaseforward.com. # Phoenix Data Systems (PDS), King of Prussia, Pa., has added randomization and clinical supply management capabilities within its PDS Express electronic data capture (EDC) application. EDC Randomization encourages sites to immediately enter qualified patients into the EDC system and randomize them as they are enrolled, improving the sponsor’s visibility regarding enrollment.PDS Express’clinical supply management capability allows sites to use either the EDC system or PDS IVR to record the use of clinical trial supplies. For more information, visit phoenixdatasystems.net. # Systech International,Cranbury,N.J., has introduced version 8.0 of its SystechTIPS Engine packaging execution system. Its new interface employs icons to visually represent components and functions of the packaging execution system,allowing packaging line engineers to easily assemble and realign these icons as they implement and modify their packaging lines. For more information, visit systechtips.com. # Verticals onDemand,Pleasanton,Calif., now offers a primary care version of its VBioPharma CRM application.VBioPharma Primary Care Edition CRM is a CRM solution prevalidated for PDMA and FDA compliance. The solution provides outofthebox call reporting and sampling system with complete IQ and OQ documentation. For more information, visit verticalsondemand.com. 0408 Layout FINAL MW 3/21/08 11:45 AM Page 97 98 Ap r i l 2008 PharmaVOICE Emedia Publicis Selling Solutions Introduces WEBBASED CONTACT MANAGEMENTTOOL Publicis Selling Solutions, a Publicis Selling Solutions Group company, has developed SFA Sidekick, a Webbased target management tool that allows field sales representatives and homeoffice staff to make pre scriberprofile and callplan changes more easily and effi ciently. SFA Sidekick offers sales reps, sales managers,and homeoffice operations person nel a collaborative tool in which each stakeholder has input into their territory changes.The solution is customized to incorporate each client’s specific busi ness rules so that reps are immediately aware of the impact of any recommended changes, and its Web based interface allows users to access the planned changes along with an intuitive approval workflow from any Internetenabled computer or device. SFA Sidekick can also be integrated with all SFA systems, regardless of the platform being used. “SFA Sidekick can turn these routine, largescale salesforce automation (SFA) edits from a painful pro cess into one that is infinitely easier and more effi cient,” says Rick Keefer, chief operating officer. He says SFA Sidekick mirrors the information in the sales representatives’ SFA system. This allows changes to take place in a `safe’ environment that is flexible enough to incorporate collaboration from the sales managers and the home office. MDSUnveils WebBased STUDYMANAGEMENT SYSTEM MDS Pharma Services has launched Apollo, a unified, Webbased studyman agement tool that provides clients with secure, transparent tracking of study sam ples and results and realtime, worldwide virtual access to their study data. The new solution provides customers with significant benefits in terms of efficiency and standardization in study management.The system provides for global stan dardization of requisitions, reports, kits, barcode labels, as well as scientific infor mation. The Apollo system, developed for MDS Pharma’s Global Central Lab business, strengthens the chain of custody from specimen collection, to central lab receipt, to testing and sample storage. Apollo provides a single interface for all aspects of protocol management, including protocol specifications, kit building, sample reception and test ordering, query identification and resolution, customizable results flagging, report distribu tion, frozen sample management,data extraction and invoicing. Apollo improves the efficiency and quality of MDS Pharmamanaged studies and enables the com pany to respond quickly to changes in client needs and study requirements, regardless of where the client is or where the work is being done. “A single global system with increased transparency of processes and data across all our sites will help us consistently deliver on our brand promise of quali ty, ontime results,” says President David Spaight. “The Apollo system, which is exclusive to MDS Pharma Services, will help to redefine the customer experience, allowing studies to start on time, run smoothly, and end on time.” The new system is built on an Oracle database and provides client study teams a host of features that enable greater control over all aspects of the study. These features include: . A dashboard for highlevel overview of a trial, including automated kitexpiration and testcancellation noti fication, alert/exclusion reports, and query notices regarding preprogrammed escalations. . Automatic detection of late or missing batch samples, thirdparty shipping list templates, automatic recall site notification, recall of frozen samples from affiliate laboratories, and global frozen sample inventory reports. . Kitbuilding support, including latest bills of material, kit component inventories with specific lot numbers and expiration dates, and prelabeled tubes for delivery to study sites. Manhattan Research Introduces CONSUMERRESEARCH SERVICE Manhattan Research has introduced ePharma Consumer, a service that provides subscribers with insight into the way U.S. consumers are using pharmaceutical information online based on an online study gen erating more than five years of trended data.Topics explored by ePhar ma Consumer include online pharmaceutical information resources; DTC advertising; utilization and trust of online prescription information; pharmaceutical company and product Websites; and use of search engines, blogs, Podcasts,Wikis, and social networking. “ePharma Consumer provides our agency and pharmaceutical clients with insight into how consumers are using branded and unbranded pharma properties online today,”says Meredith Abreu Ressi, VP of research for Manhattan Research. “Combining this research with server and usage data is critical to painting a complete strategic picture of the online consumer marketing and media landscape.” Pharma companies and agencies use ePharma Consumer for budget planning,productsite development, market sizing,and ROI measurement for online initiatives.The research and advisory service helps planners and marketers: . Examine consumer use of pharmaceutical information online and trends over time. . Determine the impact of Web 2.0 on consumer pharmaceutical marketing strategy. . Identify utilization trends for more than 30 corporate and more than 150 branded product sites. . Determine the profile of online visitors by brand (Rx status, caregiver, or informationseeker). . Assess the actions taken offline after visiting product sites compared with competitor sites. . Features and tools desired by consumers visiting product sites. ePharma Consumer provides our agency and pharmaceutical clients with insight into how consumers are using branded and unbranded pharma properties online today. SFA Sidekick offers sales reps,sales managers,and homeoffice operations personnel a collaborative tool. A single, global system with increased trans parency of processes and data across all our sites will help us consistently deliver on our brand promise of quality, ontime results, says MDS Pharma President David Spaight. Roska Healthcare Introduces CORPORATEWEBSITE Roska Healthcare Advertising’s new Website, roskahealthcare.com, offers visi tors a virtual tour of the agency’s people, clients, and category experience. Intuitive navigation allows viewers to explore information by disease category, product life cycle, or audience,providing a person alized, productive experience tailored to their specific needs. “The site makes robust use of imagery, video segments, and logicbased naviga tion that enable visitors to engage with Roska Healthcare to gain a true sense of what it is like to work with the agency,” says Chris Matsinger,VP, digital services.“A good example is a streaming video of the firm’s president, Jay Bolling, offering some insightful perspective on DTC advertising and the value of touchpoints, varied media,and engaging the consumer.” The site makes robust use of imagery, video segments and logicbased navigation that enable visitors to engage with Roska Healthcare, says Chris Matsinger, VP, Digital Services of Roska Healthcare. 0408 Layout FINAL MW 3/21/08 11:45 AM Page 98 Emedia ISI, EMC Create REGULATORY SUBMISSION SOLUTION for Midsize Companies Image Solutions (ISI) has extended its relationship with EMC, enabling the company to cosell ISI’s integrated regu latory suite with EMC’s Enterprise Con tent Management solutions. The ComplianceinaBox (CiB) Sub mission Edition is a prepackaged, inte grated regulatory compliance solution that gives organizations the flexibility to submit using paper or the electronic common technical document (eCTD) format.The combination of a document management solution packaged with a publishing system allows midsized companies to achieve enhanced con tent creation and management, eCTD generation, and true document life cycle management in a simple, cost effective manner.The backbone of the CiB solution is EMC’s Documentum Compliance Manager (DCM) combined with Impact Systems’accelerator configu ration package. “The decision to target the midmarket is fueled by our belief that these companies have the same sophisticated needs as their marketleading coun terparts,”says Paul Chung,executive VP of ISI. DrugLogic has unveiled QscanRM, an extension of its Qscan ERM workflowmanagement product line that provides rapid implementation of a riskmanagement solution to small and mid sized organizations, giving them the benefits of workflow and data interface functions without the hassle of a custom implementation. The QscanRM solution expedites and eases the implementa tion of a major system. In addition, migration to full QscanERM in house operations will be facilitated. “Companies with fewer work steps and departments still require total regulatory compliance,” says Victor Gogolak,president and CEO.“What we offer is an easily tailored process — a starter set workflow,standard alert definitions — and the ability to map proprietary data based on years of experience in risk and event manage ment.Over time, the workflow model can be adapted to growth and drug numbers.” QscanRM consists of three core