NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
86 S e p t e mb e r 2003 PharmaVOICE EMEDIA NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES optiTRAX, a budgeting and workflow manage ment tool launched by Blue Diesel, has been devel oped specifically for the pharmaceutical and biotech industries. optiTRAX is a secure Webbased applica tion that allows companies and their external mar keting partners to plan, manage, and control the creation, launch, and tracking of marketing com munication tactics across different brands and teams. “Within a single pharmaceuti cal company, there are usually 10 to 15 brand teams that are all con ducting similar marketing activi ties,”says JohnRacik,president and CEO of Blue Diesel.“But the cost of executing activities often varies widely from team to team. One may spend $10,000 for a fourcolor sales aid while another may spend $50,000 for a similar piece. Until recently, there has been no way to com pare and manage these costs at a corporate level to ensure that teams are paying a fair price. With opti Donahoe Purohit Miller Introduces WEBBASED DATATRACKER Donahoe Purohit Miller Inc. (DPM) has developed Pharma Info Organizer, a Web based data tracker that allows clients to better manage their medical events.The tool, which initially was developed for managing events such as seminars and symposia, allows clients to access — minutebyminute in real time — the information they need about the status of their events. With Pharma Info Organizer, clients can keep track of attendee status, attendee summaries, venue updates, honoraria information, budgets and expenses, and even have access to postevent summaries such as who attended and get feedback. Additional benefits of the “onestopshopping” of project status include reduction of fax and email reminders, less paperwork,and, in turn, time and cost savings. Pharma Info Organizer is available 24/7, and requires no special training to use. Pharma Info Organizer is used as a Webbased project manager by all divi sions of DPM. TRAX, we set out to create a tool that facilitates bet ter budget management, with the ultimate goal of helping companies save money on their marketing efforts without sacrificing creative quality.” optiTRAX allows companies and their advertising or marketing partners to create and maintain detailed estimates for all marketing initiatives online. As those initiatives are executed,actual resources and outofpocket costs are captured andcompared against the estimates. Product and brand managers have immediate access to realtime information about their expenditures. In addition, a central ized repository allows procurement and sourcing functions to analyze spending trends over time and across all product and brand teams. Acting as a single project repository, optiTRAX streamlines project management, reduces rampup time, and helps ensure consistent processes across brands, franchises, and reviewer functions. Blue Diesel Launches Webbased Application to Help Pharma Companies OPTIMIZE MARKETING BUDGETS “This new tool enables our clients to have uptothe minute information. Flexibility is built right into the program as Pharma Info Organizer can easily be customized to meet specific client needs,” says Michael Eicker, project manager, interactive, at Donahoe Purohit Miller. Liquent LifeSciences ELECTRONIC REGULATORY DOCUMENTMANAGEMENT SYSTEM Launched Liquent Inc.’s InSight Foundation is the first product in its new InSight family of solutions that integrates doc ument, publishing,and submission management technology.Designed to leverage emerging standards, such as the common technical document and electronic common technical document, InSight Foundation pro vides a validationready solution for optimizing the management of an organization’s submission documents. InSight Foundation extends a standard document management system (DMS) investment because it pro vides a configuration that uses industry best practices. As a result, organizations can avoid costly investments in a customized DMS,which has steered smaller companies away from document management technology. “InSight Foundation is the convergence of enterprisewide regulatory document control technology and automated regulatory submission assembly,” says Rick Dool,president and CEO of Liquent.“This new product demonstrates Liquent’s commitment to helping lifesciences organizations expand from straightforward sub mission publishing technology into regulatory document lifecycle management and publishing.” InSight integrates enterprise compliance processes, including creation,publishing,consumption,and man agement of content. optiTRAX is a secureWebbased application that acts as a single project repository. Octagon Unveils Process Management Software Tool Designed to SUPPORT SUBMISSION STRATEGY ANDDEVELOPMENT Octagon Research Solutions’ ViewPoint process management tool is designed to support the com plex electronic regulatory submission development process. This is the first of Octagon’s suite of Van tagePoint technology solutions and products. ViewPoint allows project managers to monitor and control every aspect of complex submissions through automated workflow manage ment, unobtrusive metric col lection, scenario modeling, issue tracking, and flexible task assignment. “Regulatory agencies are encouraging the pharmaceuti cal industry to provide elec tronic submissions and indus try is responding not just because of the initiatives but because of the business effi ciencies inherent in working digitally,” says James C. Walker, president and CEO of Octagon. “The tool reflects the process centric approach that our clients need to remain competitive by offering cost savings, significant risk reduction, and quicker timetomarket.” The program provides project managers with a standard to measure the speed at which compo nents of the submission are completed by includ ing a set of assumed metrics that incorporate best practices unique to the submission development process. James C. Walker, president and CEO, of Octagon says ViewPoint enables project managers and senior management to view the status and timing of electronic regulatory submissions in realtime. 87 PharmaVOICE S e p t e m be r 2 00 3 Emedia etrials Worldwide Inc. has launched QuickStudy Capture 5.0, electronic data capture (EDC) tech nology that simplifies and acceler ates the data collection process in clinical trials. The new version includes the capability to generate electronic case report forms (eCRFs) with either Borland’s Interbase or Ora cle8i as the database back end.This capability to use Oracle’s 8i database allows for tighter integra tion with newly acquired products in the etrials eclinical platform, such as PocketTrial, the electronic patient diary component. QuickStudy Build, the clinical trial design tool used to lay out the forms and to program the logic and fieldlevel validation, also has been updated to allow a study to be published to either Interbase or Oracle8i at the touch of a button. This tool allows nonprogrammers to build eCRFs on screen and link them to a database that is automatically formatted to collect and store vital study data. Through a technology transfer process, etrials can provide its clients with QuickStudy Build to facilitate internal study design. With the addition of an Oracle8i back end, spon sors using QuickStudy Capture can more easily access reports across different data types, such as diary, eCRF, or lab, because the prod ucts are integrated on a common platform. “QuickStudy Capture Version 5.0 with the Oracle8i back end lets sponsors keep all their unique data feeds in a common, industrystan dard format, which encourages the easy reporting of study trends and helps expedite the closeout of the study once data capture is com plete,” says Michael Harte, VP of global sales for etrials. Other features in the new ver sion of QuickStudy Capture include capabilities for midstudy changes and page level permissions, as well as an improved grid view.With site specific midstudy changes, the new protocol (e.g., adding a new exclusion question) can be intro duced in stages at those investiga tor sites that have received IRB approval, even when sites are still waiting for approval. Page level permissions give users custom views of a study, depending on the rights they have assigned to them. Some users may have readonly rights to view certain pages of a study without the ability to make any changes, while others may not have the necessary permissions to even view those pages. The new grid view features added filtering and group capabilities. etrials’ Electronic Data Capture Platform Provides TIGHTER PRODUCT LINE INTEGRATION MD Net Guide Launches PHYSICIAN PORTAL Intellisphere LLC has launched mdng.com. The new portal contains features to help doctors save time, increase health information accuracy,and prac tice efficiency. It was developed based on five years of data collected from monthly reader surveys. The site contains specialty microsites, which include eabstracts, medical sites, event listings, clini cal trials, patient friendly sites, and CME; link codes that can be entered from the print journal listing of the site the user wants to visit in the link code boxon the MDNG homepage; search features; and a limited log where users can subscribe, renew, change an address,or check on the status of a subscription to a journal or enewsletter. Wolters Kluwer Health Supports Brand,Portfolio, and Disease Management Marketing Managers with NEWWEBSITESERVICES Wolters Kluwer Health has launched a new por tal that provides branded,customized medical infor mation Websites for pharmaceutical and biotech nology companies.The company’s Corporate Portal Services offer the best of Wolters Kluwer Health’s content and technology services using the search interface from Ovid Technologies and peer reviewed content from Lippincott Williams &Wilkins (LWW), Adis International, MediSpan, and other WKHealth content and publishing sources. “By combining the technical power of Ovid and the content expertise of Adis and LWW,we’ve creat ed a powerful new tool for brand, portfolio, and dis easemanagement marketing managers,” says John Monahan, CEO of Wolters Kluwer Health’s Pharma Solutions division. “Our corporate portal services assist healthcare companies in providing medical professionals with easy access to research on a par ticular therapeutic area while effectively marketing the specific pharmaceutical brand and supporting drug prescribing practices.” WKHealth’s Pharma Solutions division works with customers to develop a customized Website focused on a select therapeutic category, such as oncology, infectious disease, cardiology, endocrinol ogy, or CNS.The site provides end users with access to an extensive collection of biomedical journals from Ovid, Adis, and LWW, as well as databases with links to fulltext articles andetables of content alerts. Additionally, other content is available on a payper view basis. Each site is developed by Wolters Kluwer Health and Ovid and is hosted on a secure Web server. In addition, Ovid technical support maintains and ser vices each site throughout the life of the contract. “Our clients want the technologies they use to all work together as seamlessly as possible,” says etrial’s Michael Harte. CRF Box Ltd.’s TrialMax clinicaltrial data capture toolkit seeks to provide the pharmaceutical industry with flexi bility and scalability by overcoming cur rent data capture inefficiencies. The tool can cut clinical study setup time by 50%,paper diary study budgets by 30%, and eclinical technology costs by 50%. Building on previous company technology,TrialMax incorporates novel features and workflow designed to inte grate ediaries into standard clinical R&D processes, globally and locally. “ TrialMax is designed to overcome the traditional eclinical challenges that are still hindering the pharmaceutical industry from scaling up ediaries as a standard part of clinical programs,” says Petri Rahja, chief technol ogy officer at CRF Box. TrialMax has five integrated components: Trial Studio, which allows users to design the trial; Trial Manager, a decisionmanagement and study management tool; TrialCol lector, a mobile, datacapture applica tion for a handheld environment;Trial Engine, which powers the clinical workflow between product compo nents; and TrialIntegrator, which pro vides oneway export capabilities for clinical data in SAS and CDISC XML formats. “ TrialMax has evolved from CRF Box’s technology and clinical knowl edge, collaboration with the compa ny’s large customer base, including 11 top global pharmaceutical compa nies, and experience gathered from our implementation in the industry’s largest electronic patient diaries,”says Timo Ahopel to, cofounder and worldwide VP of operations. Company executives say the product and its five modules are the result of listening to customers and those within the industry. CRF Box Tool Enables Companies to CREATE GLOBAL EDIARY STUDIES Petri Rahja, chief technology officer at CRF Box says TrialMax is designed to provide flexibility, business process integration, and scalability. 88 S e p t e mb e r 2003 PharmaVOICE Emedia Wingspan Technology has launched its Life Sci ences Toolkit, which allows companies to rapidly deploy portal technology into their ebusiness solu tions. A second product offering, DocWay, is a document manage ment Portal Toolkit that allows life sciences companies that use portal technology to more easily manage content created with enterprise contentmanagement solutions. Life Sciences Toolkit connects disparate systems allowing compa nies to more efficiently manage the integration and reuse of informa tion obtained during all phases of the pharmaceutical life cycle. The toolkit maximizes exposure and translation of existing resources and provides unified access to the data, which stream lines the critical decisionmaking process. Agile Launches LIFECYCLE MANAGEMENT PRODUCT for the MedicalDevice Industry AgileMD, recently launched by Agile Software Corp., enables organizations to bring quality prod ucts to market quickly,profitably, and in compliance. The product lifecycle management (PLM) solution was designed specifically for the medicaldevice industry. AgileMD helps medicaldevice companies increase revenue by accelerating time to market, increase profits by reducing operating and direct material costs, and ensure regulatory compliance. AgileMD is a complete PLM solution for manag ing the medicaldevice product record from research and development, clinical trials, regulatory approval ,new product introduction,market accep tance, to product phaseout. Quovadx LifeSciences Toolset DELIVERS AGILITY AND COMPETITIVE ADVANTAGE Quovadx Inc.’s recently launched Life Sciences Adaptive Framework is a set of reusable interopera ble components that complement the company’s business process management and integration plat form,QDX Platform V. The Life Sciences Adaptive Framework has been designed to enable pharmaceutical organizations to shorten development cycles, quickly respond to new business requirements, comply with govern ment mandates, and leverage and extend existing systems. The flexible approach to developing and supporting applications results in faster timeto market, as well as reduced training time, support costs, and likelihood of error. The Life Sciences Adaptive Framework consists 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 anddata based on an indi vidual’s role. Governmentmandated features support 21 CFR Part 11 and HIPAA compliance. Personalized and updated action and todo lists, based on automated standard operating procedures ensure processes are completed according to organizational guidelines while increasing employee productivity. Automated escalation provides functionality to keep projects on track and eliminate the numerous roadblocks that can impede completion through a succession of customizable alerts, reminders and action steps. These are available in a variety of out puts including email, Web forms, or automated server tasks. Other core components include auto matic task prioritization, performance tracking, expert assistance, worldwide connectivity, and pro file extensibility. Optas has made available Optas 5.0, which is designed to strengthen the directmarketing efforts of pharmaceutical companies and healthcare sys tems. Optas 5.0 provides marketing professionals with the infrastructure need ed to collect and maintain customer health information in a manner that is private, simple, and costeffective to implement. Optas 5.0 combines HIPAA compliant features with the ability to manage industryspecific data on physicians and consumers. “With more information available than ever before, patients are more proactive and have higher expectations regarding levels of service from all areas of the healthcare industry,” says Stephen Smith, CEO and president of Optas. “Optas 5.0 surpasses all reporting and campaign management solu tions by providing marketers at pharmaceutical and healthcare companies with a solution that addresses the unique regulatory and marketing chal lenges associated with healthcare.” Optas 5.0 offers marketers simplified campaign targeting and enhanced HIPAA compliancy tools. Optas 5.0 also offers significant updates to existing modules,as well as two new modules,Office Transformer and Survey Manager, which focus on the growing sophistication of database marketers in the pharmaceutical industry. It also offers advanced capability to target and manage surveys,audiences,and survey questions as well as report ing on survey results. Optas Release Designed to STRENGTHEN PHARMAANDHEALTHCAREDIRECT MARKETING EFFORTS Optas 5.0 is a solution that addresses the unique regulatory and marketing challenges associated with healthcare. DocWay works by allowing companies to embed any version of a content management com ponent into an enterprise portal or custom applica tion while retaining the application’s look and feel. “ Web po rt a l techno l ogy promises to bring significant effi ciencies to every aspect of the pharmaceutical life cycle by allow ing lifesciences companies to deploy and deliver content to both internal and external audi ences in real time and on a global basis,”says JohnMackey,director of life sciences for Wingspan. “We’ve developed these toolkits to pro vide lifesciences companies with industry specific solutions that enhance their ability to rapidly deploy technology and improve the flow of information, which ultimately reduces the time it takes to bring new drugs to market.” Life SciencesToolkit maximizes exposure and translation of existing resources andprovides unified access to data. Stephen Smith Wingspan Solutions ENHANCEAND EXTEND ENTERPRISE PORTAL PRODUCTS for LifeSciences Companies Insight Model Collaborator Enables FASTER DECISIONMAKING FORMANAGEMENTTEAM Insight Inc. has launched Insight Model Collaborator (IMC), a viewer for data and analyses generated within SAILS 21 supply chain design software. IMC enables the functionality of the SAILS interface, which allows man agers and other nonanalyst users to review data and analysis in the form of a map,chart, report, or data export. The IMC software is a casual user view into supplychain design and analysis from SAILS 21Version.The soft ware enables viewing of the solver output for complex, supplychain design models;empowers project team members to view and analyze the output of SAILS models;allows full view results/input data/edit/copy/save models/create capability; gives users a handson ability to view the model in its entirety; and includes SAILS data presentation tools, such as maps,charts, written reports, and data exports. 89 PharmaVOICE S e p t e m b e r 20 03 Emedia Automated Reservations for CONVENTIONDINING AND ENTERTAINMENT Impact Unlimited has launched an automated con vention registration system that allows companies to electronicallyschedule,reserve,and manage their dining and entertainment needs, as well as administer room registrations. Meeting Suite is designed to streamline tradeshow administration, by providing a centralized, online tool that attendees can log onto — and in real time — review, book,update,and revise tradeshow and offsite arrangements. Impact Unlimited prescreens and identifies restaurants, and profiles them online. Atten dees can log on and choose from scores of clubs,eater ies,and fine dining,book tables online and update reser vations right from the show floor. For pharmaceutical clients, Meeting Suite automatically flags noncompliant events and allows managers to make changes that meetall pharmaceutical guidelines.The systemoffers an online concierge service that identifies events and activ ities around the convention city and allows for online booking of events. The recently launchedWorkshare Synergy software is a document content collaboration application that is a professional solution for Microsoft Word multiauthored document collaboration. Workshare Synergy adds advanced functionality to Microsoft Word by automating the process of compiling and integrating proposed changes from multiple individuals into a single document. Workshare Synergy has been designed to enhance Microsoft Word’s ability to handle the complexities of multiauthored document collaboration. The product enables Microsoft Office professionals to easily understand what changes were made to their documents, who suggested them, and when they were proposed. Workshare Synergy can be used for document collaboration with both internal colleagues and external clients.Within an organization,Workshare Syn ergy can be used either as a managing author or as an internal contributing author role, with full access to the workinprogress. All parties can view changes made directly to the evolving document as they are being proposed, but only the managing author can apply the sug gested changes to the master document. Individuals external to the organization also can contribute to the workinprocess by using the freely dis tributable Workshare Synergy Editor. This editing utility lets external parties comment and suggest changes to a document.Those changes can then automatically be incorporated into the master document.This fea ture also provides for the master document to record a history of all proposed changes and versions of the work in progress. Workshare Application SOLVES COMMON PROBLEMS Associated With Document Content Collaboration Workshare Synergy adds advanced functionality to Microsoft Word. AGILE SOFTWARE CORP.,San Jose, Calif., helps companies drive profits, accelerate innovation, collaborate with partners,and leverage intellectual property throughout the product life cycle. For more information,visit agile.com. BLUE DIESEL,Columbus,Ohio, is an interactive communications company that blends strategic marketing, technology, and creative design to provide evidencebased interactive solutions for clients. For more information,visit bluediesel.com. CRF BOX LTD.,Waltham,Mass.,provides validated electronic patient diaries and mobile data capture on a global scale. For more information, visit crfbox.com. DONAHOEPUROHITMILLER INC., Chicago, is a healthcare advertising agency that provides professional and consumer patient services.For more information, visit dpmadvert.com. ETRIALSWORLDWIDE INC.,Research Triangle Park,N.C., is a provider of eclinical software for the collection,integration,and review of data in the clinicaltrial process. For more information,visit etrials.com. IMPACT UNLIMITED,Dayton,N.J.,is a creative and strategic company that provides a breadth of products and services that help clients optimize their investments in events,exhibits,and meetings.For more information, visit impactunlimited.com. INSIGHT INC., Manassas,Va.,provides software and consulting for optimizationbased planning and scheduling to solve the supply chain management issues of companies.For more information, visit insightmss.com. LIQUENT INC.,Fort Washington,Pa.,provides content assembly,publishing,and regulatory and intellectual property information solutions for the lifesciences industry.For more information, visit liquent.com. MDNETGUIDE,Plainsboro,N.J., is the flagship publication of Intellisphere LLC,which integrates both electronic and print media to provide physicians with userfriendly access to online medical content.For more information visit mdnetguide.com. OCTAGONRESEARCH SOLUTIONS INC., King of Prussia, Pa., is a processcentric solutions provider that offers a suite of regulatory electronic submissions, regulatory affairs, clinicaldata management, statistical, and information technology services to the lifesciences industry. For more information, visit octagonresearch.com. OPTAS,Woburn,Mass.,provides privacysafe Follow up database marketing software and services that allow pharmaceutical companies and health systems to communicate more effectively with customers. For more information, visit optas.com. QUOVADX INC., Englewood,Colo.,provides business infrastructure software and services, including consulting, transaction hosting,and operations management for businesscritical applications.For more information, visit quovadx.com. WINGSPANTECHNOLOGIES INC.,Blue Bell, Pa., is a management consulting and software technology company.For more information, visit wingspantech.com. WOLTERSKLUWER HEALTH,Yardley,Pa., part of Wolters Kluwer NV, Amsterdam,the Netherlands, is a leading global provider of information for medical and health professionals.The Pharma Solutions division provides business and clinical intelligence, communications support, and peer reviewed literature and database tools to the pharmaceutical industry.For more information, visit adisinsight.com. WORKSHARE,San Francisco, develops document contentcollaboration solutions to a wide variety of vertical markets. For more information, visit workshare.net.