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New Electronic and Web-based Applications, Sites, and Technologies

DataLabs Launches Products to Enhance e-CDM

DataLabs has released DataLabs Clinical, a single data-management system that unifies the functionality of paper data entry (PDE) with the flexibility of electronic data capture (EDC). DataLabs Clinical is an electronic clinical data management (e-CDM) platform that enables the biopharmaceutical and contract-research industries to streamline clinical data management processes and reduce the time and costs associated with clinical trials. The solution includes modules for study design, data capture, and data management in a single, integrated application designed to accelerate clinical trials. It is entirely browser based, allowing customers the functionality of a thick-client application (PDE) with the flexibility of a Web-based system (EDC). As an electronic clinical data management platform, DataLabs Clinical includes clinical-trial status reporting functionality, event notifications pushed to external platforms, such as e-mail and mobile phones, and the availability of connectors to “best of breed” external applications. Based on Microsoft technology, DataLabs Clinical is available in four segment-specific editions suited to the needs of companies across the life-sciences industry, including contract research organizations (CROs), small and midsized biopharmaceutical companies, large biopharmaceutical companies, and academic/clinical institutions. In other news, DataLabs and Galt Associates Inc. have partnered to integrate Galt’s dsNavigator coding and dictionary-management product with DataLabs e-CDM platform. The result is a single, integrated solution that combines the robust features of these two best-of-breed software applications. Galt’s dsNavigator is a Web-based solution that offers rapid and accurate coding of adverse event and drug verbatims throughout each phase of clinical research. Featuring a configurable and easy-to-use interface, dsNavigator provides a single solution for dictionary management, searching, browsing, and batch or interactive coding. DataLabs Clinical allows biopharmaceutical companies, CROs, and academic institutions to conduct true hybrid studies without the difficult and time-consuming data integration from two databases, says Jim Langford, President of DataLabs Inc. Dendrite Solution Addresses State Reporting Requirements Dendrite International Inc. has released a solution to help pharmaceutical companies navigate the growing number of U.S. state regulations governing marketing and advertising, sales promotion and expenses, and pricing disclosure. The new solution features State Guardian, a reporting engine that identifies and imports disparate data, rationalizes that data for a single view of the customer, and provides state-level reports for evolving state legislative requirements. The new solution also includes State Monitor, a centralized, on-demand, Web-based tool that delivers 24-hour access to up-to-date analyst insight into U.S. legislation and requirements. Both tools are powered by Dendrite’s BuzzeoPDMA division, which offers U.S. state and federal compliance and regulatory solutions. Dendrite developed this solution in response to the increasing number of state legislative report and disclosure requirements. Four states, Vermont, Minnesota, Maine, and West Virginia, plus Washington D.C., now require pharmaceutical companies to report marketing and advertising, sales promotion and expenses, and/or pricing. California has passed self-regulatory disclosure requirements; 13 additional states have disclosure legislation pending. Each state’s reporting requirements are unique and evolving, which makes the ability to standardize and remain current a significant challenge; failure to comply can result in severe fines. State-based regulations have set in motion a domino effect that will continue to gain force over the next few years, says Ronald Buzzeo, R.Ph., Chief Regulatory Officer at Dendrite International Inc. Lathian Releases Web-based Medical Promotion Solution Lathian Systems Inc. has unveiled its new Web-based Medical Promotion solution, offering pharmaceutical marketers a suite of interactive tools for rapidly developing online marketing campaigns. This suite enables sales and marketing teams to pick and choose the most relevant strategies from the following five proven online promotional programs: • E-details that provide custom multimedia and interactive video. These online multimedia promotional presentations integrate brand information, which can be finely customized to increase reach and brand awareness and perfect messaging. • Fast e-details that fill in the blanks, which offer supplemental product and brand messaging, without creating an entirely new campaign. Limited to three to five screens and focused exclusively on one area, Lathian’s fast e-details quickly amplify traditional e-details in a condensed, easy-to-read format. • E-lerts that quickly deliver news and updates. Lathian’s e-lerts “broadcast” time-sensitive information — such as clinical-trial results, new formulations, and new packaging — to targeted audiences via e-mail. • Conference e-details, which allow pharma marketers to use e-detailing technology on show floors at dedicated kiosks activated with a swipe card. This provides physicians with medical updates and product information at an educational event. • Integrated e-sampling that opens a virtual sample cabinet. Lathian’s research shows that 40% of physicians request a product sample after finishing an e-detail. With e-sampling, physicians simply click on a link at the end of an e-detail to get instant access to sample drugs and related drug information. “Our research shows that interactive, Web-based technology gives life-sciences marketing and sales teams 20 times more minutes on message for the brand than traditional office visits, a huge feat considering the elusive nature of today’s physicians,” says Robert Bedford, senior VP of sales and marketing at Lathian. Lathian’s Medical Promotion suite enables sales and marketing teams to pick and choose the most relevant strategies from a line up of five proven online promotional programs. State-based regulations have set in motion a domino effect that will continue to gain force over the next few years, says Ronald Buzzeo, R.Ph., Chief Regulatory Officer at Dendrite International Inc. Elsevier IMNG Launches Podcast of Clinical Neurology News Elsevier’s International Medical News Group (IMNG) has launched STAT!. Elsevier’s International Medical News Group (IMNG) has launched STAT!, a weekly medical news podcast that offers articles from the publisher’s medical-specialty newspapers in an entertaining and accessible audio format. Each STAT! podcast contains more than 20 minutes of compelling clinical information tailored for specialty physicians. “Podcasts are an important new platform for medical news, enabling busy practitioners to access the information that they need from a mobile device, such as an mp3 player, or from their desktop or laptop computers,” says Alan Imhoff, president of IMNG. “We recognize physicians want choice and control over how they access information.” Neurology was the first specialty podcast series, launched in January 2006. STAT! podcasts are hosted on medicalnewspodcast.com and available to physicians via IMNG publication Websites. Advertising spots are available on STAT!, with sponsorship available by physician specialty. Perceptive Informatics Updates Clinical-Trial System Perceptive Informatics Inc. has released its interactive Web response system (IWRS) version 2.0. The updated system integrates with the company’s interactive voice response system (IVRS) and offers a Web interface for data capture, patient randomization, and the management of study drug inventory for clinical trials. Version 2.0, featuring a richer user environment and improved performance, is a single Web application for reporting and interactive Web response. It allows study teams to access real-time Web reporting for all aspects of clinical-trial tracking, thereby enhancing the ability of clinical teams to make real-time decisions about key components of their clinical trials. The system’s interactive features include snapshots of project status as well as detailed study metrics, enabling trial monitors to follow progress of their sites, plan and prepare monitoring, and identify potential site issues such as slow enrollment and high dropout rates. Sponsors can also aggregate data from multiple sources — such as clinical trial management systems (CTMS), data management systems, and enterprise resource planning systems — to get a more comprehensive view of their clinical trials. The Perceptive IWRS solution allows for seamless convergence between voice and Web systems and provides tools for site recruitment and management, inventory management, and clinical supplies forecasting. The system can be configured for patient screening, enrollment, randomization, compliance, and electronic patient-reported outcomes (ePRO). The Perceptive IWRS is a fully validated system, compliant with 21CFR Part 11 regulations and guidelines. Sponsors could experience significant cost reduction and greater efficiencies in study management when IWRS is used to the fullest extent, says Todd A. Joron, Corporate VP and General Manager of Perceptive Informatics. C3i Introduces Online Laptop Repair Service for Salesforces C3i Inc. has launched an online solution to prevent, detect, and repair computer problems. The company’s new service diagnoses and fixes software issues and significantly reduces unnecessary laptop shipments, decreasing both salesforce downtime and information-technology support costs. One of C3i’s clients, a global leader in diabetes healthcare, recently completed a remote diagnosis and repair pilot. The solution enabled this company’s IT organization to reduce laptop shipments and repair costs by more than 30%. Also, because of VPN and firewall restrictions, some software-repair solutions do not allow access to remote users “We offer clients a cost-effective solution allowing them to repair their mobile professionals’ software issues behind the scenes, without any interruptions to open applications,” says Bob Piwko, chief operating officer of C3i. Since the majority of all hardware repair shipments are actually caused by software-related problems, we recognized that there was an opportunity to dramatically decrease the number of times a sales rep ships his or her computer for service, says Bob Piwko, Chief Operating Officer of C3i Inc. easyRegDocs Launches Regulatory Submission Service easyRegDocs has launched easy-Start, an outsourcing solution that handles the completion and submission of required regulatory documents for clinical trials. The service is designed to dramatically decrease the time it takes a researcher to begin participating in a trial, bringing savings and greater efficiency to both clinical-research sites and pharmaceutical sponsors. While designed for researchers, easyStart also benefits trial sponsors because the service enables expedited submission of all site regulatory documentation. This allows for faster start-up times, extends time for patient recruitment, and reduces costly study delays or timeline extensions. “The site can offload tedious, time-consuming work; and the sponsor saves significant money and time, preventing expensive delays in their overall study timeline,” says Ian Brill, easyRegDocs cofounder. Our easyStart service adds efficiency to the entire start-up process, says Ian Brill, easyRegDocs Cofounder. WKHealth Launches Tool to Assess Clinical Trials Wolters Kluwer Health has introduced an enhanced version of its Adis Clinical Trials Insight database, which assists pharmaceutical and biotech companies in the identification and assessment of the universe of clinical-trial studies for new drugs. Wolters Kluwer Health Pharma Solutions has re-engineered Adis Clinical Trials Insight to include the difficult-to-monitor ongoing studies and all trials presented at the top 100 meetings and published in the top medical journals. Adis Clinical Trials Insight allows users to review and evaluate product trial outcomes to identify strengths, weaknesses, and potential positioning of competitive products. It includes coverage of more than 40,000 published and ongoing trials per year. Also, improved indexing and biomarker endpoints allow users to evaluate study design and identify studies in which a specific endpoint has been used. We expect Adis Clinical Trials Insight to become the de facto standard for all clinical-trial decision making, says John Monahan, President and CEO of Wolters Kluwer Health Pharma Solutions. Model N Enhances Revenue Management Suite Model N has released its next-generation Revenue Management Suite, featuring industry innovations in usability and functionality. The new suite was designed to increase the productivity and ease of use for the company’s Web applications. The tool has faster response times, improved desktop look-and-feel for Web-based programs, and an easier way to manipulate data on a Web page. Additionally, Model N made more than 100 customer-driven enhancements to the suite, including the addition of contract auditing for Sarbanes-Oxley compliance. The Revenue Management Suite also features advanced business intelligence functionality with ad-hoc reporting and user-controlled charts and graphs. One of the product’s most significant enhancements is comprehensive price monitoring, including pricing floors, Best Price, FSS (Federal Supply Schedule), and net price monitoring. This functionality is a first in the industry for revenue management. Using Model N’s Revenue Management Suite, life-sciences organizations will realize greater success in controlling revenue leakage and managing regulatory compliance risk. Also, advances in Web usability will dramatically increase productivity and make application implementation much easier. Life-sciences companies need to leverage technology to align their pricing, contracting, and reimbursement processes into an end-to-end system and minimize revenue and compliance risk, says Stephen Zocchi, Model N’s VP of Marketing. StayinFront Releases New Version of CRM Mobile StayinFront Inc. has released StayinFront CRM Mobile version 9.3, which can be used as a stand-alone customer relationship management (CRM) application or to augment an enterprise implementation of StayinFront CRM. This latest release includes features tailored to the needs of remote sales and field workers, including those who rely on PDAs. With StayinFront CRM Mobile 9.3, organizations can deploy a broad range of features and functionality in a handheld application. This includes: sales and field force automation, customer management, order entry, and sample tracking. The application also features an enhanced user interface that is task driven and pen optimized. StayinFront CRM Mobile supports each client’s specific requirements. Additionally, the solution provides industry applications that are easy to configure, including electronic signature capture for sample management and order processing. It also has been designed to support multiple synchronization technologies. We have enhanced the user interface and improved the configurability to ensure mobile users always have easy-to-access business-critical information at their fingertips, says Tony Bullen, Chief Technology Officer of StayinFront Inc. Pharmaceutical Institute Launches e-Courses The Pharmaceutical Institute (PI) has launched a library of more than 40 e-courses, covering various therapeutic areas and disease states. The courses are available through PI’s online education center, which offers live and Internet-based applied educational resources and customized educational programs. PI’s e-courses cover a wide range of diseases and therapeutic areas, including cardiovascular, gastrointestinal, infectious disease, metabolic, musculoskeletal, neurology, oncology, respiratory, and rheumatology. Separate courses are also available within each therapeutic area. Each course provides comprehensive information on the anatomy and physiology involved using detailed images, common disease states, and mechanisms of action within each therapeutic area. Most courses are between two and five hours in length and are presented in a streaming multimedia format. PI will also work with companies to develop courses with specialized content. Our educational courses can help pharma and biotech industry professionals serving in commercial functions, such as sales and marketing, better understand the therapeutic areas in which they work, says Dan Blue, Executive Director of the Pharmaceutical Institute. Data-Management Services for Clinical Trials Launched by PDS Phoenix Data Systems (PDS) has expanded its e-clinical data-management services for Phase I to Phase IV clinical trials. PDS provides a complete data-management plan, along with a fully tested and validated system. PDS’ service includes additional activities that are traditionally outsourced in paper-based trials. These include: project management; e-CRF preparation and completion; manual review and query generation; query resolution; dictionaries, coding, and exception report approvals; coding guidelines; data correction plan; and final QC of study data. “Pairing these services with PDS technology is a powerful combination that helps sponsors to progress through the clinical-development process,” says William Claypool, M.D., CEO of PDS. PDS Data Management services provide sponsors with trained and experienced personnel. FFF Enterprises Launches E-Pedigree Web-based System FFF Enterprises Inc. has launched a new drug safety net that leverages the power of the Internet to track supply-channel security for pharmaceuticals distributed by FFF to hospitals, clinics, and physicians in Florida and nationwide. Originally launched in June 2004, the redesigned Verified Electronic Pedigree (VEP) allows healthcare providers to view and authenticate electronic drug pedigrees that are compliant with new regulatory requirements. VEP employs a sophisticated pharmaceutical pedigree security system developed by FFF’s partner SupplyScape Corp. The system is hosted by SupplyScape, which designed the VEP architecture to meet or exceed state and federal pedigree requirements. Using VEP, FFF’s customers can comply months ahead of schedule with Florida’s drug pedigree law, which will be effective July 2006 and will establish the most stringent e-pedigree requirements in the United States. Currently, 10 states have adopted drug-pedigree regulations similar to those in Florida, and more than a dozen states are following suit. Limiting the number of transactions protects products — and patients — from the risks of secondary and gray market distributors, which is typically where counterfeiters enter the supply channel, says Patrick M. Schmidt, CEO and President of FFF Enterprises Inc. Siperian Offers Data-Integration Hub Siperian Inc. has launched Siperian Hub XT, a multiproduct, data-integration platform that enables organizations to create and deliver accurate, unified views of customers and related locations, products, and assets across data silos in a real-time operational environment. Siperian Hub XT allows users to deliver these unified views to different business users from data stored across disparate sources and thereby drive business actions in a timely fashion for both operational and analytical purposes. With Siperian Hub XT, companies can create more efficient and profitable customer relationships, increase the accuracy of regulatory compliance efforts, and achieve better insights into the complete customer relationship, all while reducing traditional operational costs. Siperian Hub XT includes a critical third component, Siperian Activity Manager. The new Activity Manager enables users to create unified views by leveraging reference and relationship data — stored in Siperian Master Reference Manager and Siperian Hierarchy Manager — and aggregating transactional data stored outside of the hub. The integrated combination of Siperian Master Reference Manager, Hierarchy Manager, and the new Activity Manager provides organizations an IT platform for delivering complete, unified views of transactions across disparate applications, says Darlene Mann, CEO of Siperian Inc. Decision Resources Introduces Electronic Format for Pharmacor Text Decision Resources Inc. has released a new electronic format for Pharmacor, its report series that uncovers the commercial outlook for marketed drugs and drugs in development. The electronic interface offers users easier navigation throughout reports, a robust search capability, and easy printing options. “After many conversations with our clients, it was clear that we could take Pharmacor to the next level by upgrading the ease-of-use and navigation within each report,” says Sarah Fuller, president of Decision Resources. Pharmacor reports offer in-depth information on specific indications, including: epidemiology, etiology, and pathophysiology; current therapies, medical practice, unmet clinical needs, emerging therapies, and market outlook sections; and an interactive forecast tool that can be used to build a seven-country market forecast based on Decision Resources’ patient-based market models. Enhancements available in the electronic format include: key tables and figures listed under separate drop-down menus; quantitative tables that can be downloaded into Microsoft Excel; robust graphics; a Key Findings page for each chapter summarizing key points; search capability within a report; and chapter- and report-level easy printing options. The electronic interface offers users easier navigation throughout reports, a robust search capability, and easy printing options. Follow up C3i Inc., Morristown, N.J., offers global customer relationship management support services. For more information, visit c3i-inc.com. DataLabs Inc., Irvine, Calif., is a developer of Web-based applications for clinical development. For more information, visit datalabs.com. Decision Resources Inc., Waltham, Mass., offers market-research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. For more information, visit decisionresources.com. Dendrite International Inc., Bedminster, N.J., enables sales, marketing, clinical, and compliance solutions for the global pharmaceutical industry. For more information, visit dendrite.com. easyRegDocs, Charlottesville, Va., is a regulatory document outsourcing and management company serving both clinical research sites and pharmaceutical companies. For more information, visit easyregdocs.com. FFF Enterprises Inc., Temecula, Calif., delivers solutions in biopharmaceutical management and distribution, health-information management, and consumer healthcare services. For more information, visit fffenterprises.com. Galt Associates Inc., Sterling, Va., provides evidence-based drug-safety and risk-management solutions that integrate the expertise of medical and scientific personnel with innovative technologies. For more information, visit drugsafety.com. International Medical News Group, Morristown, N.J., publishes 10 medical newspapers for physicians. For more information, visit imng.com. Lathian Systems Inc., Plymouth Meeting, Pa., develops online promotional and educational solutions to help life-sciences companies improve customer relationships, enhance product education, and increase sales. For more information, visit lathian.com. Model N, South San Francisco, Calif., offers an integrated suite of revenue-management solutions for life-sciences companies. For more information, visit modeln.com. Perceptive Informatics Inc., Waltham, Mass., a wholly owned subsidiary of Parexel International Corp., develops and licenses technologies to support the drug-development process. For more information, visit perceptive.com. The Pharmaceutical Institute, Raleigh, N.C., provides specialized knowledge for pharmaceutical and biotechnology professionals. For more information, visit pharmainstitute.com. Phoenix Data Systems, King of Prussia, Pa., provides electronic data capture technology and data-management services for global drug development. For more information, visit phoenixdatasystems.net. Siperian Inc., San Mateo, Calif., offers master data integration and management software platforms. For more information, visit siperian.com. StayinFront Inc., Fairfield, N.J., is a global provider of enterprisewide customer relationship management (CRM) applications, decision-support tools, and e-business systems. For more information, visit stayinfront.com. Wolters Kluwer Health, Conshohocken, Pa., a division of Wolters Kluwer, is a provider of information for professionals and students in medicine, nursing, allied health, pharmacy, and the pharmaceutical industry. For more information, visit wkhealth.com.

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