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etrials Unveils New Version of EDC Solution

etrials Worldwide has unveiled EDC 2.0 solution. Combining more than 10 years of market validation and customer deployments, the newest solution builds upon existing Web-based software as a service (SaaS) solution for collecting, managing, and analyzing real-time clinical-trial information. EDC 2.0 was designed to simplify study deployment, provide more function and design control, enhance user experience and workflow, and offer powerful reporting and analytics capabilities. Some of the highlights of EDC 2.0 include: embedded administrative tools for easier user, site, and study management; role- and permission-based configurations; intuitive design and navigation to enhance user experience; configurable functionality (on/off) to support different study types; and automated workflow to optimize common and frequent tasks. As with all etrials’ solutions, EDC 2.0 can be fully integrated with other products, including interactive voice response (IVR) and electronic patient diaries (eDiary). EDC 2.0 also can incorporate third-party data (i.e., external lab and safety data), eliminating costly and time intensive data entry. EDC 2.0 represents the next evolutionary step etrials is taking to provide our customers with the most advanced integrated platform for managing all aspects of their clinical trials, says John Cline, CEO, etrials. Oracle Releases New Version of Siebel CRM Application Oracle has released Siebel CRM Release 8, which enables customer-driven business transformation for real-time insights at the moment of customer interaction and accelerates revenue growth through better-informed decisions. Delivered as part of Oracle’s Applications Unlimited program, Siebel 8 offers users a choice of multiple deployment options, ease of manageability, and low-cost integration. With certification with Oracle Fusion Middleware, Siebel 8 provides comprehensive support for Service-Oriented Architectures (SOAs) and out-of-the-box Web services-based integration. This simplifies integration between Siebel and other applications and services and accelerates Web-based application development. Additionally, Siebel 8 provides ongoing, heterogeneous support for non-Oracle technology to help increase the value of existing IT investments and prevent vendor lock-in. Key usability and other enhancements to Siebel 8 include: Siebel Task-Based User Interface, which extends business process automation directly to the point of user interaction; Change Business Processes in Real Time, which enables line-of-business personnel to create and change business rules and processes using a declarative, drag-and-drop environment that requires no coding, all in real time; expanded Web services support provides a standardized, SOA-enabled means to compose cross-application business processes that span business areas, technologies, and data stores. Siebel 8 delivers extensive new pre-built, highly scalable Web services for critical CRM business processes and components. Siebel 8 offers users a choice of multiple deployment options, ease of manageability, and low-cost integration. CMPMedica Expands Web Service with Free Primary-Care Search Engine CMPMedica has launched its second vertical search engine, or specialty-specific search engine, through SearchMedica.com, a free Web-based service that connects physicians and other medical professionals to credible, medical Websites, online journals, and other clinical resources. More than 6,000 physicians were polled to share their opinions on the major search engines; most found there were too many irrelevant results. SearchMedica.com addresses this “consumer clutter” problem by only indexing reliable medical information, approved for inclusion by medical editors and a physician editorial board. SearchMedica organizes results into categories, such as practical articles and news, research reviews and editorials, evidence-based articles and meta-analyses, practice guidelines, clinical trials for patients, continuing medical education, and alternative-complementary medicine. In each of the SearchMedica vertical search engines, clinicians receive a specialist’s view of the Web and an easy-to-use interface. Continuing medical education offers information about course work and online continuing medical education opportunities. Healthcare professionals are encouraged to register to receive updates about new content and tips on how to use various advanced tools within SearchMedica. Most primary-care physicians of any age said they turn to the Internet for clinical information, says Cyndy Finnie, Senior Product Manager, SearchMedica, CMPMedica. Symyx Releases Electronic Lab Notebook software Symyx Technologies has released the Symyx Software Discovery Notebook version 4.0. Discovery Notebook is one of a series of Symyx Software offerings that includes electronic lab notebook (ELN) applications tailored to meet the specific needs and protocols of chemists in the discovery, process, analytical, formulations, and bioprocess functions. The latest version of Discovery Notebook features an easy-to-use interface for single and parallel experimentation, an advanced software developer kit, extensive searching and browsing capabilities, and a preloaded reaction template database containing 30,000 transformations. The new version includes a search panel that allows scientists to search within sets of prior results, and a multipanel layout eases browsing through experiment data. New usability enhancements include improved scientifically accurate calculator capabilities, drag-and-drop functionality, icon-based entry for facile data capture, and additional experiment property tabs. The new version of our Discovery Notebook represents the successful integration of several key acquisitions that Symyx has made, says Paul Nowak, Chief Operating Officer, Symyx. Medidata Releases Updated EDC Solution Medidata Solutions has introduced Medidata Rave 5.6, which incorporates broad, industrial-strength data management tools into its electronic data capture (EDC) platform. Building on Medidata Rave’s multiple language capabilities, scalability, and ease of use, Rave 5.6 offers life-science research sponsors performance improvements to clinical-trial processes and new tools for streamlining enterprisewide implementations. The requirement for a separate clinical data management system (CDMS) is diminishing because of sophisticated and evolving EDC technology. Medidata is moving in this direction with a single instance platform for collecting and managing clinical data. With Rave 5.6, Medidata has incorporated broad CDMS functionality into its EDC system. Medidata Rave 5.6 allows global clinical study teams to collaborate within a single system, without having to manage complex integrations and incur additional overheads for deploying and managing a separate CDMS database. As a result, sponsors are able to increase efficiency, reduce risk, and improve scale to handle any size or study phase. Medidata Rave 5.6 offers an array of new features and components ranging from edit checks to entire forms and visit structures. Other features, such as a global library, make available multiple studies through the reuse of previous studies or study elements and allow for the secure and controlled establishment of standards libraries that can be leveraged across enterprisewide e-clinical deployments. We have evolved our EDC product to include deep CDMS functionality, which enhances the user experience and productivity for the entire study team, says Glen de Vries, Chief Technology Officer, Medidata Solutions. RevolutionHealth.com Launches to help families manage healthcare Revolution Health Group has unveiled preview editions of its first two products: RevolutionHealth.com, a free online service that helps families take action to manage their healthcare and achieve their healthy living goals; and Revolution Health membership, which gives members access to premium health services. RevolutionHealth.com offers more than 125 free tools and online services that help people live healthier, from losing weight to determining what an ailment might be, to tracking one’s overall health progress. Three services are incorporated in RevolutionHealth.com including: • Revolution Health Centers: The Best Health Info on the Web, As Rated by You, which address the challenges created by the proliferation of Internet-based health content. Every article can be rated by users, with new information and links added by community members. • Revolution Ratings: By the People, For the People, gives people looking for doctors and hospitals free access to information presently available through subscription services. There also is a system of patient ratings, which gives patients a chance to rate their experiences with their providers and treatments, and provides consumers with access to those ratings. • Revolution Circles: Bringing Health into the Web 2.0 Era, which brings the concepts of social networking and Web 2.0 to health by providing community tools that enable patients and caregivers to connect with others who have similar challenges and interests, share ideas, and help each other. It’s time to use the power of the Internet to reform healthcare with a ‘people-powered’ approach thereby giving parents, patients, and caregivers all of the tools they need to manage their healthcare needs and live healthier lives, says Steve Case, Cofounder of Revolution Health Group. AccentHealth Now Carries Discovery Health Programming AccentHealth, a health TV programming service that provides health and wellness content to more than 10,000 physician’s offices across the country, now features a customized block of Discovery Health’s original programming initially focused in the areas of early childhood development and healthy cooking. Senior Medical Contributor for Discovery Health Dr. Mehmet Oz will join the Discovery programming block as host later this year providing viewers with valuable health and wellness information through AccentHealth waiting-room services. Discovery Health joins AccentHealth’s current schedule of programming with content produced by CNN and hosted by Dr. Sanjay Gupta and Robin Meade. Through this partnership, Discovery Health continues its mission to reach consumers where and when they need reliable and targeted information about health and wellness, says Len Tacconi, President, Discovery Health Media Enterprises. We are happy to expand our list of programming partners to include Discovery Health for the health and wellness content they can provide, says Richard Ruth, CEO, AccentHealth. IMS Health Enhances Next-Generation Prescription Services IMS Health has launched Next-Generation Prescription Services, a large-scale enhancement to its core prescription offerings in the United States. With this implementation, the company’s industry-standard information services — IMS National Prescription Audit, IMS Xponent, and IMS PlanTrak — become significantly more powerful to help clients and researchers study the use and effectiveness of pharmaceutical products and to address increasingly complex market dynamics. Next-Generation Prescription Services provide more accurate, robust, and timely insights about evolving U.S. prescription trends. Incorporating patented and patent-pending methodologies, as well as product-level projections, the company now delivers precise product-level insights on all pharmaceutical products, including those with specialty distribution profiles. In addition, information is consistent across time periods and geographic views. New insights within existing IMS prescription offerings include new data elements, such as patient age and gender, NDC/pack/flavor, and copayment; integration of longitudinal metrics, such as national patient counts, new therapy starts, new-to-brand prescriptions, switching behavior, restarts, and add-on therapies; and enhanced long-term care projections, with the market fully projected on a weekly and monthly basis for subnational applications. IMS’s Next-Generation Prescription Services is a game-changing initiative that sets a new standard for market measurement, says Pam Sauerwald, VP, Portfolio Optimization, IMS Americas. ISI Solutions Platform Enables Compliance With Worldwide Regulatory Standards Image Solutions (ISI) has migrated its regulatory product suite into the ISI Solutions Platform built on Microsoft’s .NET Framework, providing companies with one flexible integrated platform to manage, develop, review, and publish electronic submissions. The platform enables companies to rapidly accommodate changes in business needs and differing regional requirements. ISI’s Solutions Platform supports an interconnected and interoperable set of applications that rapidly connect systems, people, and data across the drug-development life cycle to obtain relevant documentation and publish eCTD and CTD compliant submissions. The products can be configured to publish a submission in various formats, including paper, eCTD, non-eCTD electronic submissions (NeES), and proposed standards such as regulatory product submissions (RPS). Phase Forward Introduces Pharmacovigilance tool Our goal with this release is to make the WebVDME product even more flexible and intuitive, says Chan Russell, President of Phase Forward’s Lincoln Technologies safety division. Phase Forward has released WebVDME 6.0, its strategic pharmacovigilance and signal management product. The new release includes more tools and features for discovering and investigating signals in greater depth, exploring varied combinations of factors that trigger adverse events, and simplifying analysis of safety data. WebVDME is a visual data mining environment that provides quantitative data analysis and incorporates a signal management module (WebVDME Signal Management). WebVDME 6.0’s new features include: custom terms, extended logistic regression and expanded query support, enhanced query wizard and library capabilities, and expanded product support of multivariate Bayesian logistic regression. Health Market Science Offers Solution for Meeting State Marketing Compliance Regulations Health Market Science has launched a new data integration solution for pharmaceutical companies. Health Market Science has launched a new data integration solution for pharmaceutical companies to meet state compliance initiatives. HMS Compliance Solutions was developed to address the massive data integration challenges pharmaceutical companies will face in the wake of new U.S. state regulations. An increasing number of states, including California, Minnesota, Maine, and West Virginia now require pharmaceutical companies to report marketing, entertainment, and sales promotion expenses and/or pricing while enforcing caps on annual spending by provider. The solution combines matching technology, developed specifically for healthcare provider data. Follow up AccentHealth, New York, a division of Ascent Media Group, is an integrated health media company offering advertisers multiple consumer touch points in physician waiting rooms. For more information, visit accenthealthmedia.com. CMPMedica, Darien, Conn., provides healthcare information and education to primary-care physicians, specialists, pharmacists, and patients around the world. For more information, visit cmpmedica.com. Discovery Health Media Enterprises, Silver Spring, Md., a part of Discovery Communications Inc., includes the Discovery Health and FitTV television networks and online assets. For more information, visit discoveryhealth.com. etrials Worldwide Inc., Morrisville, N.C., is a provider of e-clinical software and services to CROs as well as pharmaceutical, biotechnology, and medical-device companies. For more information, visit etrials.com. Health Market Science (HMS), King of Prussia, Pa., is a manufacturer of healthcare provider data and serves all aspects of healthcare, including pharmaceutical manufacturers, biotech companies, device manufacturers, payers, providers, and pharmacy chains. For more information, visit healthmarketscience.com. Image Solutions Inc. (ISI), Whippany, N.J., provides submissions solutions, process services, and consulting to life-sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. For more information, visit imagesolutions.com. IMS Health Inc., Plymouth Meeting, Pa., is a provider of market intelligence to the pharmaceutical and healthcare industries. For more information, visit imshealth.com. Medidata Solutions, New York, is a global provider of electronic clinical data capture, management, and reporting solutions. For more information, visit mdsol.com. Oracle Corp., Redwood Shores, Calif., is an enterprise software company that manages, shares, and protects information. For more information, visit oracle.com. Phase Forward Inc., Waltham, Mass., is a provider of integrated data management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. Revolution Health Group LLC, Washington, D.C., creates products and services that empower people by putting them at the center of the health system. For more information, visit revolutionhealth.com. Symyx Technologies Inc., Santa Clara, Calif., develops electronic lab notebook and execution and analysis software, lab automation, and breakthrough materials technology dedicated to helping customers maximize the effectiveness and success of their R&D programs. For more information, visit symyx.com.

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