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NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES
Octagon Research Solutions Inc. has unveiled ViewPoint for Document Management, a solution that com bines existing Octagon document management, authoring tem plates, and document standards in a preconfigured environment designed to support enterprise authoring processes in the lifesciences industry. ViewPoint for Docu ment Management incor porates document stan dards from Octagon’s eCTD JumpStart offering and Start ingPoint submission author ing templates.By mobilizing these pro cesses through the existing ViewPoint environment and using capabilities such as checkin/checkout and ver sion control, ViewPoint for Document Management offers the structure and standards required to support the entire document life cycle, from authoring through submission. ViewPoint for Document Manage ment can be deployed through View Point’s traditional install/implementa tion model, as well as a new hosted model that eliminates installation, hardware, and validation costs, and provides a connection to Octagon resources. Octagon Research Releases DOCUMENTMANAGEMENT SOLUTION Wolters Kluwer Health and Isabel Healthcare have integrated Wolters Kluwer’s online clinical decision support tool, Clineguide, with the Isabel diagnosis reminder system, offering clients comprehensive access to evidencebased medicine for both diagnosis and treatment. Clineguide provides integrated content from Ovid, Facts & Comparisons, and Lippincott,Williams andWilkins to enable clinicians to check facts,review evidence, determine treatment,and check drug interactions. Isabel is a validated,Webbased diagnosis decision support and knowledge mobilizing system designed to help reduce and manage diagnosis error at the point of care. “Improving the consistency and quality of patient care while saving time for busy clinicians and pharmacists is a fundamental benefit of Wolters Kluwer Health’s pointofcare products,”says Arvind Subramanian, president and CEO of Wolters Kluwer Health Clini cal Solutions. Partnership Provides Access to INTEGRATEDMEDICALDATA First Consulting Group (FCG) has introduced FirstPoint, a costeffective, Microsoft Office based enterprise content management (ECM) solution. FCG also offers FirstPoint preconfig ured with industry best practices to meet the needs of an entire lifesciences organization, from R&D to marketing and sales. In addition to managing regulated content, FirstPoint’s rulesbased workflow engine can facilitate collaborative processes across the many functions often overlooked in ECM deploy ments, such as legal, finance, and human resources, as well as secure external collaboration. According to Jeff Klein,VP of global solution sales and product development for FCG’s life sciences practice, the benefits offered by FirstPoint across the enterprise and its associated network of partners include: . Microsoft Officebased user experience for ease of use, greater collaborative participation, and increased productivity. . A system compliant with FDA 21 CFR Part 11, including audit trail and electronic signa tures. . Established industry bestpractice content type and taxonomy model, and automated, rulesdriven lifecycle and document processing. . Easily configurable workflows for document collaboration and content organization and assembly for regulatory processes. . Federated metadatadriven approach to harmonize content management usage across multiple repositories. FCG Releases ENTERPRISE CONTENTMANAGEMENTTOOL PharmaVigilant Introduces TRIAL MASTER FILE SYSTEM PharmaVigilant’s recently launched IVault electronic trial master file system provides clini cal researchers with a solution that incorporates both electronic data capture (EDC) files and trial master files, which are often recorded on paper. IVault is designed to identify document types at the site and direct them to the proper trial master file folders.This increases the value of onsite monitoring visits, while reducing the time and associated costs. Site docu ments are available to all users; but subject docu ments are selected and deidentified before being made available to sponsor users within the system. This creates an electronic fence for subject informa tion that prohibits it from being uploaded to the sponsor.The system has been initially scaled to store up to 1 million documents, enabling companies of all sizes to use the system. IVault also incorporates source documents into the system,enabling remote monitoring for the first time within one system. “Although many companies have mandated EDC for all trials, the other half of the submission, trial master files, is paperbased,”says James DeSanti,CEO of PharmaVigilant. “There can’t be an endtoend solution unless both sides of the submission equa tion are electronic.” In other product news, PharmaVigilant has launched the latest version of its IWarehouse clinical data storage solution. IWarehouse 1.5 incorporates import utilities that enable data sets from different formats, including Excel, SAS, and CDISC, to be easily validated and uploaded into the company’s data warehouse. It also allows data from multiple sources to be combined and viewed within the same report. IVault is designed to identify document types at the site and direct them to the proper trial master file folders. Wolters Kluwer Health and Isabel Healthcare partner to provide evidencebased medicine access. ViewPoint for Document Management is a perfect fit for small organizations that need authoring capabilities, says Jim Walker, Chairman and CEO of Octagon Research Solutions. The market is demanding a way to simplify content management especially in terms of usability, platform consolidation, and collaboration, says Jeff Klein, VP of Global Solution Sales and Product Development for FCG’s LifeSciences Practice. 58 F e b r u a r y 2008 PharmaVOICE 0208issue FINAL 1/18/08 5:36 PM Page 58 Emedia # Pharmaceutical and medical professionals can now use their BlackBerry smartphones to access the Epocrates Rx drug and formulary reference guide produced by Epocrates, San Mateo, Calif. This version of Epocrates’ software gives pharmaceutical representatives, physicians, and other healthcare professionals remote access to drug information and realtime clinical updates through their BlackBerry devices. For more information, visit epocrates.com. # Invivodata Inc., Pittsburgh, has introduced a new version of its electronic patientreported outcomes (ePRO) management system.The EPX ePRO Management System,Version 5.0, enables sponsors, monitors, and site personnel to more effectively manage ePRO activities related to their clinical studies.The Webbased system allows the uploading of ePRO data collected from the company’s DiaryPRO and SitePRO solutions, giving users realtime access to PRO data collected throughout the clinicaltrials process. Through this new version, trial sponsors and monitors can capture more accurate and reliable data and gain quick insights into trial progress, allowing them to easily determine whether patients are complying with trial protocols. For more information, visit invivodata.com. # Phase Forward Inc., Waltham,Mass., has introduced a new version of its Web submission data manager product.The WebSDM 2.6 software reads data from Phase Forward’s InForm integrated trial management electronic data capture (EDC) product, allowing data managers to better understand the overall data quality of records under review and detect anomalies and trends to support safety analysis. Other capabilities include validation for use on 64bit platforms and Oracle’s Database 10g, and Web Services API to enable automated data loading and improved integration with external data repositories such as Janus. For more information, visit phaseforward.com. # Trialstat Corp., Ottawa, has added new features to its ClinicalAnalytics 4.0 ondemand electronic data capture (EDC) platform that further enhance performance, reporting capabilities, and ease of use.The system now offers contract research organizations and biopharmaceutical companies sophisticated graphicsbased reporting tools, automated post data entry validation, and optimized study management functionality through its secure browser interface. By combining enterprise sophistication with draganddrop simplicity, customers can accelerate the deployment, management,and analysis of their clinical research data. For more information, visit trialstat.com. EUPGRADES AND ENHANCEMENTS DRUGLOGIC INC., Reston,Va., develops analytical tools for managing risks related to drugsafety issues. For more information, visit druglogic.com. FIRST CONSULTING GROUP INC., Long Beach,Calif., provides outsourcing, consulting, and systems integration for healthcare, pharmaceutical,and other lifesciences organizations throughout North America,Europe,and Asia. For more information, visit fcg.com. ISABEL HEALTHCARE INC., Reston,Va., offers a Webbased,diagnosis decision support system.For more information, visit isabelhealthcare.com. Follow up OCTAGON RESEARCH SOLUTIONS INC., Wayne,Pa.,offers a suite of regulatory, clinical, process, and IT solutions to the lifesciences industry for the electronic transformation of clinical R&D.For more information, visit octagonresearch.com. ORACLE CORP.,Redwood Shores,Calif., is an enterprise software company that manages, shares, and protects information.For more information, visit oracle.com. PHARMAVIGILANT,Westborough,Mass., offers solutions to address the complexities of global clinical research. For more information, visit pharmavigilant.com. TATA CONSULTING SERVICES,Mumbai, India, provides pharmaceutical companies with IT and outsourcing services and business solutions that include clinical data management, statistical analysis, scientific communication,and drug safety and pharmacovigilance.For more information, visit tcs.com. WOLTERS KLUWERHEALTH, Conshohocken,Pa.,a division of Wolters Kluwer,provides information for professionals and students in medicine, nursing, allied health, pharmacy,and the pharmaceutical industry. For more information, visit wkhealth.com. Tata Consultancy Launches PHARMACOVIGILANCE SOLUTION Safety in a Cap sule, the latest drug safety and pharma covigilance solution from Tata Consultan cy Services ( TCS), incorporates soft ware from Oracle and technology from DrugLogic to better enable pharmaceuti cal manufacturers to identify and monitor adverse drug events and ensure compli ance with increasingly stringent regulatory require ments. Safety in a Capsule combines TCS’s knowledge process outsourcing (KPO) services with the Siebel Contact Center Integration Pack for Oracle’s Adverse Event Reporting System, as well as DrugLogic’s Qscan, a workflowbased analytical tool for identify ing, analyzing, and resolving drugsafety risks. The integrated solution streamlines and monitors safety and surveillance processes followed by pharmaceu tical and biotechnology companies during a drug’s life cycle to minimize risks and costs. It also leverages safety analytics for early insight into a drug’s safety profile and rapidly analyzes patterns in adverse events that could indicate emerging drugsafety risks both pre and postmarket. “The solution will help improve drug safety, min imize risks, and reduce costs while adhering to good pharmacovigilance practices,”says J. Rajagopal,exec utive VP and global head,consulting, for TCS’s lifesci ences and medicaldevice practice. Safety in a Capsule combinesTCS’s knowledge process outsourcing (KPO) services with the Siebel Contact Center Integration Pack for Oracle’s Adverse Event Reporting System. 59 PharmaVOICE F e b r u a r y 2 008 0208issue FINAL 1/18/08 5:36 PM Page 59