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Thomson Scientific Expands Pharmaceutical Regulatory Intelligence Coverage
Thomson Scientific announces that three new country modules, India, Israel, and Turkey, are now available in IDRAC, the global pharmaceutical regulatory intelligence database. IDRAC is recognized by regulatory professionals as a leading authority in global regulatory intelligence. Updated weekly, the database brings together all of the information needed to monitor regulatory requirements in 47 countries and regions, including the three newly added areas. India is emerging as a preferred destination for pharmaceutical industry activities. The India module contains both regulatory and explanatory documents, including consolidated versions of main acts and rules and comprehensive follow up of amendments to this legislation, as well as the main regulatory guidelines and government policies. The Israeli pharmaceutical market is rapidly expanding. It is the home of leading generic companies, and pharmaceutical companies have shown a growing interest in conducting clinical trials in Israel. The Israel module provides current or consolidated versions of the main texts ruling the pharmaceutical profession in Israel and the main guidelines, as well as explanatory documents covering all regulatory aspects of drug development, registration, and marketing. Turkish legislation on the registration of medicinal products complies with the European Directive 2001/83/EC, and the Turkey module includes all relevant regulations. Explanatory documents in the Turkey module cover Turkish legislation and main issues related to medicinal products registration, product information, clinical research, quality assurance, pharmacovigilance, advertising, pricing and reimbursement, and generics. The comprehensive drug regulatory information in IDRAC is designed to help pharmaceutical companies adapt to a constantly changing regulatory environment, says Claude Basset, Managing Director of IDRAC, Thomson Scientific. MDL Isentris 2.0 Offers R&D Advantage Elsevier MDL has unveiled an upgrade to the MDL Isentris system for integrating information and software applications into scientists’ workflows. MDL Isentris 2.0 has hundreds of new capabilities and demonstrable performance improvements that give pharmaceutical, biotech, and life-sciences organizations the ability to improve R&D productivity through better data management, lowered cost of ownership, faster workflow processes, and easier information access and reporting. New features include a visual reaction planner that offers scientists better day-to-day workflow support. Standardized development tools make it easy for organizations to customize systems to meet their needs. Isentris can support hundreds of simultaneous users on a single mid-sized server. It is designed to handle massive loads, diverse data types, and the pressure of global R&D networks. Isentris lets scientists search multiple databases with a single query; sophisticated searches can be saved and reused and personal data views can be created without IT assistance. Scientists can find information faster, explore structure-activity relationships, collaborate, pursue hypotheses, and gain insights for informed intelligent decisions. MDL Isentris 2.0 features hundreds of new capabilities and demonstrable performance improvements that give pharmaceutical, biotech, and life-sciences organizations the ability to improve R&D productivity. More Efficient Communications Tools for Pharma Companies Thomson Healthcare has enhanced the PDR.net Website and introduced new tools that help pharmaceutical companies communicate with prescribers with greater efficiency and through targeted, integrated campaigns. These tools, which also include the PDA-based Thomson Clinical Xpert application, give the more than 240,000 healthcare professionals in Thomson’s electronic audience faster access to medical and drug information tailored to their practice needs. In total, Thomson can help pharma companies reach more than 675,000 prescribers in the United States. PDR.net now includes 19 specialty resource centers. Each resource center covers seven to 12 of the most common medical conditions within each specialty and includes multidrug interaction checkers, medical news feeds, conference information, practice-trends summaries, and medical Xpert Alerts. PDR.net is the first physician portal to deliver expert-authored disease diagnosis and treatment information from Micromedex, a trusted source that also provides the evidence-based medical libraries used in more than 86% of U.S.-based hospitals. Condensed versions of these same data sets are available via Clinical Xpert, which gives physicians and other prescribers clinical updates, calculators, and drug interaction checkers at the point of care. PDR.net also features the largest online database of FDA-approved pharmaceutical label information from the Physicians’ Desk Reference, including information on more than 4,000 brand-name drugs. The drug information on PDR.net includes groupings by drug class within a given medical specialty. Members of PDR.net can download Thomson Clinical Xpert, a PDA-based medical information application for Palm and Windows-based handhelds. Access is free to U.S.-based physicians, dentists, physician assistants, nurse practitioners, and medical students and residents. PDR.net maps Thomson’s drug and treatment content to the way prescribers prefer to access and interact with medical information, says Kevin Sanborn, Executive VP, Thomson Healthcare. PDR.net and Thomson Clinical Xpert give physicians the trusted information they need, when they need it, and via the online or handheld technologies that they choose to use. Icon Central Laboratories Launches Remote Data Access Tool Icon Central Laboratories has released ICOLabs, a remote data access tool for pharmaceutical and biotechnology clients. The ICOLabs product is a secure, completely Web-based application that incorporates a new digital dashboard feature that enables users to readily access study indicators, as well as custom reports. In addition, the system offers newly designed test result trending with numeric or graphic displays for an individual study subject or user-designated group of subjects. The tool provides point-and-click access to laboratory reports and investigator information, site-specific kit inventory information, and detailed reports pertaining to long-term specimen storage and shipments. The ICOLabs product is a secure, completely Web-based application that incorporates a new digital dashboard feature that enables users to readily access study indicators. CME Outfitters Unveils Web Portal for Neuroscience Professionals CME Outfitters has launched neurosciencecme.com, a Web portal for clinicians, researchers, and educators with an interest in healthy brain function. The Website integrates the key clinical areas that comprise the neurosciences by creating a central resource offering disease-specific clinical knowledge centers on schizophrenia, bipolar disorder, depression, ADHD, alcohol use disorders, and sleep and wake medicines. New clinical knowledge centers are rolled out on a regular basis. Other site offerings include certified multiformat educational activities, journal scans and abstracts, case vignettes, online testing and certificate processing, podcasting, and clinical-trial directories. Content for neurosciencecme.com is developed in close collaboration between the CME Outfitters Medical Resources Group and the CMEO Clinical Review Board, a panel of credentialed neuroscience specialists from top academic institutions across the United States. The site is supported by a biweekly opt-in HTML newsletter, neuroscienceCME Clinical Compass, which provides excerpts from the clinical knowledge centers, updates of interest to the neuroscience community, and announcements on new educational offerings. The current subscriber base is more than 53,000 healthcare professionals with an interest in the neurosciences. Clinical Compass augments the educational mission of neurosciencecme.com by providing readers with a mechanism for participating in needs assessment surveys and other feedback tools. This input is used to influence the information and resources offered at the site and to align that content with the stated needs of the users. In this way, the identification of knowledge and performance gaps is encouraged and then those gaps are filled with relevant certified education at neurosciencecme.com. CME Outfitters recognized the need for an online resource, and we built the portal to meet our high standards for strong, validated content coupled with a memorable user experience, says Christopher Perez, CME Outfitters’ Managing Partner in charge of accreditation and communications. Liquent InSight Takes Regulatory submission Publishing to a New Level The latest version of Liquent’s regulatory submission software enables pharmaceutical companies to create, manage, and publish regulatory submissions in both paper and electronic format using a single software application, saving critical time in the drug pipeline. With InSight Publisher 3.5, regulatory professionals can produce an electronic format, as well as a paper submission from a single assembly, using the same thin-client application that also is integrated with the rest of the InSight Suite. InSight Publisher 3.5 is built on the same platform as InSight Manager, which offers registration management and submission tracking capabilities. The entire platform is adaptable to many different organizational processes and designs, including centralized and decentralized publishing. The Liquent InSight suite is a fully integrated regulatory information management platform, which allows our clients to maximize the business benefit of reusing regulatory information while increasing compliance, says Rick Riegel, VP and General Manager, Liquent. Bio-Optronics Launches clinical trial management system Bio-Optronics has launched Clinical Conductor, a Web-based clinical trial management system (CTMS) designed for physicians’ offices, research centers, and academic medical centers. Clinical Conductor, an enterprise solution for clinical research, manages a research organization’s entire operations, including studies, staff scheduling, visit scheduling, treatment tracking, finances, workload planning, recruitment, marketing, internal communications, site calendars, and more. The financial section of Clinical Conductor is a powerful tool that analyzes opportunities presented and reviews revenue and profits expected for prospective studies. Clinical Conductor is the most powerful CTMS available and at the same time, it’s affordable, easy to use, and scalable, says Bio-Optronics President Mike Kamish. Onset Releases Software for 21 CFR Part 11 Compliance Onset Computer has released the latest version of HOBOware Pro data logger software. Version 2.3 helps pharmaceutical and biotechnology companies comply with the FDA’s 21 CFR Part 11 regulations by allowing quality assurance managers, shipping managers, and others to detect when data files have been tampered with and ensure that current data files match actual data originally recorded by HOBO data loggers. HOBOware Pro 2.3 supports a broad range of HOBO data loggers, which can be used to measure and record temperature, relative humidity, and other environmental conditions in pharmaceutical production facilities, incubators, freezers, warehouses, and transport vehicles. It is available in both PC and Macintosh versions. HOBOware Pro 2.3 supports a broad range of HOBO data loggers, which can be used to measure and record temperature, relative humidity, and other environmental conditions. Sheila Greco’s Hosted Application Provides Accurate, Phone-Verified Data Sheila Greco Associates’ (SGA) ExecutiveTracker for salesforce.com allows subscribers to find the industry’s largest and most accurate database of mid- and senior-level executive contacts across all job functions. The tool also easily imports these valuable prospects and candidates into the users’ salesforce.com application. SGA ExecutiveTracker features more than 270,000 names from the 6,200 top public and private U.S. companies across all industries and includes the hard-to-find, mid-management executives in functions, such as human resources, finance, marketing, research and development, information technology, manufacturing, accounting, compliance, sales, procurement, consulting, and purchasing. The data supporting SGA ExecutiveTracker is phone-verified and updated frequently without outsourced or third-party assistance. SGA Executive Tracker features more than 270,000 names from the 6,200 top public and private U.S. companies across all industries. Bio-Optronics, Rochester, N.Y., is a workflow solutions company providing cost-effective software solutions. For more information, visit bio-optronics.com. CME Outfitters LLC, Rockville, Md., is an independent provider of best-in-class CME and multidisciplinary continuing education for healthcare professionals. For more information, visit cmeoutfitters.com. Elsevier MDL, San Ramon, Calif., part of Reed Elsevier Group Plc., provides informatics, database, and workflow solutions that accelerate successful scientific R&D. For more information, visit mdl.com. Icon Central Laboratories, a division of Icon Plc., Farmingdale, N.Y., is a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical-device industries. For more information, visit iconclinical.com. Liquent, Philadelphia, offers regulatory software solutions, information products, and related services for the life-sciences industry. For more information, visit liquent.com. Onset Computer Corp., Bourne, Mass., is a supplier of battery-powered data loggers. For more information, visit onsetcomp.com. Sheila Greco Associates LLC, Amsterdam, N.Y., provides executive contact information to sales, marketing, recruiting, and human resource professionals. For more information, visit sheilagreco.com. Thomson Healthcare, Montvale, N.J., part of The Thomson Corp., provides information to healthcare professionals. For more information, visit thomson.com. Thomson Scientific, Philadelphia, part of The Thomson Corp., provides electronic workflow solutions. For more information, visit scientific.thomson.com.