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

CIS Launches Pharma Compliance Exchange Website Compliance Implementation Services (CIS) recently released the Pharma Compliance Exchange (PCX), a new subscription-based source for government guidance documentation. For the first time, government program publications and guidance are available in one convenient Website, cis-pcx.com. The PCX is centralized, organized, maintained, simple, and customizable for all pharmaceutical manufacturers. CIS’s PCX centralizes and organizes published statutes, regulations, and guidance pertaining to government programs and statutory pricing. The online resource is a comprehensive, cost-effective, and convenient one-stop-shop for public information relevant to Medicaid, VA, 340B, Medicare Parts B and D, and Tricare. The Drug Rebate Agreement requires that pharmaceutical manufacturers maintain a library of the documentation from which their calculations were derived, which would include statutes, regulations, rules, and guidance. Yet few pharmaceutical companies have the time or the resources to create, organize, and maintain an adequate compliance library. Subscribers to the site also will be able to ask basic compliance questions and receive weekly updates on the newest changes to documentation. In addition, they will receive and be able to participate in a topical monthly newsletter, a publication devoted specifically to the government program audience. The PCX is centralized, organized, maintained, simple, and customizable for all pharmaceutical manufacturers, says Chris Cobourn, VP of Regulatory, Compliance Implementation Services. RapidTrials Releases Web-Based Learning Program RapidTrials has launched Conducting Successful Clinical Trials (CSCT), a multipart learning program that provides research sites with best practices for successful clinical-trial management. CSCT, a Web-based CME learning program, includes step-by-step instruction for assessing the feasibility of a study protocol featuring critical considerations for site logistics, patient recruitment, workflow, and budget management. CSCT is a cutting-edge program offering training in specific regulatory, business, and workflow issues often encountered by clinical-research sites. As a case-study based tool, CSCT provides users with real-world experience by working with the types of issues that they may face in any clinical-trial situation. The new, knowledge-based tool is designed for all levels of research staff and offers four category one continuing medical education (CME) credits to physicians. The program consists of four hours of Web-based training as a stand-alone program or used in parallel with a more comprehensive three-part program: overview of clinical research (manuscript); preparing for trials (Web-based); and implementation of trials (live course). SK&A Information Services Announces PrescriberPlus PrescriberPlus, a new product from SK&A Information Services, is designed to help healthcare sales and marketing executives identify and target physicians and other prescribers based on their prescribing habits. SK&A is able to link prescription-based decile data to physicians, nurse practitioners, physician assistants, and dentists. It maintains a database of practicing healthcare professionals at their business location and telephone verifies records in the database every six months to guarantee its accuracy. In addition to office address, PrescriberPlus data includes the name and title of the prescriber and the medical practice name. Phone and fax numbers are available. Prescribers can be selected by their specialty or their location. A feature of PrescriberPlus is the ability to identify the medical groups, group practices, health systems, and hospitals with which prescribers are affiliated, bringing all the decision-makers into clear view. Prescribers of a drug or class of drug are ranked in order of the volume of prescriptions written and then divided into deciles. Prescribers may be selected from the SK&A database by their decile rank for a specific drug brand, class of drugs, or by the total volume of prescriptions written. Updated quarterly, the database includes 525 therapeutic classes and more than 37,700 individual brands. Pharmaceutical, medical supply, and other companies require prescriber-level intelligence to better target sales and marketing efforts. Simulations Plus Extends Software Product Line Simulations Plus has developed a powerful method for generating new molecular structures for early discovery that is believed to provide a significant improvement to the task of finding good, new, drug-like molecules. By combining the new R-Table Exploder in ClassPharmer with the company’s ADMET Predictor software, chemists can now generate molecules with a high likelihood of hitting a target while also having acceptable ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) properties. The R-Table Exploder creates new molecular structures that use all possible combinations of fragments that were in at least one molecule at each location. This explosion generates new molecular structures that belong to the same high-activity class generated by ClassPharmer, because they all share the same common substructure. The importance of this approach is that the new molecules are very likely to be able to be synthesized. Relsys International Releases Risk-Management Tool Relsys International has released Argus Perceptive, a risk-management pharmacovigilance tool for the bio-pharma industry. Argus Perceptive, when combined with Argus Insight, builds on a comprehensive safety knowledge base to provide a proactive approach to pharmacovigilance. Analytical engines enable a real-time, auditable means for automated signal detection, analysis, documentation, and communication to provide risk-management support. Argus Perceptive integrates with analytical and visualization engines such as DrugLogic’s Qscan and Relsys’ Argus Insight. Sanket Agrawal, Relsys’ chief strategy officer, says passively monitoring adverse events is no longer appropriate. Argus Perceptive enables a holistic approach and forms the platform for further innovations. Argus Perceptive, when combined with Argus Insight, builds on a comprehensive safety knowledge base to provide a proactive approach to pharmacovigilance. Dorland Global Launches New Website Dorland Global has launched a new Website, featuring a blog by industry insider and Dorland Global Cofounder Harry A. Sweeney, who is well-known for his prolific writing and as a featured thought leader. In addition to Mr. Sweeney’s views and insights, the blog features guest diarists, including agency executives, clients, and colleagues in the healthcare communications industry. Dorland Global anticipates and welcomes visitor comments and encourages a dialogue about the constantly changing and challenging healthcare environment. The Website is engaging and easy to navigate and includes an interactive medical trivia game where visitors can challenge their healthcare knowledge. There is a section on career initiatives, where interested parties can submit their resumes directly to the agency. Dorland’s updated Website features the blog of industry thought leader Harry Sweeney. We are especially excited to be able to share Harry’s insights and inside-the-beltway FDA commentary with visitors to our site, says Rita Sweeney, President and CEO, Dorland Global Corp. Spoken Translation Unveils Interpretation Software Spoken Translation has unveiled Converser for Healthcare, a translation software tool that provides 24/7 live interpreting. The initial product is targeted to the healthcare market and provides Spanish-to-English and English-to-Spanish translation. The system allows people who do not speak the same language to hold broad health-related conversations in real time, without a human interpreter. Converser represents an advance in machine translation (MT) technology. The system provides reliable, bi-directional, wide-ranging translation via multiple interface modalities, including speech recognition. While Spanish is the first language released, other languages for the healthcare market are planned for later this year, including Chinese. Converser can run on tablet PCs or laptops. The initial product is targeted to the healthcare market and provides Spanish-to-English and English-to-Spanish translation. Zoomedia Releases Improved Thought-Leader Portal Zoomedia has launched an enhanced portal called Hype & Hope, which features original editorial content from industry thought leaders, a comprehensive event calendar, and video libraries. Content in Hype & Hope is provided to inform and support a robust debate around emerging issues in the life sciences, such as stem-cell and personalized medicine research. Hype & Hope provides news, events, editorials, stock indices, resources, and video and image libraries. Registered users can subscribe to XML feeds, rate editorials as hype or hope, receive weekly newsletters, and request participation in the portal’s invitation-only blog. Content in Hype & Hope is provided to inform and support a robust debate around emerging issues in the life sciences, such as stem-cell and personalized medicine research. Follow up Compliance Implementation Services (CIS), Media, Pa., is a consulting firm specializing in establishing a culture of compliance for pharmaceutical companies. For more information, visit cis-partners.com. Dorland Global Corp., Philadelphia, is a healthcare advertising agency offering a full range of communications services. For more information, visit dorland.com. RapidTrials, Wayne, Pa., is a specialty CRO for the pharmaceutical industry. For more information, visit rapidtrials.com. Relsys International Inc., Irvine, Calif., provides a complete systems solution for pharmacovigilance and risk management. For more information, visit relsys.net. Simulations Plus Inc., Lancaster, Calif., develops drug discovery and development simulation and modeling software. For more information, visit simulations-plus.com. SK&A Information Services Inc., Irvine, Calif., is a provider of healthcare information. For more information, visit skainfo.com. Spoken Translation Inc., Berkeley, Calif., provides commercial and custom solutions for automatic cross-lingual communication, and provides strategic and technical consulting services. For more information, visit spokentranslation.com. Zoomedia Inc., San Francisco, is a communications and marketing services agency for the life-sciences industry. For more information, visit zoomedia.com.

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