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E-Media New electronic and web-based applications, sites, and technologies NoInk Communications has released Pharma-SalesAccelerator, a new suite of applications specifically designed to improve productivity and increase performance of pharmaceutical sales organizations. NoInk partnered with Pedia-Med Pharmaceuticals Inc., a pharmaceutical company devoted exclusively to the health of children, to assist with the development of the new product line. “We currently have a powerful salesforce automation (SFA) solution deployed by medical companies across the country and a long history of solving mobile sales issues,” says Robert Compton, chairman and CEO of NoInk. “Our experience and expertise, blended with the PediaMed partnership, ensure our ability to address the specialized needs of pharma sales and the FDA regulatory requirements inherent to the process.” Pharma-SalesAccelerator can help pharmaceutical companies increase efficiency in the sampling process; better manage their ever-growing databases of physician contact information; meet the FDA’s stringent tracking and reporting requirements for product samples and distribution verification; increase sales productivity within large geographic territories; and improve sales performance in an increasingly competitive industry. NoInk has engineered its suite of applications from the sales rep’s perspective by directly addressing the daily needs of mobile pharmaceutical sales reps while providing for management’s review and the use of analytics. The company uses a field-tested product development strategy to “walk in the shoes” of its users before developing applications. NoInk’s Pharma-SalesAccelerator builds upon the company’s current mobile technology platform, which is being used by more than 3,000 medical-sales professionals. Its suite of applications include Account Manager, Field Communications, Sales Call Planner, Product Manager, Document Manager, Launch Booster, Event Manager, and Sample Manager. The Pharma-SalesAccelerator product line is designed to: meet Prescription Drug Marketing Act (PDMA) compliance requirements; reduce the administrative burden and risk of error associated with recording, rekeying, and tracking the whereabouts of product samples, physician signatures, and physician medical license numbers; integrate sales-call planning with marketing/sales plans of action; record and track marketing activity according to physician; support new product launches with greater accuracy and analytics; and provide pharmaceutical management with enhanced visibility and measurement metrics to improve sales, marketing, and sample planning. TheraDoc Inc. has released Clinical Alerts Assistant, a decision-support software knowledge module that helps clinicians improve patient safety and the quality of care by increasing awareness of real and potential issues while supporting the decision-making process. The Clinical Alerts Assistant leverages TheraDoc’s proven ability to integrate with multiple hospital information and ancillary systems and continually monitor the electronic medical record (EMR). Thera-Doc’s automated surveillance results in updated, relevant patient data, which the Clinical Alerts Assistant delivers to healthcare providers as actionable information supported by evidence-based knowledge in the form of intelligent alerts and reminders. “With the Clinical Alerts Assistant, TheraDoc delivers a greater breadth of actionable clinical knowledge to caregivers facilitating the clinical decision-making process and enabling them to significantly change the healthcare experience and outcome for each patient,” says Stan Pestotnik, TheraDoc president and CEO. TheraDoc’s Web-based technology and knowledge solutions are vendor-neutral to enable integration with a variety of hospital information and ancillary systems. Leveraging the information contained within ADT (admission/discharge/transfer), laboratory, and pharmacy systems, the Clinical Alerts Assistant alerts clinicians to early warning signs of relevant changes in a patient’s condition, enabling earlier intervention and providing the information caregivers need to respond. Acurian Inc. has released AcuScreen, a proprietary patient processing technology. This product is available for sponsors regardless of whether Acurian is involved as a recruitment vendor. Previously, AcuScreen was only available when a sponsor contracted with Acurian for patient-recruitment services. AcuScreen consists of two functional components that address issues around patient screening, patient tracking, and a sponsor’s visibility into its return on recruitment investment. The first component is the screener, which Acurian deploys simultaneously in both phone and Web formats and which provides study candidates with a choice of screening methods and facilitates a higher response rate. Tracking and reporting functionality is the second component. Sites use AcuScreen’s centralized reporting format to track patients from referral to resolution, and sponsors use the same tracking system to determine which investigators are performing and which may need assistance. “By offering AcuSreen irrespective of Acurian’s involvement in the patient-recruitment campaign, we are responding to an industry that is demanding consistency and accountability,” says Mark Eisenach, CEO of Acurian. “Sites are frustrated with referral quality that is dictated by different screeners, and sponsors have a very limited understanding of where their money goes. AcuScreen solves both of these problems quite easily.” AcuScreen enables a sponsor to drive all patient recruitment through a single platform, regardless of how many and what kind of recruitment vendors are involved. Study candidates respond to a patient-recruitment campaign through specially assigned toll-free numbers or Web URLs that uniquely identify each campaign, enabling sponsors to track their recruitment investments. AcuScreen filters candidates using the exact same screener and then becomes a tracking system when patients are referred to the sites. The AcuScreen platform is hosted at Acurian’s secure facilities, which enables sites and sponsors to leverage the solution without investing in hardware, software development, or professional services. Pharma-Sales Accelerator builds on our leading-edge mobile applications that have proven successful throughout the medical industry. With the Clinical Alerts Assistant, TheraDoc delivers a greater breadth of actionable clinical knowledge to caregivers. With the Clinical Alerts Assistant, TheraDoc delivers a greater breadth of actionable clinical knowledge to caregivers. DataLabs Inc. has released DataLabsXC version 3.1, a software suite for clinical development featuring support for the Clinical Data Interchange Standards Consortium (CDISC) operational data model (ODM) version 1.2. DataLabs is one of the first vendors to offer formal support for this standard as part of its product suite. “In addition to support for standard CDISC import and export features, DataLabsXC version 3.1 follows the CDISC standard for encoding and Web services to enable easier integration with a customer’s existing systems,” says James Langford, president and CEO of DataLabs. “Integration has been a major barrier to the adoption of technologies that can help improve the clinical-development process, and DataLabs is committed to breaking down this barrier through software that truly embraces standards.” “The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry,” says Rebecca Kush, Ph.D., president of CDISC. DataLabsXC version 3.1 includes a host of workflow enhancements, expanded Web services support, easy export utilities, and a customizable bridge product that enables the import of clinical data from fax and imaging information capture systems. The new software release also features user interfaces optimized for medical and field monitors. Unlike application service provider (ASP) models, DataLabs licenses DataLabsXC software directly to customers, offering the flexibility to adapt the software to unique specifications and conduct studies in a cost-effective manner. The DataLabsXC product suite includes: DataLabsXC Designer, a drag-and-drop clinical-study design tool using Microsoft Visio; DataLabsXC Clinical, a clinical-data management system with integrated Web-based data collection and trial management features; and DataLabsXC Connect, a standards-based connector toolkit enabling integration with external applications and legacy systems. Medicare Reform Advisor is an electronic newsletter that is designed to help physician practices, hospitals, pharmaceutical companies, managed-care organizations, state health officials and policy leaders, aging groups, Washington lobbyists, and healthcare attorneys understand and comply with the complex new rules and regulations as well as contend with the legal consequences of the new Medicare law. Each issue features news by industry, easy-to-understand explanations of complex new regulations coming out of the law, and specific strategies to help providers comply with it and learn any competitive advantages it may provide. HCPro’s editors also provide complete analysis of the new law and regulations that are related to drug reimbursement. “The Medicare Reform Advisor translates the 700-page law and the reams of regulations that will follow into simple action points,” says Suzanne Perney, publisher. “Our mission is to translate the often incomprehensible legalese of the Medicare law and regulations into plain English. Healthcare and pharmaceutical professionals can easily understand the regulations and make sure they are complying with the law.” A new version of Adis R&D Insight (R&DI), a research tool designed to give pharmaceutical marketers a leg-up in evaluating their competitors, has been released by Wolters Kluwer Health’s Pharma Solutions Division. The updated version is the first in a new class of research tools that makes it easy for users to analyze and evaluate large amounts of data at a single glance. Developed by Wolters Kluwer Health in partnership with AdvanTechnologies Inc., the new Adis tool uses proprietary modeling software to graphically represent key elements from the vast library of data within the industry-standard R&DI database. Graphics capabilities include the ability to create pie charts, bar charts, and tables, all of which provide explicit visual presentations of the analysis. When a trend or area of interest is identified, a user can drill-down to a deeper level, change groupings, and re-sort the data using new parameters. “We’ve taken the industry’s most in-depth pipeline drug database and made it even more powerful by adding a modeling tool that makes it easy for our customers to quickly gain a comprehensive view of the competitive landscape,” says John Monahan, president and CEO of Wolters Kluwer Health, Pharma Solutions Division. The new R&DI eliminates the need for users to export data and manipulate the information using external software. This ability reduces the time it takes to search and interpret the data. In some cases, where it previously took one to two hours to drill down and cull a subset of relevant information, now it takes 30 seconds or less. R&DI enables the user to analyze data in a variety of ways, including: aggregate groups of data from the R&D Insight data set, summarize and compare drugs across multiple parameters using a matrix, and export any data set to preformatted Excel spreadsheets. R&DI contains profiles for more than 16,000 drugs in development, each with a detailed literature review, a rating based on therapeutic value, and commercial intelligence from Lehman Brothers. “We’ve taken the industry’s most in-depth pipeline drug database and made it even more powerful.” HCPro’s editors provide complete analysis of the new Medicare law and regulations that are related to drug reimbursement. “DataLabsXC was built from the ground up with CDISC in mind,” says James Langford, President and CEO of DataLabs. SupplyScape has released SupplyScape Electronic Pedigree, a software solution that helps the pharmaceutical industry combat the growing problem of counterfeit drugs. The technology, which can be used to support the FDA counterfeit drug initiative, uses radio frequency identification (RFID) to build a custodian history, or pedigree, that traces each drug’s chain of ownership from the pharmacy back to the manufacturer. SupplyScape Electronic Pedigree is the first solution to comply with both the federal Prescription Drug Marketing Act (PDMA) and state drug pedigree laws to eradicate counterfeit drugs, by using the Electronic Product Code (EPC) and RFID industry standards already adopted by the U.S. Department of Defense, Wal-Mart, Procter & Gamble, Gillette, and other companies to make their supply chain operations more efficient. “SupplyScape Electronic Pedigree is the first technology that achieves both regulatory and business requirements,” says Shabbir Dahod, president and CEO of SupplyScape. “The benefit of this system is that while attacking a growing risk to patient safety, pharmaceutical companies can also save significantly by streamlining supply-chain management.” According to the FDA’s Counterfeit Drug Task Force, electronic pedigree using RFID tags to track and trace prescription drugs is a key technology in a multipronged strategy to safeguard the American drug supply. The number of counterfeit drug investigations by the FDA has quadrupled since 2000. Until now, preventing counterfeit drugs by providing accurate drug pedigrees has been complex and expensive for pharmaceutical wholesale distributors who typically carry more than 40,000 drug stocking units to supply pharmacies that fill more than 3 billion prescriptions annually. SupplyScape Electronic Pedigree detects whether wholesalers follow state custodian laws such as the Nevada regulation, which strictly limits sales between drug wholesalers to prevent counterfeiting. SupplyScape Electronic Pedigree is the first solution to comply with both the federal Prescription Drug Marketing Act (PDMA) and state drug pedigree laws. The Website is designed to reflect Valeant’s new strategic vision and to highlight its unique products and capabilities. Blue Diesel has developed a new corporate Website for Valeant Pharmaceuticals International, formerly known as ICN Pharmaceuticals. The name Valeant was selected to communicate the company’s transformation to an integrated global specialty pharmaceutical company. “We have made dramatic changes to our company over the past year that range from bringing on a new management team to restructuring our operations and staff to providing a more focused approach to our business,” says Wesley P. Wheeler, president of Valeant’s North American operations and global marketing. “With the launch of the new identity, communicating our values and mission to our key audiences is critical. The Website allows everyone from investors to prospective employees to easily access information about who we are and what we stand for.” Valeant’s site, valeant.com, features a R&D section that highlights its pipeline and a product section that provides details about its seven global products in the area of dermatology, infectious disease, and neurology. The site also features profiles of the management team, and provides access to news releases, financial reports, and other information for investors and the media. The company’s branding elements, including the new logo and the corporate colors, are integrated throughout the site. “Valeant has been through a tremendous evolution during the past year and is now on the path to an exciting new chapter in its history,” says John Racik, president and CEO of Blue Diesel. SciQuest Inc. has launched Sourcing Manager, the latest in the company’s suite of on-demand supplier relationship management (SRM) modules to help organizations achieve enterprisewide spend visibility. Leveraging technology from Ion Wave Technologies, procurement professionals can quickly create, issue, monitor, and award informal quotes and formal bid requests. “With Sourcing Manager, our customers are able to work more efficiently to capture and manage a significantly larger portion of their spend across organization, and use new bidding techniques to drive significant savings,” says Jamie Duke, chief operating officer at SciQuest.” Vendors can easily access the system to view and respond to bid opportunities. The traditional time-consuming processes of bid tabulation and inviting vendors are automated, freeing procurement professionals to focus on procurement instead of paperwork. Vendor registration and profile-management functions are provided to ease the administrative burden on the purchasing staff. Among Sourcing Manager’s features are an interactive bid release and supplier response, which reduces process time from weeks to days; attribute-based bidding for complex RFPs, which increases supplier response accuracy and captures complex award criteria in addition to price; sealed bid response encryption and complete audit trails, which ensure a high level of security; supplier self-registration, commodity classification, and profile management, which eases the administrative burden of supplier management; and automated bid tabulation. Everypath Inc. has introduced Everypath MTA 5.0, its next generation of mobile task automation (MTA) products. The new product enables mobile applications that automate sales, service, and supply-chain tasks. Everypath MTA 5.0 features multimode connectivity, enabling a new class of always-on mobile enterprise applications that blend real-time wireless access to corporate data with the ability to manipulate information stored locally on a handheld device. The product includes components for a wide variety of mobile tasks, such as activity management, detailing, order entry, inventory look-up, call reporting, and more. To address specific business process requirements, Everypath MTA application components can be configured to adjust task sequences, user interface, and functional requirements. A key design goal of each component is to leverage logic and data from existing applications rather than duplicating functionality by creating separate stand-alone applications. Everypath MTA 5.0 applications combine real-time (wireless) and store-and-forward (offline) interactions in a single software framework, reducing the cost and complexity of providing an always-on mobile user experience. For example, a mobile sales representative can retrieve customer contact information replicated onto a handheld device while looking up order status information located in a corporate database accessed using a real-time connection. Addressing one of the largest barriers to deploying new applications in the enterprise, Everypath MTA 5.0 introduces a MTA repository and life-cycle management capability. The product permits point-and-click binding of application components from the MTA repository to existing applications. Perceptive Informatics Inc. has launched a Web-based version of IMPACT, its clinical-trials management system (CTMS). Web-based IMPACT delivers additional functionality and provides online accessibility to critical trial-management data, enabling bio/pharmaceutical companies and clinical research organizations to better administer the complex process of conducting clinical trials. The Web-based version also offers an improved and intuitive user interface and navigation capability that enhances the overall usability of the system. IMPACT represents the core of a broader suite of clinical-trial management applications referred to as IMPACT Clinical Systems. The integrated application modules include Clinical Cost Tracking, Clinical Supplies Tracking, CRO Monitoring Portal, and Investigator, an investigator database solution. In addition, IMPACT has been integrated with Perceptive Voice, the company’s interactive voice response system, to provide automatic real-time data transfer. “Currently used by more than half of the top 20 pharmaceutical companies and with more than 14,000 users worldwide, IMPACT is a CTMS market leader,” says Mark A. Goldberg, M.D., president of Perceptive Informatics. “Enhanced functionality and online accessibility enable IMPACT Clinical Systems to surpass the traditional limits of clinical-trials management systems.” John Humphreys, Principal Clinical Consultant, (left) and Neil Hebenton, Senior Director, Development, (right) of Perceptive Informatics, say the integration and availability of the Web-based IMPACT system demonstrates the commitment of the company to be a driving force in providing solutions for enhanced clinical-trials management. ClinTrak, a Web-based, research management system from Medpace Inc., was specifically designed to support full-service clinical-trial management activities. ClinTrak allows Medpace associates, sponsors, and investigational sites to directly access near real-time study information and clinical data in a safe and secure environment. ClinTrak implements strong security measures at every critical access control point. All transmissions between users and the system are encrypted. This tool uses state-of-the-art technology and is validated to ensure compliance with 21 CFR Part 11 regulations. The new features of ClinTrak include generation of entry screens that closely resemble the paper case report form (CRF); CRF registration process that tracks CRFs through their entire life cycle; creation of flexible, real-time reports; an edit-check process that empowers data managers to construct and manage complex edit checks; an enhanced user-friendly interface; and multilingual capabilities within the IVRS system. ClinTrak, a Web-based, research management system from Medpace Inc., was specifically designed to support full-service clinical-trial management activities. ClinTrak allows Medpace associates, sponsors, and investigational sites to directly access near real-time study information and clinical data in a safe and secure environment. ClinTrak implements strong security measures at every critical access control point. All transmissions between users and the system are encrypted. This tool uses state-of-the-art technology and is validated to ensure compliance with 21 CFR Part 11 regulations. The new features of ClinTrak include generation of entry screens that closely resemble the paper case report form (CRF); CRF registration process that tracks CRFs through their entire life cycle; creation of flexible, real-time reports; an edit-check process that empowers data managers to construct and manage complex edit checks; an enhanced user-friendly interface; and multilingual capabilities within the IVRS system. Agilent Technologies Inc. has released the Agilent Cerity Networked Data System for pharmaceutical quality assurance/quality control (QA/QC). The system provides automated 3-D analysis, generic instrument control, and a spreadsheet-style custom calculator for the pharmaceutical QA/QC environment. This functionality, combined with Cerity’s advanced architecture, provides significant improvements in productivity, cost reduction, and compliance support for IT and laboratory managers. “The new Cerity enables pharmaceutical companies to evaluate and track the quality of raw and manufactured chemical compounds with the highest efficiency and productivity,” says Chris van Ingen, senior VP and general manager of Agilent’s Life Sciences and Chemical Analysis business. “We have coupled key analytical functionality with our compliance expertise and an industry-leading architecture to resolve many traditional problems for both the pharmaceutical IT and laboratory manager. For example, customers can use one computer with Cerity software to acquire and track data from up to 30 analytical instruments, a tremendous increase in efficiency from the usual 1:4 ratio.” The 3-D analysis feature enables an automated compound purity evaluation and confirmation of compound identity based on retention time, response, and wavelength. Automation of this process, performed daily in the analytical laboratory, reduces compound confirmation workflow time from hours to minutes. The custom calculator automatically performs all integral and mathematic calculations required in standard operating procedures, which is important because FDA 21 CFR Part 11 regulations require validation of every software package used, with error checking and cross-validation needed whenever manual data entry or data copying is used. This feature provides a calculation audit trail, eliminating the need for data copying and subsequent, extensive data validation. Cerity’s generic instrument control module enables laboratories to control non-Agilent chromatographic instrumentation with level-3 instrument control. For each instrument type, an instrument-specific driver or adapter is needed, which can be provided by Agilent or an Agilent alliance partner upon request. Camstar Systems Inc. has issued an integrated quality management and manufacturing execution system that enables manufacturers of combination drug and device products to capture the entire product history record. InSite Medical Device Edition Version 2.0 is the industry’s first solution to capture product quality and manufacturing information for combination products such as drug-eluted stents, intravenous drug-delivery systems, insulin pumps, and drug-releasing patches. “Many of our customers have manufacturing processes that include both a drug component and a device assembly component,” says Dave Cone, CEO of Camstar. “That requires both batch and discrete operations and makes tracking product information incredibly difficult to manage. Camstar’s solution captures both complex manufacturing methodologies in one system. A unified product history record allows our customers to achieve traceability and root cause capabilities, leading to significantly improved quality, compliance, and customer-service levels.” The out-of-the-box software solution enables compliance with FDA regulations 21 CFR Part 11 and 820. Cerity enables pharmaceutical companies to evaluate and track the quality of raw and manufactured chemical compounds. Acurian Inc., Horsham, Pa., is a provider of clinical-trial patient and investigator recruitment solutions for the life-sciences industry. For more information, visit acurian.com. AdvanTechnologies Inc., New York, provides state-of-the-art knowledge management enabling software products and associated decision support tools targeted to the pharmaceutical, biomedical, and healthcare industries. For more information visit advantechnologies.com. Agilent Technologies Inc., Palo Alto, Calif., is a global technology leader in communications, electronics, life sciences, and chemical analysis. For more information, visit agilent.com. Blue Diesel, Columbus, Ohio, an inChord Communications Inc. division, is an interactive communications company that blends strategic marketing, technology, and creative design to provide evidence-based interactive solutions. For more information, visit bluediesel.com. Camstar Systems Inc., Campbell, Calif., is a provider of enterprise manufacturing performance management systems for life-sciences, semiconductor, electronics, and other global industrial manufacturers. For more information, visit camstar.com. CareTools Inc., Seattle, provides technologically advanced point-of-care systems using Microsoft Pocket PC devices that enable the individual practitioner to automate CMS compliant chart notes, charge capture, as well as prescription writing. For more information, visit caretools.com. CDISC, Austin, Texas, is a nonprofit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission, and archiving of clinical-trials data and metadata for medical and biopharmaceutical product development. For more information, visit cdisc.org. DataLabs Inc., Irvine, Calif., is a developer of Internet-based applications for clinical development that enable the biopharmaceutical industry to bring medications to market faster and at a reasonable price. For more information, visit datalabs.com. Everypath Inc., Santa Clara, Calif., is a provider of mobile task automation software to global 1,000 companies, enabling enterprises to lower costs while increasing their visibility into field operations and increasing the productivity of mobile workforces. For more information, visit everypath.com. HCPro Inc., Marblehead, Mass., is a publisher and educator on regulatory and compliance issues that are faced by hospitals, home health organizations, nursing homes, physicians’ offices, and other healthcare facilities. HCPro publishes 34 monthly newsletters, 40 weekly e-zines, and more than 150 books about healthcare compliance and regulatory issues for the healthcare industry. For more information, visit hcpro.com. Ion Wave Technologies Inc., Springfield, Mo., is a software development company providing Web-based software applications for education, government, and the private sector. For more information, visit ionwave.net. Medpace Inc., Cincinnati, provides integrated services to pharmaceutical companies to bring promising new drugs to market, including clinical-development plan preparation, study management, regulatory document preparation, safety surveillance, clinical monitoring, data management, statistical analysis, medical writing, quality assurance auditing, and U.S. and international regulatory submissions. For more information, visit medpace.com. NoInk Communications, Indianapolis, provides integrated handheld and Web-based sales, marketing, and logistics applications for medical and pharmaceutical professionals. For more information, visit noink.com. Perceptive Informatics Inc., Waltham, Mass., a subsidiary of Parexel International Corp., develops and offers a portfolio of innovative technology-based products and services that facilitate clinical-drug development and are designed to decrease time to peak sales. For more information, visit perceptive.com. SciQuest Inc., Research Triangle Park, N.C., provides on-demand solutions that integrate organizations with their suppliers to enable comprehensive spend management for the life-sciences and higher education markets. For more information, visit sciquest.com. SupplyScape, Cambridge, Mass., is dedicated to helping pharmaceutical manufacturers, wholesalers, and pharmacies gain positive ROI on their technology investments to deliver safe drugs. For more information, visit supplyscape.com. TheraDoc Inc., Salt Lake City, is a medical informatics company specializing in the real-time decision support that improves the quality, safety, and efficiency of patient care in large and small healthcare organizations. For more information, visit theradoc.com. Thomson PDR, Montvale, N.J., is part of The Thomson Corp. and publisher of the PDR, the drug information standard for 57 years. For more information, visit thomson.com. Valeant Pharmaceuticals International, Costa Mesa, Calif., is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures, and markets a range of products. For more information, visit valeant.com. Wolters Kluwer Health Pharma Solutions, a unit of Wolters Kluwer Health, based in Parsippany, N.J., provides information and communications support for the pharmaceutical industry, from drug discovery and research to launch and marketing. For more information, visit wkhealth.com.

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