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New Electronic and Web-based Applications, Sites, and Technologies
Covance Enhances Web-based Central Lab Tool
Covance Inc. has enhanced the capabilities of its LabLink online access tool for central laboratory test data. LabLink now provides clients with access to information pertaining to the management of test specimens and the status of time-sensitive kits supplied to investigator sites. Additionally, users now have increased autonomy and flexibility to create and schedule reports on the status of their clinical-trial laboratory tests. LabLink is a secure, Web-based system that enables Covance Central Laboratory Services’ biopharmaceutical clients to monitor the progress of their clinical-trial laboratory tests through online review and downloadable reports, providing laboratory results, as well as investigator and patient demographic information. The addition of specimen-management data to LabLink enables sponsors to track the shipment of their study test specimens into any of Covance’s central laboratory locations worldwide. Sponsors can review the lab test results associated with individual specimens, as well as their subsequent storage at a Covance facility or transfer to a third-party referral laboratory. Also, LabLink now provides kit expiration information that allows sponsors to communicate with investigator sites to ensure timely use of kits, as well as proactive reorder and resupply of valid kits. Covance also has enhanced the system’s reporting capabilities. Users may now save and share report criteria, defined through LabLink’s ad-hoc query function, and autogenerate reports according to predefined schedules. Covance’s LabLink now provides clients with access to specimen-management data, kit-expiry information, and enhanced reporting capabilities, says John Raker, Director, Clinical Data Management, Covance Central Laboratory Services. MasterControl Releases Customer Complaints Solution Customer complaints provide important feedback in any kind of business, but they are especially critical in the life-sciences and general manufacturing industries, in which complaints may indicate serious safety issues. In both FDA and ISO environments, customer-complaint handling is considered an essential part of the quality system. With that in mind, MasterControl Inc. has released MasterControl Customer Complaints, a technology solution for automating, streamlining, and effectively managing the complaint-handling process to ensure regulatory compliance. Its key features include: a simple, three-step process for directing complaints to the appropriate manager; a secure, time-stamped audit trail that is FDA and ISO compliant; advanced analytics and reporting capabilities to increase management oversight and demonstrate appropriate controls to regulatory agencies; the FDA’s MedWatch 3500A form for mandatory reporting of adverse events; and seamless integration with MasterControl’s Corrective and Preventive Action (CAPA) solution to automatically escalate any serious quality problem. Customer complaints should be an integral component of the overall quality system. MasterControl enables customers to connect quality processes, such as the ability to automatically launch a MedWatch form or CAPA process directly from a severe customer complaint, says Brian Curran, Senior VP, Product Management and Strategic Marketing, MasterControl Inc. Knipper Launches Marketing Services Suite J. Knipper & Co. Inc. has launched Sample360°, a suite of tools that integrates a wide range of marketing services, which are designed to facilitate sampling programs and sample-compliance policies and procedures for pharmaceutical and biotech companies. “Sample360º’s combination of innovative and traditional solutions for the dynamic gamut of drug-sampling practices and processes can elevate pharmaceutical companies’ significant investment in sampling to new heights of performance,” says James J. Knipper, president and CEO. Sample360º features comprehensive, cost-efficient solutions for pharmaceutical companies that enable them to stay in compliance with the Prescription Drug Marketing Act (PDMA) and Drug Enforcement Administration (DEA) regulations. Sample360º provides solutions to issues such as sample distribution support, sample agent personnel, and direct-to-practitioner distribution of samples. Additionally, the suite of services includes alternative sampling options and sample-accountability systems. Sample360º is engineered to be flexible, with customized services to complement each client’s existing culture, policies, and procedures. Understanding that the primary function of sales representatives is to call on their targeted practitioners, Sample360º features extensive sample distribution platforms to support sales efficiency. Through an easy-to-use Web-based ordering system, Knipper can warehouse and ship products directly to sales reps in bulk quantities, based on cyclical schedules or orders placed in the system. For customers who require cost-effective assistance in reaching their targeted practitioners directly, sampling agents are available. These well-trained individuals are focused exclusively on providing samples only to physicians at lower cost than traditional sales representatives who both detail and sample practitioners. The direct-to-practitioner option focuses on providing optional methods of response to sample requests made by physicians. Knipper ships samples directly to licensed prescribers, a service ideal for vacant territories and for reaching physicians who are in a noncalled-on category. A host of sample request options include direct mail and a novel Web-based solution. The direct-mail option features BRCs that Knipper can design, print, and personalize in-house. Sample360° is engineered to be flexible, with customized services to complement the client’s individual culture, policies, and procedures that are already in place, says James J. Knipper, President and CEO of J. Knipper & Co. PureMedEd Launches Medical Education Website PureMedEd has launched its medical education Website at puremeded.com. The site features medical education, programming, and corporate information for professionals, industry partners, and consumers. The site also provides visitors with the opportunity to sign up for the PureMedEd monthly newsletter, which offers the latest information on the company, its programs, health news, and industrywide updates. The company plans on using the Website not only to provide agency information, but also to offer information on registration for ongoing programming, highlight health news, showcase the latest in medical-education ideas and opportunities, and feature healthcare-oriented streaming video. Our new Website enables us to interact with the public and the medical community to learn what they want and need so we can create state-of-the-art content in the most desirable format, says Ben Caref, Ph.D., President of PureMedEd. Maritz Travel Releases Incentive Travel Insight Solution Maritz Travel has launched Maritz Travel Insight, a new survey and analysis tool that increases the effectiveness of corporate incentive travel programs. Maritz Travel Insight works by polling employees to determine what activities and interests are most motivating to them. Results are then compiled into an easy-to-use decision-support tool that companies can use to build and test the motivational return of different travel experiences, based on a variety of trip options, activities, destination preferences, preferred month of travel, and other incentive travel reward factors. The solution produces a report showing the value of each travel experience in motivating employees, in total and by demographic segment or segments. According to each company’s specific employee data and the Maritz Travel Insight tool, Maritz is able to help clients understand the trade-offs associated with different combinations of program elements, such as the benefits of offering a number of destinations to choose from or specific numbers of days of the trip versus offering a choice in travel dates. This enables companies to construct the most effective mix of travel experiences to better motivate their employees. For example, a nationwide survey conducted using the Maritz Travel Insight tool found that 76% of respondents prefer smaller trips that offer choice in dates, destinations, and activities. The poll also found that 14.5% of employees who won trips failed to attend at least one earned trip because the trip was unappealing (16%) and the dates conflicted with their schedules (65%), among other reasons. This tool enables companies to compare the motivational impact of one travel experience versus another across different groups of people so they can identify the most effective mix of travel rewards to increase employee performance and ultimately improve a company’s return on incentive program spend, says Christine Duffy, President and CEO of Maritz Travel. Pri-Med Introduces E-CME on Disaster Relief In the wake of devastating hurricanes and the threat of a flu pandemic, Pri-Med has launched a Disaster Relief and Treatment Center on Pri-Med Online. The online curriculum offers primary-care practitioners expert perspectives, clinical review, and case studies focused on the health issues borne by natural disasters. “Primary-care practitioners are at the epicenter of catastrophes such as Hurricanes Katrina and Wilma,” says Alan Lotvin, M.D., president of Pri-Med. “They contend not only with the immediate impact of a public-health emergency but the lingering effects on victims’ health. The need for ongoing, focused, and readily accessible continuing medical education on these often-unfamiliar challenges is urgent.” Pri-Med Online offers accredited activities on topics such as: health effects of mold, dermatitis, West Nile virus, management of viral outbreaks, and post-traumatic stress disorder in children. The online curriculum offers primary-care practitioners expert perspectives, clinical review, and case studies focused on the health issues borne by natural disasters. IMS Health Unveils Global Portfolio of Promotion Management Solutions IMS Health Inc. has launched IMS Promo.360, a powerful portfolio of global offerings that equip pharmaceutical marketing teams with a comprehensive, consistent, and tailored approach to promotion management. The offerings combine the strength of IMS’s global information assets and business expertise to drive improved return on investment of promotional campaigns and enhance brand performance at the local, regional, and global levels. Enabling pharmaceutical decision makers to establish and share benchmarks and best practices, IMS Promo.360 brings together IMS’s information, analytics, and consulting capabilities to support brand-marketing decisions at all stages of product development — from prelaunch through maturity — for single or multiple brands. The robust solution features a combination of consulting and syndicated offerings, including: IMS Promo.Cast for forecasting brand performance based on specific investment assumptions; IMS Promo.Mix for determining the optimal mix of promotional efforts to drive brand performance; and IMS Promo.Return for quantifying the impact and return from specific promotional efforts. Additionally, the solution includes IMS Promo.Message for a comprehensive view of message efficacy and impact; IMS Promo.Equity for evaluating how companies are perceived by physicians and the role those perceptions play in promotion effectiveness and brand performance; IMS Promo.Detail for monitoring and benchmarking field-force implementation of a brand’s strategy; and IMS Promo.Track a syndicated offering that tracks the volume, type, and variety of promotional efforts in the market. These solutions can be purchased individually or as part of a customized, integrated IMS solution. Face-to-face detailing and sampling are no longer enough to drive market share, and physicians are no longer the single customer. IMS’s approach enables pharmaceutical brand managers to apply evidence-based analytics and leverage best practices across markets, which drives more efficient, effective use of promotional resources, says David Gascoigne, Practice Leader, Promotion Management, IMS Management Consulting. H.D. Smith Electronically Processes DEA- Compliant Orders H.D. Smith is successfully processing electronic 222 orders for controlled substances using iSoft Corp.’s e222 CSOS solution, in accordance with the U.S. Drug Enforcement Administration’s (DEA) controlled substance ordering system (CSOS). The electronic CSOS replaces costly paper-based systems by providing secure electronic transmission of controlled substance orders between manufacturers, distributors, and pharmacies. To facilitate this process, iSoft’s e222 CSOS application creates an electronic version of DEA Form 222 (e222), supporting digital signatures and providing a secure, reliable platform for transactions between buyers, suppliers, and the CSOS. The system also uses radio frequency identification (RFID) tags, which act as unique identifiers, or “license plates,” for each individual package. The ability to track inventory individually provides maximum control over products in the supply chain. H. D. Smith’s combination of RFID and CSOS technology generates efficiency, control, and accountability over controlled substance products, says Dale Smith, President and CEO of H.D. Smith. Isensix Launches Integrated Suite of Wireless Monitoring Solutions for Regulatory Compliance Isensix Inc. has launched an integrated suite of solutions for the pharmacy market; the wireless monitoring solutions help pharmaceutical marketers and manufacturers meet USP 797 and other regulatory compliance requirements, including MMA Part D. “The pharmacy market has been challenged to comply with a number of new regulatory requirements to ensure the safety of medications,” says Douglas W. Berg, president and CEO of Isensix. “In addition, complying with these regulations has become tougher as inspectors from various agencies, including the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), began to implement the new unannounced inspection process as of January 2006. Our new suite of products, focused exclusively for pharmacies, will contribute to our customers’ plans to meet these new challenges.” The ARMS system is designed to improve the safety of stored medications, vaccines, and pharmaceutical products through automation, resulting in confidence in medication management and patient safety. The system features a simple user interface that is accessible from any Web browser. The system is scalable to efficiently provide coverage of monitored units in large campus environments, as well as single facilities. Real-time alert capabilities through e-mail, pager, and mobile phone text, as well as escalation notification services, keep technicians and management informed of any out-of-range conditions. “Proper differential pressure and air flow during drug compounding has been a concern in the pharmacy market based on drug-sterility and employee-safety issues,” Mr. Berg says. “With the Isensix system, all processes are automatically monitored, and an alarm is triggered to notify a staff member immediately if any issue arises.” The ARMS system is designed to improve the safety of stored medications, vaccines, and pharmaceutical products through automation, resulting in confidence in medication management and patient safety. Online Contract Manager Module Available from SciQuest SciQuest Inc. has released Contract Manager, the latest addition to its e-suite of spend-management and procurement-automation tools. The Contract Manager module strengthens an organization’s e-procurement strategy by automatically integrating supplier contracts with the purchasing experience. A centralized repository makes it easy to store, find, and view contracts. Through tight integration with SciQuest’s e-procurement tools, the solution provides seamless tracking, reporting, and analysis capabilities. Contract Manager provides the following features and benefits: contract visibility, which enables end users to control contract-management costs, improve contract-compliance rates, and increase contract awareness; contract tracking, which enables organizations to track deliverables and alert administrators when specific criteria have been met; and contract analysis, which allows organizations to identify and summarize contract commitments, spend data, rebates, or additional savings opportunities. Contract Manager is a response to our customers’ needs to manage their contracts and meet regulatory reporting and compliance requirements, says Jamie Duke, Chief Operating Officer of SciQuest Inc. Tagsys, Systech, and SupplyScape Release Integrated Solution to Fight Drug Counterfeiting Tagsys, Systech International, and SupplyScape Corp. have released a complete, integrated solution that allows pharmaceutical manufacturers to serialize, package, and distribute products. The jointly developed solution enables supply-chain partners to authenticate drugs throughout the supply chain and to create significant barriers to counterfeiting and diversion. Working seamlessly with most manufacturers’ existing infrastructure, the system offers innovative approaches to address three critical areas of system integration and deployment: radio frequency identification (RFID) tagging for authentication at the item-level; packaging line device management and data capture; and authentication services and e-pedigree compliance and management. The solution addresses the Pharmaceutical Research and Manufacturers of America’s recommended approaches for securing the U.S. drug supply against counterfeiting threats. Additionally, the solution provides compliance with pedigree requirements in Florida, California, and other states. “Drug counterfeiting has become one of the top concerns among drug makers, and many believe that the fight starts on the manufacturing floor,” says Shabbir Dahod, president of SupplyScape. “By offering a single solution that encompasses the technology and domain expertise critical to success, this effort will eliminate the technology hurdles to deployment.” Last year, counterfeit drug investigations nearly tripled, garnering extraordinary attention from the FDA and officials at state and federal levels. This integrated solution enables manufacturers to not only comply with upcoming regulatory and customer needs, but it also paves the way for future strategic value. By offering a single solution to address counterfeiting that encompasses the technology and domain expertise critical to success, our effort will eliminate the technology hurdles to deployment, says Shabbir Dahod, President of SupplyScape. Follow up Covance Inc., Princeton, N.J., is a comprehensive drug-development services company. For more information, visit covance.com. H. D. Smith, Springfield, Ill., is a full-service wholesale distributor that serves retail, hospital, and institutional pharmacies. For more information, visit hdsmith.com. IMS Health Inc., Fairfield, Conn., provides information solutions to the pharmaceutical and healthcare industries. For more information, visit imshealth.com. Isensix Inc., San Diego, provides Web-based, wireless monitoring systems for healthcare and life-sciences facilities. For more information, visit isensix.com. iSoft Corp., Addison, Texas, provides secure file transfer and B2B gateway solutions. For more information, visit isoft.com. J. Knipper & Co. Inc., Lakewood N.J., is a fully integrated pharmaceutical marketing services company. For more information, visit knipper.com. Maritz Travel, St. Louis, a unit of Maritz Inc., provides meeting, event, and incentive-travel management. For more information, visit maritztravel.com. MasterControl Inc., Salt Lake City, provides electronic quality-management systems, including comprehensive product training, technical support, and validation services. For more information, visit mastercontrol.com. Pri-Med, Boston, a division of M|C Communications, is a continuing medical education provider for primary-care practitioners, psychiatrists, pharmacists, and cardiologists in the United States. For more information, visit pri-med.com. PureMedEd, New York, is a full-service medical education agency. For more information, visit puremeded.com. SciQuest Inc., Cary, N.C., provides supplier management and procurement automation solutions that help customers gain greater visibility into and control over their spend. For more information, visit sciquest.com. SupplyScape Corp., Woburn, Mass., provides electronic pedigree software and expertise to safeguard and secure the pharmaceutical supply chain. For more information, visit supplyscape.com. Systech International, Cranbury, N.J., provides packaging performance management solutions for manufacturing operations. For more information, visit systech-tips.com. Tagsys, La-Penne-sur-Huveaune, France, provides radio frequency identification systems and tags for end-to-end item-level tracking that automate labor-intensive processes, authenticate and safeguardsgoods, and enable real-time inventory and asset visibility. For more information, visit tagsysrfid.com.