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

Featured Briefs: CenterWatch Service Matches Sponsors, Investigative Sites PPD, Microsoft Collaborate to Improve REMS ­Management Cegedim Dendrite Streamlines Tracking, ­Reporting Capabilities QPharma Assists with Marketing Spend Tracking HCD Social Monitoring Service Captures Brand ­Sentiment for Pharma Marketers Wilson Learning Expands Virtual Learning ­Portfolio Virtual Pharma Rep Unveils E-Detailing in South Africa Simulations Plus Releases Drug Discovery Design Software Sparta Unveils Quality Management Solution for Small Businesses ImpactRx Pairs iPhone App with Data ­Collection, ­Analytics Oracle Unveils Pedigree and Serialization Management ­Solution MedThink Virtual Tool Optimizes External Expert Engagement Sidebar: E-upgrades and enhancements Follow up CAPGEMINI U.S. LLC provides consulting, technology, and outsourcing services. For more information, visit us.capgemini.com. CEGEDIM DENDRITE provides compliance technology solutions and services to the pharmaceutical industry. For more information, visit cegedimdendrite.com. CENTERWATCH is a source of clinical trials information for both professionals and patients. For more information, visit centerwatch.com. HCD RESEARCH is a marketing and communications research company. For more information, visit hcdi.net. MICROSOFT CORP. is a global provider of software, services, and solutions that help people and businesses realize their full potential. For more information, visit microsoft.com. PPD INC. is a global contract research organization. For more information, visit ppdi.com. QPHARMA INC. delivers validation, engineering, PDMA compliance, and fulfillment solutions to FDA-regulated industries. For more information, visit qpharmacorp.com. WILSON LEARNING WORLDWIDE is a global leader in human performance improvement solutions. For more information, visit wilsonlearning-americas.com. CenterWatch’s recently introduced grant notification service is designed to assist biopharmaceutical companies and contract research organizations (CROs) in identifying and engaging investigative sites worldwide to conduct Phase I through IV clinical trials. Clinical research sponsors have become increasingly interested in recruiting skilled and active investigators from a larger and more diverse number of global regions. But a growing number of investigative sites are exiting the clinical research enterprise because they find it increasingly difficult to secure study grants. CenterWatch’s grant notification service matches clinical research sponsors with currently active, experienced investigative sites to provide an effective study grant generation tool for research professionals. The free service is largely automated through the CenterWatch website at centerwatch.com/trialwatch_signup. “We’re very pleased to be offering a new Web-based service to the global investigative site community,” says Joan Chambers, CenterWatch’s chief operating officer. “Our company has a long history of offering sites the opportunity to identify and secure study grants through our publications.” We’re excited to be providing ­sponsors and CROs with a quick and efficient way to identify and ultimately to contact viable ­investigative sites ­worldwide, says Joan Chambers. PPD and Microsoft are jointly implementing a technology-based solution designed to improve efficiency in managing FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs required for certain marketed drugs to ensure the benefits of a product offered to consumers outweigh the risks. The solution provides biopharmaceutical companies with a long-term system for managing operational components of REMS programs while tracking large amounts of information collected from multiple sources, including the patient, healthcare provider, and pharmacy. It integrates PPD’s strategic, scientific, operational, and regulatory capabilities in designing and implementing comprehensive REMS and risk management programs with Microsoft’s global software development expertise. “We are committed to combining operational and scientific excellence with leading REMS-specific technologies for this rapidly evolving sector of our industry and are pleased to collaborate with Microsoft in this effort,” notes Mike Wilkinson, executive VP and chief information officer for PPD. The technology is based on Microsoft Amalga Unified Intelligence System (UIS), a data aggregation platform that gives healthcare professionals access to the information they need, when they need it; and Microsoft HealthVault, a personal health application platform that lets consumers gather, store, and share health information online. “We’re excited to collaborate with PPD to deliver a new REMS solution for the biotechnology and pharmaceutical industry,” says Steve Shihadeh, general manager, Microsoft Health Solutions Group. Efficient, effective REMS ­programs require real-time access to information by ­multiple internal and external stakeholders, says PPD’s Mike Wilkinson. We are able to connect all of the stakeholders involved in REMS ­programs and make it much easier for them to get the right information at the right time, says Microsoft’s Steve Shihadeh. Today’s life-sciences ­companies need a solution that can automate the management of the massive amount of data required by the growing array of federal and state disclosure laws, says Bill Buzzeo. Cegedim Dendrite has unveiled the latest version of its State Guardian aggregate spend reporting tool under a new name, AggregateSpend360. The enhanced AggregateSpend360 enables life-sciences manufacturers to comply with increasingly complex federal and state aggregate spend reporting requirements. In particular, the updated solution includes new features that are specific to Massachusetts reporting requirements and the newly passed federal legislation known as the Physician Payments Sunshine Act. AggregateSpend360 includes data integration and automatic reporting and integrates with additional Cegedim Dendrite resources such as OneKey, a life-sciences-focused customer master data management solution. AggregateSpend360 also integrates with any third-party customer relationship management offering, including Cegedim Dendrite’s Mobile Intelligence. “We understand the business and reporting needs of our customers are not one-size-fits-all and provide flexibility by offering AggregateSpend360 as a software-as-a-service (SaaS) solution hosted by Cegedim Dendrite, or as a licensed model managed by the customer or Cegedim Dendrite,” says Bill Buzzeo, Cegedim Dendrite’s VP and general manager, compliance solutions and OneKey. Cegedim Dendrite also plans to launch AggregateSpend360 in Europe later in 2010, with features that address the needs of life-sciences companies doing business in Europe regarding transparency and spending limit requirements. In other moves, Cegedim Dendrite has integrated SK&A data into its OneKey offering following Cegedim Dendrite’s acquisition earlier this year of the healthcare information solutions and research provider. SK&A researches and maintains contact and profiling information for more than 2 million healthcare practitioners, including 800,000-plus prescribers. In addition, Cegedim Dendrite and Capgemini U.S. have formed an alliance to jointly offer software solutions, consulting, and technology services around aggregate spend and customer master data to life-sciences companies. Through the alliance, Capgemini provides broad-based consulting and implementation services associated with Cegedim Dendrite’s AggregateSpend360 and Nucleus 360 solutions to pharmaceutical, biotech, and medical-device companies. QPharma’s aggregate spend solution, qSpend, assists pharmaceutical, biotechnology, and medical-device companies in complying with the wide range of state and federal laws, regulations, and industry guidelines for tracking, evaluating, and reporting sales and marketing expenditures. The Web-based solution provides access anytime, anywhere to several means of capturing expense data, including manual data entry, file uploads, and third-party expense management system interfaces. qSpend is fully configurable, with customer-specific administrative preferences, thresholds, and alerts and is available as software on demand or as a fully outsourced service. “qSpend was developed to ensure compliance with the regulatory requirements while creating a flexible, sustainable model moving into the future,” observes Alexis Stroud, manager of regulatory compliance. “With constant change in the industry, it was imperative that we expand our regulatory compliance service offerings to assist life-sciences companies in complying with the myriad of aggregate spend and reporting requirements,” adds Chief Operating Officer Ray Roggero. With qSpend and our staff of ­regulatory ­specialists, ­QPharma provides a cost-efficient total aggregate spend solution, says Ray Roggero. Companies face many challenges in the ­implementation of their aggregate spend solutions in ­this changing landscape, says Alexis Stroud. HCD Research’s NetClassRX syndicated service uses social media to help pharmaceutical marketers qualitatively understand consumers’ and physicians’ sentiments and emotions associated with their particular brand, as well as competitors’ brands. NetClassRX helps medical marketers sift through the high volume of digital conversations about their brands and competitor brands by using proprietary algorithms to extract data from websites, forums, blogs, and social networks. “It also allows them to detect rumors and determine the impact of new product claims and other news related to their brand within 24 hours,” explains Glenn Kessler, president and CEO of HCD Research. NetClassRX is powered by automated data collection and evaluation tools that employ a series of complex algorithms to independently determine the tenor of consumer sentiment regarding classes and brands of products. The service allows marketers to view an analysis of aggregate data, which quantifies the ratio of positive to negative comments for each product in a class of drugs. In addition, the service categorizes positive and negative comments so that marketers can determine how consumers view a brand and a class of drugs on important product attributes. The service allows brand managers to view their brands’ health online and compare with the health of competitors’ brands on a daily basis using a ­summary ­dashboard, says Glenn Kessler. Wilson Learning Worldwide has introduced six new virtual learning programs designed to provide anywhere access to active, engaging training experiences that meet an organization’s specific learning needs. The new programs include courses on building relationships, sales and prospecting, coaching, consulting, and virtual team building. “As technology has evolved, today’s virtual classroom platforms enable true learning experiences that are fast-paced, highly interactive, and application-oriented,” says Ed Emde, president of Wilson Learning. “Our goal is to drive performance by transferring learning in a way that meets an organization’s specific needs.” “Virtual learning is more than retrofitting a face-to-face classroom program to be delivered over the Web,” adds Tom Roth, president of the global solutions group for Wilson Learning. With careful attention to best practices, virtual learning has great potential for reaching learners wherever they are, says Tom Roth. Contemporary virtual learning engages participants in the active learning of new skills, says Ed Emde. Virtual Pharma Rep has announced the launch of South Africa’s first-ever e-detailing campaign, in partnership with an unnamed major South African pharmaceutical company. Virtual Pharma Rep brings a new virtual sales approach to the market that revolutionizes expensive pharmaceutical sales models, supplements existing sales forces, and reduces marketing and promotional budgets significantly. The company leverages technology to deliver powerful multimedia messages to doctors that educate and provide important product and service information directly from the pharmaceutical company, much like a field sales rep. This new sales approach is designed to provide consistent, controlled, and fully customized messages to multiple doctors simultaneously through an online communication channel, along with various ways for doctors to communicate with companies in return. Messages can be accessed by doctors at their convenience, when their schedule allows, thereby saving precious time in their schedules. “New marketing strategies are necessary to stay competitive in any industry, and this is especially true now within South Africa, as marketing trends shift because of new technological advances,” says Jim Rediehs, CEO of Virtual Pharma Rep. “We plan to demonstrate that e-detailing, in conjunction with current marketing and sales strategies, is an effective way to penetrate target audiences, even those in hard-to-reach white spaces.” For more information, visit virtualpharmarep.com. The recently launched MedChem Studio drug discovery software from Simulations Plus combines the data-mining function of Simulations Plus’s former ClassPharmer tool and integrates it with the company’s ADMET Predictor molecule-design capabilities. When combined with ADMET Predictor, MedChem Studio helps chemists design new molecules with a multidimensional view of the many properties that are required for a molecule to become a drug. “With MedChem Studio and ADMET Predictor, chemists can ‘see’ the effects of modifying molecular structures not only on activity, but on many additional key properties, enabling them to modify a structure to simultaneously optimize activity and other properties,” observes Chairman and CEO Walt Woltosz. “MedChem Studio is the result of a continuous evolution of our ClassPharmer software, with new capabilities added that have taken it beyond the pure data-mining tool that ClassPharmer was and transformed it into a platform that combines data mining and, when integrated with ADMET Predictor, powerful new molecule design capabilities,” adds David Miller, Ph.D., team leader for discovery cheminformatics. For more information, visit simulations-plus.com. Medicinal chemists have a very challenging job, so ­challenging that many spend their entire careers without ever creating a successful drug, says Walt Woltosz. MedChem Studio is the result of a continuous evolution of our ClassPharmer software, with new capabilities added, says Dr. David Miller. ImpactRx has made available an iPhone application that uses the company’s longitudinal physician network to provide pharmaceutical companies with timely and actionable insight into drug therapy promotion and treatment activity. Highly mobile clinicians have limited time to complete Web-based diaries and market research surveys based upon memory recall after the fact. ImpactRx’s iPhone app improves electronic data capture (EDC) accuracy by giving physicians the freedom to record and document as they go, making it more a part of their natural work flow. The mobile app is also available for Apple’s iPad platform. In addition to longitudinal tracking, this mobile market research tool allows ImpactRx clients to ask “POP” research questions when specific conditions are met providing deeper insight in real time. “We are thrilled that our existing physician-behavior expertise will benefit from iPhone’s powerful functionality,” says ImpactRx President and CEO Richard Altus. For more information, visit impactrx.com. Exciting ­developments align ImpactRx with ­cutting-edge ­technology, enabling us to ­continue to provide our clients with ­visibility into the ­pharmaceutical marketplace, says Richard Altus. Sparta Systems has made available TrackWise SelectStart, a packaged solution designed for small- and medium-sized businesses seeking to deploy a quality and compliance management system. SelectStart offers a total solution for quality systems workflows based on industry best practices; a comprehensive validation package including full performance qualification; and a documented, industry-tested deployment plan to allow for a rapid, cost-effective implementation. It also provides the scalability to meet enterprise growth, with the ability to add and expand processes and give companies the flexibility to evolve as their organizational quality requirements become more complex. “Emerging small businesses face the same regulatory compliance challenges as large companies, without the same financial resources or staff,” says Mike Jovanis, Sparta’s VP, product management. “TrackWise SelectStart addresses the needs of these businesses by giving them an easily deployable and total solution to support a culture of quality.” For more information, visit sparta-systems.com. The Oracle Pedigree and Serialization Manager is an integrated mass-serialization and pedigree application designed specifically to improve supply-chain integrity in the pharmaceutical industry. The solution helps pharmaceutical manufacturers facilitate compliance with emerging electronic pedigree (e-pedigree) initiatives and regulatory requirements, reducing business and reputational risk associated with the rising incidence of drug counterfeiting and product diversion. It generates, stores, transmits, and authenticates serial and e-pedigree data as pharmaceutical products move across the supply chain. In addition, integrated analytics within the solution provide pharmaceutical manufacturers with expanded insight into possible threats. Built on an open standards-based service-oriented architecture (SOA) and Oracle Fusion Middleware applications, Oracle Pedigree and Serialization Manager supports Web services and integrates seamlessly with existing Oracle and third-party systems for manufacturing, packaging, and shipping and receiving. “Ensuring supply chain integrity is not only about compliance and protecting your brand, it’s also about protecting your bottom line,” says Jon Chorley, VP of SCM product strategy. “By definitively identifying your products in the supply chain and providing a broad set of analytic insights on that data, Oracle Pedigree and Serialization Manager delivers both. The result is a safe and secure pharmaceutical supply chain, combined with a strong ROI.” For more information, visit oracle.com. Digital collaboration tools enable companies to be seen by their opinion leaders as incorporating the latest ­technology, says Jon Hudson. MedThink Communications’ customizable Web application, MedThink Connect, gives healthcare companies a vehicle to efficiently seek guidance, maintain interaction, and build a community atmosphere with external experts. “In today’s digital age where rapid information exchange is a necessity, additional opportunities exist to guide decision-making by improving communication and collaboration between and among expert opinion leaders and a company,” notes Steve Palmisano, VP, medical communications. MedThink Connect has been developed in response to industry changes, new guidelines, evolving client needs, and recent research conducted with external experts and clients indicating strong interest in supplementing face-to-face interaction with a digital engagement platform. The platform creates a secure, virtual community in which companies and external experts can broaden interactions, seek guidance, facilitate discussion, and provide a centralized resource for information and materials. “Physician experts want to engage online, and as our research highlights, they do not believe they have easy access to all the information needed to provide their best counsel,” says Jon Hudson, VP, digital and media services. For more information, visit medthink.com. Providing cost-efficient ­business solutions that use ­digital technology can help an organization further ­supplement face-to-face ­interaction with experts in the field, says Steve Palmisano. BARNETT INTERNATIONAL has made available a fully searchable electronic version of its 2010/2011 Parexel Bio/Pharmaceutical R&D Statistical Sourcebook. The electronic version is available in single and multiuser versions and contains the same statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry as the print Sourcebook. For more information, visit barnettinternational.com. PHARMAVIGILANT has unveiled an enhanced version of its I-Vault electronic trial master file (TMF) system that offers easier access to data that sponsors need to make quick, effective decisions related to their clinical trial. I-Vault 2.5 includes key features such as enhanced e-mail notifications and document tracking capabilities, improved reporting functionality, and signed and approval status. For more information, visit pharmavigilant.com. SIMULATIONS PLUS has released a major upgrade of its ADMET Predictor software for predicting properties of molecules with only their structures as inputs. ADMET Predictor 5.0 incorporates a series of new predictive models that broaden the scope of the offering, as well as completely retrained existing models with further improved accuracy and new output options for better visualization of results. For more information, visit simulations-plus.com.

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