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E-upgrades and enhancements
Prolifiq’s recent software release, Prolifiq for Life Sciences, is designed to help pharma, biotech, and medical-device companies comply with an increasingly complex web of regulations governing electronic sales communications. Constantly evolving guidelines, regulations, and laws from multiple governmental bodies make it increasingly difficult for life-sciences companies to provide scientific, promotional, and educational materials to healthcare practitioners. Prolifiq’s new software can be used to organize, send, and track approved digital content to these audiences. With Prolifiq for Life Sciences, mobile sales representatives can customize and disseminate approved sales materials to prospective customers, while an embedded rules engine monitors the communication and helps users engage in policies and standard operating procedures that ensure compliance with applicable laws, regulations, codes of ethics, and accepted industry standards related to promotional efforts. “We take the headache out of marketing, sales, and compliance, enabling life-sciences companies to focus on what they do best: developing the best products and technologies to improve life, says Jeff Gaus, CEO of Prolifiq. Phase Forward has released its DefineValidator tool, Release 1.0, as a free download for CDISC adopters in an effort to help sponsors identify and correct define.xml file format errors before submitting clinical data to the FDA, which should streamline the submission process for both parties. The FDA uses the define.xml file format to understand the contents of CDISC SDTM submissions; thus, the format is necessary to load clinical study data into the FDA’s Janus data warehouse. Problems with the file format can delay loading of submission data and make it difficult for reviewers to understand SDTM data submissions. Unfortunately, many of these files received to date by the FDA have been problematic, partly because of the lack of a widely available validation tool. “We’re very pleased that Phase Forward has contributed this important tool to the standards community,” says David Iberson-Hurst, VP of technical services for CDISC. “The free release of this tool underscores Phase Forward’s longstanding commitment to industry standards,” says Steve Rosenberg, senior VP of products and services for Phase Forward. In other news, Phase Forward has made available the latest version of its Interactive Response Technology (IRT) solution, which gives managers direct control over clinical supply management and helps to provide assurance of supply availability at randomization. Enhancements to Phase Forward IRT 5.0 include an integrated drug forecasting module for advanced global clinical trial supply management and an enhanced user interface to streamline navigation and consolidate workflow. Deloitte Recap has launched the first two complementary modules in the Recap IQ Series by Deloitte, a new subscription service designed around specific biopharmaceutical research needs. The Recap IQ Series provides analytical tools built on databases tailored toward business development, corporate strategy, financial, legal, tax, and R&D professionals. “The powerful combination of IQ Series products enables users to observe leading practices in drafting an alliance and evaluating different deal structures,” says Mark Edwards, president of Deloitte Recap. “Subscribers can compare deals objectively to identify critical deal terms, including market rates for royalties, transfer prices, and profit splits.” The first two modules are Deal Builder and Valuation Analyzer, which can either be purchased separately or bundled together. The Recap IQ Deal Builder module is a comprehensive, fully searchable database of 30,000 biopharma and related alliances covering the past three decades, including 24,000 U.S. Securities and Exchange Commission-filed contracts. The Valuation Analyzer provides access to the Recap Effective Royalty Rate (EFR) Grapher, a tool used to perform real-time searches of more than 1,500 unredacted biopharmaceutical alliances. New Momentum is now offering MAP Monitor, a cost-effective solution that stops the brand, margin, and channel loyalty losses resulting from rogue distributors selling products at lower-than-minimum advertised price (MAP) by making it easy for manufacturers to identify the violations and halt the illegal activity. New Momentum CEO Stu Clifton observes that channel pricing violations are costing manufacturers billions annually. “In the past, it’s been difficult and costly for companies to track Internet channel sales to ensure that their brand and margins are not being compromised by distributors selling at less than MAP,” Mr. Clifton says. “Now, our advanced search capability makes it easy to identify pricing violations.” In addition to providing MAP violations reports at a frequency determined by the customer — daily, weekly, or monthly — the MAP Monitor service includes assistance from New Momentum brand protection/gray market experts with all aspects of the enforcement process. We are marrying compliance and sales, helping companies integrate compliance directly into their marketing, sales, and promotional efforts while creating new efficiencies, says Jeff Gaus. As a founding sponsor of CDISC, we want to help ensure the widespread adoption of standards, making the submission process work more smoothly for everyone, says Steve Rosenberg of Phase Forward. Tools like this will help increase the adoption of CDISC standards among sponsors and help the FDA to continue to realize the many benefits of working with CDISC data standards, says David Iberson-Hurst of CDISC. Channel pricing violations are costing manufacturers billions annually, says Stu Clifton. BravoSolution and SciQuest have combined their solutions and industry expertise in a source-to-settle offering for healthcare providers and life-sciences organizations. The partnership is intended to reduce costs and improve the efficiency of the supply chain for organizations committed to managing cost while optimizing their procurement and supply chain operations. Pharmaceutical companies know that how they source and manage supplier performance and use supplier contracts to their advantage unlocks millions of dollars in savings and helps them with compliance. The joint offering features a range of solutions, including: • Spend Snapshots: spend analysis profiles with procurement ROI benchmarking; • Integrated Strategic Sourcing and Procurement: with best-of-breed solution modules from BravoSolution and SciQuest; and • Professional Services: including implementation, training, and quarterly “Wellness Checks” to track and measure performance and success in meeting goals. “As our clients look for innovative approaches to reduce their costs while maintaining the highest supply chain standards, SciQuest and BravoSolution are resources that organizations can turn to for proven best practices and best-of-breed solutions,” says Stephen Wiehe, president and CEO of SciQuest. “Our combined experience and dedication to our clients’ success make us the clear choice for healthcare and life sciences source-to-settle solutions,” Mr. Wiehe says. This software-as-a-service (SaaS) offering delivers a low footprint option for IT-strapped organizations with the ROI being immediate and robust. These solutions enable clients to: • Reduce cost of care and negotiate and leverage strategic contracts for commodity goods and services; • Track and manage contracts and ensure compliance; • Improve the quality of supplier content; • Ensure accurate price files; • And drive on-contract spend. “This partnership allows us to continue to expand our offering to visionary organizations who seek opportunities to control costs through more efficient supply chains,” adds Marc Bergeron, general manager of BravoSolution US. StayinFront EdgeRx is a new on-demand customer relationship management (CRM) and analytics solution developed by StayinFront specifically for pharmaceutical and biotech companies, providing an offering with rich functionality, fast deployment, agility in the field, and analytics. StayinFront EdgeRx helps field sales teams more effectively manage their territories and enables sales managers to measure, respond, and coach their teams for improved productivity and overall results. The product also includes comprehensive hosting services, automatic upgrades, Web-based training, and the option to add support services such as help desk and hardware asset management. “StayinFront EdgeRx offers the ability to deploy a new CRM system rapidly, reduce costs, and still provide sales and marketing teams with the tools they need to drive market share,” notes Ken Arbadji, VP of sales for StayinFront U.S. IMS Health’s recently launched IMS Midas Global Biologics offering enables clients to assess opportunities in the fast-growing, $120 billion worldwide biologics market. Midas Global Biologics was developed in consultation with leading industry associations, including The Pharmaceutical Business Intelligence and Research Group (PBIRG). It establishes a market definition for biologics and provides an understanding of biologics at both the molecule and product level for deeper insights into market size, performance, and changing biologics usage in more than 70 countries. “For companies looking to expand in this market, IMS Midas Global Biologics can help them quickly identify biologic molecules, determine their importance in treatment, and understand the forces underlying performance, which are all key to ensuring effective portfolio strategies and maximizing return on investment,” says Jim Mahon, general manager, product and portfolio management, IMS. Midas Global Biologics is the latest addition to IMS’ New Models, New Metrics program, which provides market measurement services to help clients better navigate today’s healthcare environment. Symyx Technologies now offers a hosted informatics software solution to researchers working in academia and the pharmaceutical, biotechnology, and chemical industries that combines Symyx software with data-archiving capabilities in a secure data hosting and communications facility. Symyx’s hosted informatics environment enables more research and development organizations to benefit from scientific software by reducing the requirements for IT infrastructure and resources, lowering total cost of ownership, and accelerating electronic lab notebook (ELN) deployment. Initially, Symyx Notebook is being made available as a hosted ELN service, enabling biologists and medicinal and synthetic chemists to manage, explore, share, and reuse experimental information and intellectual property (IP). Using a hosted ELN service, R&D organizations can deploy and leverage the electronic notebook quickly and efficiently without added IT infrastructure and resources while collaborating more effectively with partners in today’s information-driven R&D environment. “In a time of tight budgets and increased outsourcing, we’re working closely with customers to build a secure, hosted informatics hub that satisfies IP capture requirements, improves collaboration, and reduces costs,” says Trevor Heritage, Ph.D., president of Symyx’s software business unit. “Symyx’s hosted ELN service is an important milestone in the evolution of an informatics environment that enables more scientists across the globe to benefit from research software previously not supportable within their organizations,” he says. We have streamlined implementation and speed-to-deployment without compromising the critical biopharma functionality our customers rely on, says Ken Arbadji.A flow of innovative products and expanding indications are driving high-value patient treatment options and fueling strong growth for biologics around the globe, says Jim Mahon. Quintiles is sponsoring a new Web site, clinicalresearch.com, that enables potential clinical research participants to identify clinical trials to participate in, regardless of geography or drug company sponsor. Lack of participation in trials is one of the major factors in lengthening the development of new drugs. Quintiles executives believe that if more people understood the crucial role of clinical research in identifying cures and therapies, then more people would be willing to participate in the research. The new site helps to generate that understanding by presenting easy-to-use, comprehensive information to potential participants. “Research shows that 75% of the general public state they have little or no knowledge of clinical research and the participation process,” says Chris Cabell, head of global access to patients. “We want to change that statistic. If patients and their families are more aware of the opportunities that clinical research can provide, they will be better able to make informed decisions about participating in research and help drive the development of new and better medicines.” Patients who visit the clinicalresearch.com Website can identify ongoing or future clinical trials appropriate for their disease or condition and narrow them down to those that are geographically convenient. The Website also provides comprehensive supporting information about clinical research, including videos describing real-life patient experiences and news from recent studies, and allows patients to connect with other individuals about their insights into clinical research. DECISIONVIEW has made available a software-as-a-service (SaaS) version of its flagship StudyOptimizer clinical trial enrollment solution. Under the new model, DecisionView provides hosting, implementation, and support of StudyOptimizer on a pay-as-you-go basis. For more information, visit decisionview.com. ICON PLC. has released a new version of NONMEM, the company’s non-linear, mixed effects modeling tool for population pharmacokinetic/pharmacodynamic (PK/PD) data analysis. The new suite provides a more comprehensive range of classical estimation methods. For more information, visit iconplc.com. NEXTRIALS has made a significant upgrade to its flagship Prism electronic data capture and clinical trial management platform. Prism now offers expanded functionality and interoperability with electronic health records from multiple vendors. For more information, visit nextrials.com. OMNICOMM SYSTEMS has added a SDTM solution to its flagship TrialMaster EDC product that allows for mapping and exporting of data directly into the CDISC SDTM format preferred by the FDA. For more information, visit omnicomm.com. ORACLE’s Application Integration Architecture Release 2.5 includes a new Process Integration Packs for health sciences. Oracle AIA PIP for Health Sciences integrates Oracle Remote Data Capture with Oracle’s Siebel Clinical Trial Management System. For more information, visit oracle.com. Sage Templates Version 1.1.3, the new release of SAGE SUBMISSIONS’ templates for eCTD submissions, includes new content templates for European Medicines Agency and U.S. FDA submissions. For more information, visit sagesubmissions.com. SIMULATIONS PLUS has released ClassPharmer 4.7, the latest version of its software used by pharmaceutical research scientists for analysis of chemical libraries and design of new molecular structures. The latest version adds a number of enhancements to ClassPharmer’s data mining and molecule design capabilities. For more information, visit simulations-plus.com. SKYSCAPE is now providing its mobile medical information to smartphones using Google’s Android operating system, including three free resources for the Android Reader. For more information, visit skyscape.com. E-upgrades and enhancements New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Prolifiq Software Incorporates Good Promotional Practices for Sales Phase Forward Unveils Free Tool to Streamline FDA Submissions Deloitte Recap Offers Business Intelligence Tools New Momentum Offers Channel Pricing Solution BravoSolution and SciQuest Announce Source-to-Settle Life-Sciences Partnership StayinFront Delivers On-Demand CRM Solution IMS Offers Tool for Assessing Biologics Market Symyx’s Hosted Informatics Solution Speeds ELN Deployment Quintiles Launches Web Site To Drive Clinical Research Participation Sidebar: E-upgrades and Enhancements Follow Up BRAVOSOLUTION provides supply management software and services to companies worldwide. For more information, visit bravosolution.com. DELOITTE RECAP LLC, part of Deloitte LLP, offers intelligence subscription tools and consulting services tailored toward business development, corporate strategy, financial, legal, academic, and R&D professionals. For more information, visit recap.com. IMS HEALTH is a provider of market intelligence to the pharmaceutical and healthcare industries. For more information, visit imshealth.com. NEW MOMENTUM is a provider of SaaS-based anti-counterfeiting and channel integrity solutions. For more information, visit newmo.com. PHASE FORWARD is a provider of data management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. PROLIFIQ helps sales professionals use digital content in their communications with customers and prospects. For more information, visit prolifiq.net. QUINTILES is an integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. For more information, visit quintiles.com. SCIQUEST INC. provides global procurement automation and supplier enablement solutions. For more information, visit sciquest.com. STAYINFRONT INC. is a global provider of CRM and decision support solutions. For more information, visit stayinfront.com. SYMYX TECHNOLOGIES INC. offers solutions that enable companies in life sciences, chemicals and energy, and consumer and industrial products to transform scientific R&D and achieve breakthroughs in productivity and return on investment. For more information, visit symyx.com.