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PharmaLinx Launches Industry Web Portal Professionals who operate in the pharmaceutical, biotechnology, and medical-device sectors, as well as those who provide services and tools to the industry, now have a single source to find targeted information related to their fields. The new portal, AccessFYI, is being developed by PharmaLinx, publisher of PharmaVOICE magazine and VIEW publications, and powered by ePharmaSolutions’ technology. PharmaLinx communicates with life-sciences industry professionals through its various print vehicles, as well as its PharmaVOICE Webcast Network. Based on feedback from these individuals, it became clear that one of the industry’s most critical needs was to have one place to quickly find the right information in the most efficient manner possible. By logging onto accessfyi.com, individuals now can go to one place for everything they need to succeed in the life sciences. There is no cost to use the portal, which means high adoption rates, and the content is comprehensive, which means there’s something for everyone in the industry — from intern to CEO. The AccessFYI portal contains: • U.S. job listings in the pharmaceutical, biotech, medical-device, and supplier fields • Industry reports, articles, books, journals, magazines, and white papers • A collection of RSS feeds, blogs, and e-newsletters • Multimedia resources: Podcasts, Webcasts, and videos • Live and archived Web seminars • Conference and workshop listings and registrations • Press releases and other industry-related information AccessFYI, which is in beta launch, has benefits for content partners; there is free exposure of insights and services content, as well as a reseller program for paid content. AccessFYI offers advertising and sponsorship opportunities that fit the most modest budgets or aggressive campaigns. AccessFYI was designed from the ground up with the life-sciences professional in mind. As we continue to expand the platform and increase partner participation, we will be extending the portal to handhelds, mobile phones, and other devices, says Enrico DePaolis, President and Chief Operating Officer, ePharmaSolutions. The industry has done a great job supporting the consumer with comprehensive health information on the Web. AccessFYI was designed to be an integral part of the daily work flow. It’s definitely a go-to Website for the industry, says Daniel Limbach, Managing Director of AccessFYI.
Parexel Expands Patient Recruitment Services Parexel is making patient recruitment and retention strategy, planning, and execution more effective for clinical-trial sponsors with an expanded offering that includes an expert recruitment team supported by new technology. To streamline and analyze the disparate factors across the organization that can impact Last Patient In (LPI) recruitment goals, Parexel has organized a global Start-up and Accelerated Recruitment Team (START). START relies upon a suite of proprietary technologies and data assets to more accurately plan for recruitment milestones. The Scenario Planning and Recruitment Calculator (SPARC) integrates data from across the organization to help drug sponsors avoid costly delays caused by slow recruitment or poor patient retention. With these data, START also is able to implement preplanned contingencies based upon ongoing information, helping to avoid potential problems. Another critical aspect of the expanded recruitment capabilities is an enhanced investigator database that is used in conjunction with the SPARC to plan trials and identify high potential investigators. In other company news, the company released an enhanced version of its CTMS IMPACT technology with improved site management and monitoring capabilities. The IMPACT software comprises several Web-based modules designed to deliver practical and tangible results, decreasing the time, cost, and risk associated with the development of new products. Successfully achieving LPI milestones requires using all of the levers that Parexel, as a global CRO, has at its fingertips, says Mark A. Goldberg, M.D., President of Clinical Research Services and Perceptive Informatics at Parexel. ClinPhone Offers Solution for Trial Supply Management ClinPhone Compact is a service specifically created to meet the needs of many conventional study designs. It is a ready-made application that allows speedy and cost-effective development of interactive voice response (IVR) and interactive Web response (IWR) solutions for randomization and trial-supply management. ClinPhone Compact facilitates quick deployment of IVR/IWR functionalities. The system features comprehensive functionalities enabling biopharmaceutical sponsors to perform central randomization, emergency code break, medication dispensation, and site and depot supplies management. These functions are combined with real-time study progress reporting. The solution minimizes the need for programming, testing, and validation while allowing for essential study-specific customization. Customers enjoy 24/7 global support, unlimited language capabilities, and a toll-free network of 82 countries. ClinPhone has also launched its newly designed Website. The Website has been updated to reflect ClinPhone’s changing market position following the recent acquisition of DataLabs. The library section of the Website resource features all of ClinPhone’s published materials, including white papers, editorial articles, and press releases. We have introduced ClinPhone Compact in response to a gap in the marketplace for provision of randomization and trial supply management, says Dr. Bill Byrom, VP of Product Management at ClinPhone. Phase Forward Offers Next-Generation Clinical Study Design Phase Forward has introduced a clinical trial data management product, Central Designer, which is designed to take the complexities out of the trial study design build process. It provides an easy-to-view graphical layout and an efficient way to incorporate standards. Using Central Designer, companies can reduce the time it takes to develop, review, and approve a study on the Phase Forward InForm integrated trial management (ITM) electronic data capture (EDC) platform while improving data quality. As the use of EDC for clinical studies continues to increase, life-sciences companies are re-examining their processes in the context of this technology to maximize their operational efficiencies. The process required to transform a study protocol into a completely built EDC study is critical but time-consuming. With the Central Designer product, the design, programming, data management, and translation elements called for in study set-up are all in one centralized system. Organizations can export or import study design components from any Operational Data Model (ODM)-compliant source from within Central Designer. Additionally, the company has introduced a submission checking service based on its Web submission data manager (WebSDM) application. The application was developed under a cooperative R&D agreement between the FDA and Phase Forward’s Lincoln Technologies safety division. WebSDM gives organizations a means for testing FDA submissions for compliance with the Clinical Data Interchange Standards Consortium’s (CDISC) Study Data Tabulation Model (SDTM) standard for human clinical trials. The Submission Checking Service makes WebSDM data validation services broadly available as a hosted service offering, with a rapid contracting and access process. The hosted service produces a comprehensive report detailing all errors identified by WebSDM. Phase Forward CDISC specialists then conduct a two-hour interactive review session using the customer’s own data to discuss identified errors, leveraging the same advanced reporting, visualization, and review capabilities within WebSDM that are already available to FDA reviewers. This allows the manufacturer to examine data in the same environment FDA reviewers will use. The service also includes customer access to the hosted data using the WebSDM error management and review tools for 15 days. Many life-sciences companies are seeking ways to shorten the EDC design-and-build process to expedite trial start dates, says Bob Weiler, President and CEO, Phase Forward. Fast Track Systems Offers TrialSpace Product Extensions Fast Track Systems has launched product extensions to TrialSpace Grants Manager and TrialSpace Crocas that permit sponsors to actively manage investigator site and CRO contracts. The products, Grants Manager Own and Crocas Own, provide a secure browser interface for contracting professionals to analyze their past agreements with sites and CROs. Each application permits users to evaluate these contracts along one or more of the following dimensions: protocol number, specific site, individual investigator or CRO, phase, therapeutic area, geography, and time period. Custom management reports can be created and archived information searched to readily determine how much has been paid for work activities. Additionally, the document retrieval functionality enables related agreements and unique contractual provisions to be archived and referenced. Both Own products allow sponsors to capture contract information accurately and effectively across the hundreds, even thousands, of contractual obligations involved in managing investigative sites and CROs. The Own products provide organizations with a simple-to-use, auditable, online environment for archiving, retrieving, and analyzing their own clinical-trial contracts with investigators and CROs, says Ed Seguine, CEO of Fast Track Systems. SAS and Medidata Streamline Access to Clinical Study Data SAS and Medidata Solutions have announced the integration of Medidata Rave with SAS Drug Development. Combining the operational and clinical data management features found in Medidata Rave with the analytics and data integrity features available in SAS Drug Development, the pharmaceutical industry has an example of a next-generation platform capable of supporting the transactional requirements of adaptive trials and ultimately the realization of personalized medicine. Traditionally, sponsors have collected clinical-trial data using paper-based systems. At the end of the study, researchers would bring all of the clinical data together in a standalone clinical data management system for reconciliation and cleaning and then transfer the data into an analysis environment for decision making. Through this integration available to customers worldwide, data collected and managed in Medidata Rave is immediately accessible through SAS Drug Development, along with other data gathered in the R&D process. Sponsors benefit from streamlined access to study data on one uniform, regulatory-compliant data management path. Medidata Rave and SAS Drug Development represent two halves of the end-to-end decision-making process, says Glen de Vries, chief technical officer of Medidata Solutions. Medidata Rave and SAS Drug Development represent two halves of the end-to-end decision-making process, says Glen de Vries, Chief Technical Officer of Medidata Solutions. This integration offers customers an opportunity to revolutionize clinical development by speeding data transparency from patient to p-value, says Jason Burke, Worldwide Director of the SAS Health and Life Sciences Global Practice. etrials Offers Updated EDC Solution etrials Worldwide has launched an e-clinical solution, an advanced EDC 2.0 that enables a quick-start study development and deployment along with enhanced reporting and analytics capabilities through user-friendly, adaptable design tools. EDC 2.0 builds upon the company’s existing Web-based software as a service (SaaS) platform to integrate with etrials e-diary and IVR solutions, providing the most comprehensive and scalable e-clinical solution. The solution simplifies study deployment, provides more function and design control, enhances the users’ overall experience and workflow, and offers powerful new reporting and pattern capabilities. The new version also makes incorporating third-party data (i.e., external lab and safety/risk management) simpler, eliminating costly and time intensive processes. It is fully 21 CFR Part 11 compliant with comprehensive audit trails. EDC 2.0 builds upon the company’s existing Web-based software. I-many Unveils Contract Management Software Suite I-many has introduced its Contract Management Suite for Life Sciences. Built on I-many’s services-oriented architecture, the suite spans the contract management continuum, from the core functions of contract authoring and compliance to sophisticated analytics and business intelligence, in an integrated platform. With the continued introduction of complex government programs and regulations, such as the recent roll-out of the Deficit Reduction Act and Medicare Part D, the strategic importance of contract management has greatly increased. The core modules of the suite include several solutions specifically developed to handle the industry’s most pressing issues including: • Contract Authoring: An automated tool for the creation, approval, storage, and management of sponsor contracts. • CARS NG: A system for managing rebate contracts and chargebacks for the life-sciences industry providing core functionality common to all commercial contracting operations. • Medicaid Rebates: Products that automate the management and clerical tasks of the government-mandated Medicaid Drug Rebate Law for both federal and state programs. • Government Pricing: A tool for calculating, monitoring, and complying with all government-mandated pricing and reporting requirements established by government programs. • Validata: For rebate claims validation down to the prescription-level that can be used for managed care, Medicare, and Medicaid rebate processing. • Medicaid Analytics: Enhances and streamlines the Medicaid contract analysis process and allows life-sciences companies to perform various “what if” analyses on Medicaid, supplemental, and state programs. • CARS BI: An advanced reporting tool using business intelligence to extract a variety of comprehensive reports and information. The I-many Contract Management Suite for Life Sciences is a major landmark for I-many, says John Rade, I-many’s President and CEO. NXLevel Solutions Launches PharmaCertify Off-The-Shelf Training Courses NXLevel Solutions Launches PharmaCertify Off-The-Shelf Training Courses Organizations are realizing that an off- the-shelf e-learning solution that focuses on appropriate content, and one that can adapt to their specific needs, provides an effective solution faster and with lower costs than custom learning, says Bob Christensen, Chief Development Officer of NXLevel Solutions. PharmaVigilant Releases Clinical Data Warehouse PharmaVigilant has released I-Warehouse, the first commercially available clinical data warehouse in the industry. I-Warehouse enables companies to store and access clinical-trial information in one repository. I-Warehouse can import existing trial data that was generated in other systems, either paper or other EDC systems via its import utilities. This allows pharmaceutical sponsors to use any company for the generation of the data capture and provides them with complete control of their data during and after the conclusion of their clinical studies. Sponsors will be able to use the InSpire Reporting Tool to create standard reports or ad hoc reports on demand. “The focus of the industry has shifted from data collection to reporting and from individual studies to complete programs,” says James DeSanti, CEO of PharmaVigilant. “Access to data is critical in providing better inputs to strategic and tactical decisions facing every clinical team.” I-Warehouse can import existing trial data that was generated in other systems. Liquent Expands Consulting Services to eCTD Submissions Liquent Direct, Liquent’s regulatory outsourcing service, has introduced an on-demand regulatory consulting option for Liquent software clients, and a comprehensive package of authoring templates designed to streamline and organize the documentation development process for new drug applications to assist with the move to electronic common technical document (eCTD) format. Smaller companies without the infrastructure to produce eCTD benefit by having a team of regulatory experts available to them, coupled with the necessary tools to help them submit in eCTD format. “Because the FDA has withdrawn its 1999 electronic submission guidance, any company wishing to submit to the FDA electronically after Jan. 1, 2008, must do so in eCTD format,” says Jim Nichols, Liquent’s VP of product strategy and marketing, at Thomson Scientific. Smaller companies without the infrastructure to produce eCTD benefit by having a team of regulatory experts. R&R Introduces Professional Networking Site for Physicians R&R Healthcare Communications has unveiled a professional networking Website specifically designed for physicians and other healthcare providers. ClinicalVillage.com provides a space on the Internet where medical professionals can connect and share their experience with their peers using Treater Talk forums where colleagues can engage in discussion and ask clinical questions. Other features of the site include daily blogs by recognized thought leaders and researchers, personal pages, and groups where participants can connect with colleagues from medical school, residency, geographic area, or share files. ClinicalVillage.com represents a major innovation in how healthcare professionals can communicate, says Harold A. Kessler, M.D., Professor of Medicine and Immunology/ Microbiology at Rush University Medical Center in Chicago, and Editor-in-Chief of ClinicalVillage.com Formedic Introduces New Category of Product Promotion Formedic has introduced SymCue, a method to deliver symptom-cued pharmaceutical marketing during the patient-physician encounter, before the prescription decision is made. Branded messaging appears on the patient’s Medical History Questionnaire (MHQ), a document handled by the patient and physician during the office visit. The form captures the chief complaint and symptoms via a logarithm-driven, point-and-click process and delivers related messaging from a pharmaceutical advertiser cued to the symptoms. “Formedic SymCue is much more powerful than direct-to-consumer advertising because it creates direct-to-patient marketing opportunities at the time the patient experiences symptoms,” says Formedic SymCue General Manager Bruce Rowan. “It also puts the brand name in front of the physician as he or she decides what medication to prescribe. This system offers a targeted method available to reach both physicians and patients at the most crucial moments in the prescribing process.” Additional advantages to pharmaceutical advertisers include on-screen exposure as the patient inputs data, as well as the opportunity to increase traffic to product Websites by providing a URL. Formedic MHQ is available free of charge to any medical practice in the United States. The company is in the process of marketing the program to its customer base of more than 188,000 physicians. The system captures patients’ history and current symptoms before the exam, and the document it produces becomes part of the permanent medical record. Used on a standard PC in the waiting area or exam rooms, or accessible online from a patient’s home or office, MHQ prompts patients through a series of specialty-specific questions based on their chief complaint. Developed with input from a variety of physicians, including doctors affiliated with the Mayo Clinic, Johns Hopkins, Duke, and other prestigious institutions, the program accesses 5,000 unique symptom-based question sets, driven by a series of algorithms. This same process cues the system to deliver a specific pharmaceutical message based on the chief complaint or symptomatology. MHQ has capabilities to address the needs of a numerous medical specialties. Formedic SymCue is much more powerful than DTC advertising because it creates direct-to-patient marketing opportunities at the time the patient experiences symptoms. PRA International Expands Electronic Publishing Capability PRA International offers a fully compliant technology option for sponsors to file electronic common technical documents (eCTD) with regulatory agencies. The move is in preparation for the FDA’s plan to require all electronic submissions to be in eCTD format by Jan. 1, 2008. “The United States and several European Union countries accept the CTD in electronic format,” says Cindy Kirk, VP of regulatory affairs at PRA. “With many countries, including Japan, moving to electronic submissions, strategic planning and state-of-the-art technology are keys to success in today’s market.” PRA’s solution enables eCTD submissions but also supports paper submissions in countries where this is still required. InSight Publisher is integrated with Image Solutions’ Adobe Plug-in ISIToolBox Pharma Edition to provide PRA’s clients a full spectrum of regulatory publishing resources. Electronic submissions facilitate faster and more efficient regulatory reviews, potentially shortening the time to approval, says Cindy Kirk, VP of Regulatory Affairs at PRA. Verticals onDemand and MediMedia Join Forces for CRM Solution Verticals onDemand and MediMedia Information Technologies have integrated their solutions to provide pharmaceutical managed care teams with the first on-demand CRM solution pre-loaded with formulary data. The data are automatically updated through Web services and Salesforce.com API. The Software as a Service (SaaS) CRM solution makes it easy to load, update, and route formulary data, empowering managed care account managers with current formulary details. In addition, data updates and system assimilation occur automatically, eliminating the need for IT staff intervention. “Getting the right formulary data at the right time to managed care account managers is key to maintaining and improving the pharmaceutical companies’ competitive position,” says Brian Bamberger, senior VP of business development for MediMedia Managed Care Group. “With Verticals onDemand’s new system, companies will undoubtedly see formulary status improvements and better understand how much managed care impacts their businesses.” Change is hitting the healthcare industry like a tidal wave, says Matt Wallach, VP of Sales and Marketing for Verticals onDemand. Symfo Adds New Feature to SymPhone eDiary Symfo’s SymPhone eDiary is now equipped for either wireless or landline data transfers. Patients have no need for additional equipment, such as modems, and allows patients without GSM coverage to use a landline to send their information. “By adding the dual interface to the eDiary for data transmissions, we can give our customers absolute peace of mind with regard to how patients send their data,” says Serge Bodart, Symfo’s CEO. Symfo’s SymPhone eDiary is equipped for wireless or landline data transfers. Prosanos Software Releases Product for Evaluation of Drug Safety ProSanos has released Clærity, a next-generation software product that can be used to explore questions about the safety of a particular drug, class of drugs, or therapeutic area. Clærity is a Web-based product incorporating a state-of-the-art data mining algorithm to detect potential drug safety signals — adverse drug reactions reported at higher than expected frequencies in databases, such as the FDA’s adverse event reporting system (AERS) database. Clærity has been optimized to detect and investigate potential signals hidden within the background rate of common medical conditions, for example myocardial infarction, stroke, seizure, as well as rare, often drug-induced conditions that are the primary focus of current safety data mining tools (e.g., rhabdomyolysis, Stevens-Johnson syndrome). Results are generated in seconds, facilitating interactive drug safety investigation. The presentation of the data is visual and intuitive, providing information in a way that is compelling and easy to understand even for those users who are not statisticians. ProSanos has released Clærity, a next-generation software product. Follow up AccessFYI, Titusville, N.J., is a Web portal designed and developed by PharmaLinx LLC and powered by ePharmaSolutions’ technology deisgned specifically for the life-sciences industry. For more information, visit accessfyi.com. ClinPhone Plc., Princeton, N.J., is a specialist clinical technology organization working with global biotech and pharmaceutical organizations. For more information, visit clinphone.com. epharmasolutions, Conshocken, Pa., is a clinical and medical application services provider that helps companies improve the way clinical trials are launched, physicians are educated, and thought leaders are managed. For more information, visit epharmasolutions.com. eResearchTechnology, Philadelphia, is a provider of technology and services to the life-sciences industries. For more information, visit ert.com. etrials Worldwide Inc., Morrisville, N.C., provides e-clinical software and services to pharmaceutical, biotechnology, and medical device companies, as well as CROs. For more information, visit etrials.com. Fast Track Systems Inc., Conshohocken, Pa., provides clinical-trial software and professional services to pharmaceutical and biotechnology companies. For more information, visit fast-track.com. First Consulting Group, Alpharetta, Ga., is a provider of outsourcing, consulting, systems implementation, and integration services. For more information, visit fcg.com. Formedic, Somerset, N.J., provides point-of prescription marketing, including patient record forms, prescription pads, telephone message pads, referral forms, work, school slips, and appointment cards. For more information, visit formedic.com. Healthcare Technology Systems Inc. (HTS), Madison, Wis., develops clinical interactive voice response (IVR) systems to collect data directly from patients for pharmaceutical companies, healthcare organizations, and researchers. For more information, visit healthtechsys.com. I-many Inc., Edison, N.J., provides contract management software and services enabling businesses to manage the entire contract life cycle. For more information, visit imany.com. LabPas CT, Montpelier, Vt., manages Phase I clinical trials, from recruiting through export to EDC. For more information, visit labpas.com. Liquent, Philadelphia, part of The Thomson Corp., provides software, information products, and related services for the life-sciences industry. For more information, visit liquent.com. Medidata Solutions, New York, is a global provider of electronic clinical data capture, management, and reporting solutions. For more information, visit mdsol.com. MediMedia Information Technologies, Yardley, Pa., a division of MediMedia USA, is a provider of plan specific formulary data. For more information, visit mminfotech.com. NXLevel Solutions, Hopewell, N.J., develops technology-based learning solutions. For more information, visit nxlevel.com. Octagon Research Solutions Inc., Wayne, Pa., offers a suite of regulatory, clinical, process, and IT solutions to the life-sciences industry for the electronic transformation of clinical R&D. For more information, visit octagonresearch.com. Parexel International Corp., Waltham, Mass., is a global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications, and consulting services. For more information, visit parexel.com. PharmaVigilant, Westborough, Mass., offers solutions to address the complexities of global clinical research. For more information, visit pharmavigilant.com. Phase Forward, Waltham, Mass., provides integrated data management solutions for clinical trials and drug safety. For more information, visit phaseforward.com. Phoenix Data Systems Inc., King of Prussia, Pa., provides e-clinical technology and full service EDC. For more information, visit phoenixdatasystems.net. PRA International, Reston, Va., is a CRO that delivers service, program-level therapeutic expertise, and easy global access to knowledge. For more information, visit prainternational.com. ProSanos Corp., Harrisburg, Pa., provides products and services for the integration, analysis, and management of healthcare-related data. For more information, visit prosanos.com. Publicis Healthcare Communications Group, Lawrenceville, N.J., is a global healthcare communications group. For more information, visit publicishealthcare.com. R&R Healthcare Communications Inc., Oldsmar, Fla., develops and designs medical educational programming. For more information, visit rrhealthcare.com. The SAS Institute Inc., Cary, N.C., is a business intelligence and analytical software and services company, and the parent company of SAS Drug Development that provides a centralized, integrated system for managing, analyzing, reporting, and reviewing clinical research information. For more information, visit sas.com. Symfo, Boston, is an international organization specializing in ePRO solutions, enabling study sponsors to implement electronic patient diaries in all phases of clinical trials and post-marketing studies. For more information, visit symfo.com. Verticals onDemand, Pleasanton, Calif., is a privately held company that delivers on-demand CRM solutions for specific industry segments. For more information, visit verticalsondemand.com.