New Tools, Services, and Products Designed to Improve Drug Development This special Drug Information Association section highlights the new and innovative products being offered by companies exhibiting at the upcoming 2011 DIA — 47th Annual Meeting in Chicago. (Note: briefs are listed alphabetically by company and include the booth number for the 2011 DIA exhibitor.) Almac and Exco InTouch to Deliver on Patient Compliance and ePRO Services The Almac Group’s Clinical Technologies Business Unit, a provider of IXRS (interactive voice and Web response) services relating to patient and drug supply management, and Exco InTouch, which specializes in patient recruitment, retention, compliance, and ePRO services, have formed an exclusive integrated patient management alliance focused on delivering patient management, compliance, retention, and ePRO service offerings to sponsors of clinical trials. The Almac-Exco InTouch offering serves a pressing need in the drug development process: engaging, retaining, and enhancing compliance of patients from the earliest stages of recruitment and throughout the course of a trial. The integrated solution will allow patients to receive messages for key elements of their required study conduct using SMS text messages, emails, or phone calls. Examples of messages include reminders to attend clinic visits or to fill out patient diaries, medication prompts, notices to attend appointments in a fasted state, to return unused medication, and encouragement messages to keep all patients motivated to participate in the clinical trial. The Almac-Exco InTouch alliance offers sponsors the benefit of alleviating clinical trial site personnel of significant administrative burdens and activities relating to protocol compliance. Moreover, it provides biopharmaceutical firms a way to ease a patient’s journey through the clinical trial process using familiar technologies that are both popular and ubiquitous, including phone, Web, text messages, and email. The solution keeps patients on track during a trial and offers them an “electronic tap on the shoulder" in their native languages to help drive compliance. As trials become increasingly more complex and global, the application of such cost-effective technologies to drive compliance and enhance clinical trial site productivity will serve a vital role in the drug development process. “The alliance between Almac and Exco InTouch provides sponsors with a practical, cost-effective solution to managing patients during a clinical trial," says Almac President Jim Murphy. “Our joint solutions will help enhance patient recruitment, retention, and compliance, three highly critical areas of concern for our clients." Tim Davis, CEO of Exco InTouch describes the relationship as “the perfect integration of complementary technology products. { For more information, visit almacgroup.com. DIA Booth No. 1711 { For more information, visit excointouch.com. DIA Booth No. 1429 CenterWatch Launches Virtual News Hub for Clinical Research Professionals CenterWatch, a publisher of clinical trials information, has launched its next-generation virtual news site, CenterWatch News Online. This easy-to-navigate, real-time online service features objective news reports covering timely stories and emerging trends in the global clinical research industry. CenterWatch News Online editors are covering breaking news about public and private companies. Breaking news beats include the study conduct industry, contract services industry, and the technology solutions industry. CenterWatch News Online features an “Awards and Advancement" section covering new contract award announcements and personnel changes. The virtual newsletter’s “Clinical Intelligence" section reports on newly initiated clinical trial activity, experimental treatment results by research phase, and FDA actions. The home page also includes a rotating “Featured Chart" sourced from original CenterWatch data. “News Online is a natural extension of our portfolio of editorial services that includes in-depth business analysis in The CenterWatch Monthly and journalistic coverage of major news developments in CWWeekly," says Joan Chambers, chief operating officer of CenterWatch. { For more information, visit CenterWatch News Online at centerwatch.com/news-online/. DIA Booth No. 1626 Health Decisions Launches HD360° Clinical Management System Health Decisions’ new HD360° Clinical Management System amplifies the capabilities of a study team by providing the real-time study metrics necessary for making key decisions about the course of a clinical trial. Unlike traditional web EDC and CTMS systems, HD360° combines flexible data capture and powerful data management with advanced reporting, collaboration, and sophisticated business intelligence. HD360° is a scalable, fault-tolerant, 21 CFR Part 11-validated environment that integrates a powerful CDMS with a CTMS and study collaboration and management portal. Intuitive, role-specific views enhance individual performance, and advanced management capabilities integrate and simplify budgets and payments, document management, resources, and audits. “We are pleased to unveil the latest HD360° clinical development management system, which provides information essential to effectively managing trials and programs," says Michael Rosenberg, M.D., president and CEO of Health Decisions. “The system collects data in real time and fully integrates all relevant elements — from site payments, to randomization, to drug supply, to adaptive monitoring — into a single platform that provides information specific to individual study roles." { For more information, visit healthdec.com. DIA Booth No. 523 ICON Releases Integrated Technology Solution for a Single View of Study Information ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries, has released ICONIK, an integrated technology solution that provides a single view of study information to both sponsor and CRO teams anytime, anywhere. ICONIK provides immediate knowledge to study teams by allowing near real-time access to critical safety and efficacy data, and analysis of these data in new and unique ways. ICONIK consolidates and standardizes data from multiple sources, including EDC, IVR, and ePRO, and combines the data with industry-specific analytical, reporting, and visualization tools to provide a single view of study information. Both CRO and sponsor teams can easily access study information and trends anytime, anywhere from a secure, Web-based interface. A 21 CFR compliant solution, ICONIK enables sponsors to more easily meet regulatory requirements by providing an online, end-to-end audit trail of study data for FDA submissions and post-submission queries. “Clients are looking to make better-informed and faster decisions and need real-time access to safety and performance data, rather than ad hoc programmed output, to make these decisions," says Kris Gustafson, senior VP, global data and technology services at ICON. “Using the information from ICONIK, we will help our clients in their drive to adopt more efficient and effective development programs." { For more information, visit iconplc.com. DIA Booth No. 1211 MedNet Solutions Releases iMedNet EDC MedNet Solutions, a global life-sciences technology solutions company specializing in clinical study management systems, has released iMedNet EDC, its next-generation electronic data capture (EDC) solution. iMedNet EDC delivers a practical, affordable, and easy-to-use Web-based solution that allows non-technical research personnel to build and manage their own clinical studies. iMedNet EDC, built from the ground up, is a brand new system based on MedNet’s extensive experience developing e-clinical solutions. Intuitive and efficient configuration tools, form libraries, and study replication features allow research studies to be set up in days, not weeks or months. iMedNet EDC’s software as a service (SaaS) pricing minimizes upfront fees and lowers overall costs, making it a practical solution for all study types. Easy-to-use designer tools allow sponsors, CROs, and independent investigators to quickly configure their own studies. “When it comes to iMedNet EDC, seeing is believing," says Brian Sweeney, VP, corporate business development and co-founder of MedNet Solutions. { For more information, visit mednetstudy.com. DIA Booth No. 425 OmniComm Releases V 4.1 of TrialMaster The latest release of OmniComm Systems’ TrialMaster electronic data capture software includes the TrialMaster Export Utility, a drag-and-drop tool used to define export data domains and map and transform the data collection model to industry standards, such as CDISC SDTM. TrialMaster v4.1 also features an enhanced query management system and redesigned reporting module with updated reports. { For more information, visit omnicomm.com. DIA Booth No. 203 Oracle’s Central Coding 3.0 Now Available Oracle has made available Oracle Health Sciences Central Coding Release 3.0, featuring expanded query management, automated workflows, and a customizable user interface that promotes greater productivity for clinical trial teams. { For more information, visit oracle.com. DIA Booth No. 211 Perceptive Informatics Introduces DataLabs 5.0 EDC Solution Perceptive Informatics, an e-clinical solutions provider and a subsidiary of Parexel International Corp., has released its DataLabs Electronic Data Capture (EDC) solution, which provides richer functionality to further streamline the clinical trial process. The DataLabs 5.0 EDC solution enables clinical trial sponsors to more efficiently manage the clinical development process from study design to collection and reporting of study data. Unlike other EDC solutions, the DataLabs EDC solution benefits from seamless interoperability with other systems in the Perceptive e-clinical suite to provide real-time data interchange and enable more effective decision making for clinical development programs. “The latest release of the DataLabs 5.0 EDC solution provides advanced features, powered by our e-clinical platform, which will set a new direction for how we look at study design and deployment across traditionally isolated systems," says Nicholas Richards, VP, product development, Perceptive Informatics. Newly enhanced features of the DataLabs 5.0 EDC solution, which has a user-friendly interface, include a powerful reporting engine, Web-based study design tool, and sophisticated search function, as well as advanced export functionality to easily extract EDC data. Perceptive has incorporated a level of convergence in its DataLabs EDC solution and its RTSM technologies that allows users to randomize and dispense medication from either system. With new dynamic forms and visit functionality available in the DataLabs 5.0 EDC solution, any changes that are made within the RTSM technologies will automatically trigger within the EDC system a dynamic patient visit to occur. This capability effectively supports mid-study protocol amendments commonly required in adaptive trials. { For more information, visit perceptive.com. DIA Booth No. 1627 PHT Expands ePRO System with Web-Based NetPRO PHT Corp., a provider of ePRO solutions, has released NetPRO, a browser-based ePRO and eClinRO system that collects patient data via the Internet. NetPRO enables researchers to access a larger global patient population while reducing the costs of large Phase IV and extended postmarket studies. Sponsors can use NetPRO to collect PRO data for regulatory submissions and label claims as well as for postapproval safety, observational, and registry studies. By leveraging a patient’s own technology, NetPRO offers ease of use and cost benefits compared with other types of PRO methods. PHT President and CEO Phil Lee says: “NetPRO is an extremely important e-clinical solution, as it makes ePROs available to a much broader audience. It enables researchers to easily collect high-quality patient-reported outcome data directly from patients across the clinical development lifecycle to better track the efficacy of new therapies, in addition to assessing the real-world outcomes and long-term safety of approved medicines." NetPRO sends data to StudyWorks — PHT’s backend system and Web portal — for data review, management, and analysis by trial stakeholders. NetPRO is easily accessible through an Internet browser and can be used on patient-owned devices that connect to the Internet including smartphones, iPads, and Netbooks. NetPRO’s key benefits include improved patient retention by simplifying the process of data collection; easy availability at both the site and patient’s location, with ease of use and confidentiality assurance to elicit honest patient answers; timely and verified data entry with accurate timestamps, and no unplanned recall bias or prospective responses; and increased brand exposure for patients and clinicians participating in a trial, with a fully configurable user experience for patients and doctors participating in the trial. NetPRO meets the ePRO System Requirements set forth in the FDA PRO Guidance and Draft eSource Guidance. { For more information, visit phtcorp.com/ resources/insightsdec10. DIA Booth No. 1612 Thomson Reuters Enhances MetaCore Solution with Validated Biomarker Data Thomson Reuters is now offering access to its validated biomarker content within MetaCore, the company’s pathway analysis and biomarker discovery solution. The enhanced access will provide users of MetaCore with additional gene and biomarker data including biomarker name, type, and role as well as gene name within their search results. The additional data are drawn from Thomson Reuters Integrity, an industry source of validated biomarker data, with more than 7,000 biomarkers and 200,000 related uses. The development provides deeper insight into potential biomarkers identified in MetaCore, including previous utility, extent of research already performed, and level of confidence in that biomarker. “Biomarkers are playing an increasingly important role in the development of new drugs and treatments," says Jon Brett-Harris, executive VP, Thomson Reuters. “This latest addition to MetaCore marks the first step toward a comprehensive solution for biomarker discovery, hypothesis testing, and validation, enabling scientists to go from basic ‘omics’ data to biomarker insight in hours." MetaCore is an integrated solution and software suite for pathway analysis of experimental data and gene lists. { For more information about MetaCore, visit genego.com/metacore.php. DIA Booth No. 1617 Veeva’s iRep CRM/CLM Application Now on the iPad Apple’s iPad2 has opened up exciting possibilities for life-sciences sales representatives using Veeva Systems’ recently launched irep — the industry’s first iPad CRM/CLM cloud application. Designed from the ground up to leverage all of the advantages of the iPad, iRep leverages all of the device’s new enhancements, including live video chat, plug-and-play projection, and faster rendering of HTML 5 content thanks to an updated Safari browser, dual code processor, and twice as much RAM. “It’s hard to imagine that pharma technology could get much more exciting than it already is right now, but it has," says Brian Longo, senior director of product development at Veeva. “Apple’s upgrades to the industry’s most popular new device ratchet up its significance up and, with iRep, the possibilities seem endless for life-sciences companies. We’re really excited to see our customers leverage cool new features like FaceTime." Pharma sales reps using Veeva’s iRep on the iPad2 will have access to FaceTime, allowing them to instantly connect face-to-face with other members of the commercial team during a meeting with a physician. For example, if a physician asks a difficult question that the rep cannot completely answer, the rep can tap his iPad2, connect live with one of the pharma eutical company’s on-call product experts such as a key opinion leader manager and answer the physician’s question via video chat for a more interpersonal and instant experience. { For more information, visit veevasystems.com/iRep. Visit DIA?Booth 813
