2012 DIA Preview

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Taren Grom, Editor

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2012 DIA Preview

New tools, services, and products to improve drug development from DIA exhibitors.

This special Drug Information Association section highlights news as well as new and innovative products being offered by companies exhibiting at the upcoming 2012 DIA, the 48th Annual Meeting, in Philadelphia June ­­­24-28. This year’s theme is Collaborate to Innovate, which highlights trends in the industry, namely the need for the industry to partner to bring about truly new therapies. The DIA also is collaborating with new partners, including the Bill & Melinda Gates Foundation and other organizations, to provide content that speaks to key trends affecting global development. In an exclusive podcast, Craig Lipset, head of clinical innovation, development operations within worldwide research & development, Pfizer, and DIA chair, provides an overview of the 2012 DIA Conference Preview. New Tools Aptiv Updates Adaptive Design Simulation Software Aptiv Solutions has released the latest version of its adaptive trial software: AddPlan 6.0 PE. This version provides the statistical methodology, simulation, and analysis tools for adaptive clinical trials that includes an enrichment design and is the first fully validated adaptive design software with this functionality to be made available to the market. “It is well-recognized that innovation in clinical trial design is a critical component of modern-day product development,” says Pat Donnelly, chairman and CEO of Aptiv Solutions. { For more information, visit aptivsolutions.com. DIA Booth No. 2815 ArisGlobal Releases New Versions of XEVMPD-Compliant Solutions ArisGlobal has released fully XEVMPD compliant solutions: Register 5.2.5 and agXchange RSM 5.4. These solutions offer customers product information management, tracking, and submission technology able to automate the submission of the required data to meet the EMA’s XEVMPD compliance requirements. The new offering enables customers to: manage and automate the process of submission for all XEVMPD data; validate product information entered for compliance with all XEVMPD business rules according to the latest EMA guidelines; manage and automatically merge product information documents that support product and substance information submissions; and define high-level strategic and tactical plans for regulatory management. “Our customers will have the benefit of leveraging this technology to help automate their processes,” says Wim Cypers, VP of regulatory affairs with ArisGlobal. { For more information, visit arisglobal.com. DIA Booth No. 2113 CCCRI Updates System for Remote Monitoring of Trials Cape Cod Clinical Research (CCCRI) has launched TrialDOCS v2, a Web-based document management solution that has been fully validated in compliance with the FDA’s 21 CFR Part 11. TrialDOCS helps investigative sites, pharmaceutical, and biotechnology companies access, manage, and track all of the regulatory and source documentation required for clinical trials to be monitored remotely. “Remote monitoring is a concept whose time has finally come to the United States,” says William Baker, president and founder of CCCRI. “By providing organizations with a secure system to manage all documentation in a clinical trial — one of the most inefficient processes of clinical research — remote monitoring can be successfully realized, with monitoring costs reduced by 30% to 50%.” { For more information, visit cccri.com. DIA Booth No. 2409 CDISC Releases New Protocol ­Representation Toolkit The Clinical Data Interchange Standards Consortium (CDISC) has released the first iteration of a Protocol Representation “Toolkit” for clinical research. The purpose is to make it easy for authors of the research plan or protocol to reap the benefits of the Protocol Representation Model (PRM), which has been developed over the past decade by global clinical research experts from academia, industry, and government. The current release of the Toolkit includes a standard Study Outline Template in MS Word format, a standard list of Study Outline Concepts, and a complete mapping of the Study Outline Concepts to both the Biomedical Research Integrated Domain Group (BRIDG) model and the CDISC Study Data Tabulation Model (SDTM) Trial Summary (TS) Domain. “This is what has been missing from the PRM since Version 1.0 was released in 2010; it provides a means for protocol authors to use the model without having to be technology experts,” says Rebecca Kush, president and CEO of CDISC. { For more information, visit cdisc.org. DIA Booth No. 1525 CenterWatch Launches Online Data Library CenterWatch has released its new online Data Library. The online resource features hundreds of charts and tables and is organized into seven chapters covering all aspects of the clinical research enterprise. From global economic trends and clinical research practices to partnerships, drug development pipelines, and performance, the library is a compilation of data from various sources including proprietary primary and secondary research and analysis performed by CenterWatch staff. “In a rapidly changing marketplace, critical and highly accessible data are needed for competitive analysis and strategic planning,” says CenterWatch Chief Operating Officer Joan Chambers. { For more information, visit centerwatch.com. DIA Booth No. 1736 Comprehend Systems Releases Latest Version of Clinical Data Visualization Platform Designed to help clinical researchers overcome the ongoing challenge of accessing clean, real-time data and reports, Comprehend Clinical 1.1 from Comprehend Systems includes a range of new features that enable sponsors to meet increasing regulatory requirements and leverage industry standards to easily share data across all systems in the clinical trials process. “From sponsors and CROs to EDC and CTMS companies, everyone is looking for ways to understand how to reduce costs and increase efficiencies, but are still hitting expensive and time-consuming roadblocks when it comes to accessing and sharing the data they need to make critical decisions,” says Rick Morrison, CEO of Comprehend Systems. { For more information, visit comprehend.com. DIA Booth No. 2516 CRF Health Adds Android Mobile Device Support CRF Health has enhanced its TrialMax suite eCOA (e-clinical outcomes assessments) software platform to support Android mobile devices in the collection of outcome measures in clinical trials. TrialMax Touch Android will offer pharmaceutical customers and investigator sites a broader toolbox for delivering eCOA solutions in the clinical research space. “Android devices offer an excellent user experience on high-resolution color screens, with expanded font and language support and global data sending options,” says Pekka Keskiivari, chief technology officer, CRF Health. { For more information, visit crfhealth.com. DIA Booth No. 3306 Medidata Issues a New Release of Medidata Balance Medidata Solutions has issued a new release of Medidata Balance, a randomization and trial supply management (RTSM) application, which is part of Medidata’s comprehensive clinical cloud platform. Balance now provides block randomization methodology in addition to the allocation methodology it previously offered. These two methodologies cover the large majority of the range of developers’ requirements for randomly allocated clinical trials. “With the broader capabilities in Balance’s new version, sponsors and CROs can now choose either permuted block or dynamic allocation randomization within our low-risk, easy-to-deploy, and easy-to-use cloud-based randomization solution,” says Glen de Vries, president of Medidata Solutions. { For more information, visit mdsol.com. DIA Booth No. 3101 MedNet Provides Cloud-Based ­E-Clinical Solution MedNet Solutions has introduced iMedNet EDC, the company’s latest software-as-a-service solution that allows customers to quickly, easily, and affordably create their own studies. iMedNet EDC is securely hosted on the Internet via the MedNet cloud, clusters of cost-effective servers that can easily be scaled to support studies of any size. iMedNet EDC supports numerous industry standards (CDISC, HIPAA, 21 CFR 11, and GCP), and can easily be accessed using the current versions of all the major browsers. { For more information, visit mednetstudy.com. DIA Booth No. 3017 OpenQ Delivers Salesforce Solution OpenQ for Salesforce is now available on the Salesforce.com App Exchange. The new app brings together OpenQ’s expertise and solutions for harnessing the power of medical networks with the reliability, power, and reach of the Salesforce.com platform. OpenQ for Salesforce enables life-sciences companies to effectively engage with key opinion leaders (KOLs) and stakeholders in a compliant way. “Integrating our technology and data services with force.com gives customers the best of both worlds — a social, mobile, and compliant app built on a trusted and powerful platform,” says Jim Zuffoletti, president of OpenQ. “We were able to build an app that allows customers to perform critical planning, interact and evaluate activities using processes, and manage profiles and workflows, all with built-in compliance protection.” { For more information, visit openq.com. DIA Booth No. 2740 Perceptive Informatics Launches Site Inventory Module Perceptive Informatics has introduced a new site inventory management module of its ClinPhone randomization and trial supply management (RTSM) solution. The solution now offers validated randomization methods, automated inventory control, dispensing and titration management, emergency code break capabilities, and supply reporting. This new Web-based module is designed to improve the efficiency of clinical trial management by tracking the movement of supplies at clinical sites in real time and streamlining workflow for site personnel. “With greater clinical trial complexity, sites require the necessary tools for seamless access to data in order to make better, faster decisions,” says Nick Richards, VP, product management, Perceptive Informatics. { For more information, visit perceptive.com. DIA Booth No. 2125 Thomson Reuters Launches Mobile ­Oncology Decision Support ­Solution The Intellectual Property & Science division of Thomson Reuters has launched a new oncology application for mobile tablet devices, already in use by AstraZeneca executives. The rich visualization dashboard leverages content from Thomson Reuters Cortellis. The solution provides a series of oncology-based clinical dashboards that provide competitive information that quickly answers common questions in drug development. It is platform independent and accessible via the Internet. Mobile tablet-based devices are the primary method used for accessing the solution. “The ability of drug companies to quickly find the most relevant research data and clinical information for their oncology studies, in meetings, on the move, or at the bench, will allow them to make faster business decisions and focus on areas where there is unmet need,” says Wendy Hamilton, senior VP at Thomson Reuters. { For more information, visit thomsonreuters.com. DIA Booth No. 3001 Veeva Adds Sample and ­Promotional Item Ordering to CRM System Veeva Systems has enhanced Veeva CRM with sample and promotional item ordering capabilities, enabling sales representatives to easily replenish their samples and promotional materials through the same system they already use to manage their customer relationships. Including this capability in Veeva CRM helps save life-sciences companies hundreds of thousands of dollars in application development, integration, and maintenance costs while also helping to control sample and promotional item allocation. “Samples and promotional items are costly for pharmaceutical organizations so it’s naturally prudent for companies to want to closely monitor their distribution,” says Brian Longo, senior director of product management, Veeva. { For more information, visit veevasystems.com. DIA Booth No. 1445 Virtify, Huron Life Sciences Team Up on Disclosure Solutions Virtify and Huron Consulting Group’s life sciences practice have formed an alliance that combines Virtify’s structured content management software solutions and Huron Life Sciences’ implementation and business process expertise to help improve clinical trials transparency and reporting for academic and research organizations and pharmaceutical companies. “Clients looking to improve the quality and timing of their disclosures to regulatory authorities can now combine the robust technology of Virtify and the expertise of Huron Life Sciences in addressing clinical trial disclosure,” says Matthew Lester, managing director for Huron Life Sciences. “Our combined strengths not only help these institutions improve compliance, but allow their trial results to be published in industry medical journals.” { For more information, visit huronconsultinggroup.com. { For more information, visit virtify.com. DIA Booth No. 1842 What’s New Catalent Extends Analytical ­Solutions in the United Kingdom Catalent Pharma Solutions has opened new development and analytical solutions laboratories at its facility in Swindon, U.K. From this new laboratory suite, Catalent offers expert analytical testing, development support, and regulatory services to pharmaceutical and biopharmaceutical companies. The laboratory suite incorporates expanded, state-of-the-art facilities for the storage and testing of controlled and cytotoxic substances. “This additional capacity, coupled with our international network, means Catalent can offer an unparalleled range and scale of services to the development and testing of large and small molecules,” says Graeme Lowe, director of analytical solutions for Catalent in Swindon. { For more information, visit catalent.com. DIA Booth No. 1539 Celerion and Ricerca Biosciences Form Biosimilars Alliance The Biosimilars Alliance formed by Celerion and Ricerca Biosciences is focused on preclinical and early clinical assessment of biologics manufactured by a new supplier. The Biosimilars Alliance offers all of the specialized services required to perform early assessment of the viability of a potential biosimilar product before beginning costly multicenter comparator studies in the target patient populations. “The announcement of The Biosimilars Alliance demonstrates Celerion’s ability to respond to client needs and offer effective solutions that leverage the knowledge base built up over the past 20 years of supporting biologic drug development,” says Susan Thornton, Ph.D., president and CEO at Celerion. { For more information, visit celerion.com. DIA Booth No. 1412 Chiltern Announces New Legal ­Entity In Taiwan Chiltern International has established a new legal entity in Taiwan. Dr. Umakanta Sahoo, Chiltern executive director, Asia Pacific and managing director, India, will be leading the effort. “Chiltern has already established a strong presence in this region with its offices in India, Singapore, and Australia and hence forming a legal entity in other important countries in the region is a natural progression to enhance our global reach,” he says. { For more information, visit chiltern.com. DIA Booth No. 3007 Invivodata Changes Organizational Structure to Meet Customer Needs Invivodata has made organizational changes to serve its biopharmaceutical and medical device clients. In response to regulators’ increasing emphasis on patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO), Invivodata is integrating its consulting division — formerly PRO Consulting —into its portfolio of Clinical Outcome Assessment (COA) consulting services. The new service will be called invivodata Consulting and will both complement and integrate with the e-solutions and regulatory services provided by invivodata. “Offering these scientific and regulatory services as a component of our broad COA data capture solutions delivers more value to our clients and allows us to respond to all of their needs,” says Doug Engfer, president and CEO of invivodata. { For more information, visit invivodata.com. DIA Booth No. 1416 PDR Leads EHR Initiative to ­Empower Drug Safety and ­Medication Adherence A coalition led by EHR vendors, PDR Network, professional liability carriers, and providers in collaboration with the FDA has developed a multifaceted initiative to improve drug safety and medication adherence by integrating drug services for prescribers and their patients into EHR platforms and other health information technology. PDR, along with RxEvent and CVS Caremark, has launched an adverse drug event reporting system, PDR Brief. The new service delivers full FDA-approved labeling and drug alerts within EHRs and e-prescribing systems. Other EHR vendors participating in the initiative and that are PDR-certified include Greenway Medical Technologies, Athenahealth, e-MDs, OfficeAlly, Connexin Software, First Medical Solutions, Universal E.H.R. Solutions, and OmniMD. { For more information, visit pdrnetwork.com. DIA Booth No. 2207 PharmaSeek Improves Site ­Operations PharmaSeek Financial Services has created Strategic Site Operations (SSO) to alleviate the pressure of administrative tasks by allowing research sites to focus on the clinical aspects of their business. The SSO team handles all back-end business operations, including pipeline management, budget and contract negotiation, regulatory, and accounts receivable assistance. The SSO team will run every clinical trial offered to a site regardless of the source. SSO also offers a la carte choices based on the site’s pain points. In other company news, PharmaSeek has introduced PatientWise Creative, a full-service patient recruitment and marketing firm for clinical trials focused on a common sense approach to optimize sponsor/CRO-allocated advertising dollars. PatientWise partners with research sites to optimize patient recruitment campaigns by blending traditional and non-traditional advertising. The company also specializes in customizing recruitment plans, negotiating recruitment budgets, and developing site-focused advertising campaigns. “More than ever, sites need assistance with patient recruitment,” says Annie Garvey, director of patient outreach, PharmaSeek. “If we can optimize the advertising dollars being allocated from the sponsor/CRO and generate more patients, then everyone wins.” { For more information, visit patientwise.com. DIA Booth No. 1524 Sentrx Introduces Patient Safety Nation Sentrx has introduced ­Patient Safety Nation, a pool of healthcare professionals dedicated to the safety of patients worldwide. Healthcare professionals can visit the Patient Safety Nation, provide professional information, and upload their resume, permitting a career match assessment. Sentrx informs candidates of positions that best match the applicant’s level of experience, areas of expertise, and professional credentials. “The marketplace has demanded that the assessment of adverse events be performed by healthcare professionals who fully understand the variety of factors involved with adverse event occurrences,” says Michael O’Gorman, CEO of Sentrx. “These professionals must work in harmony with pharmaceutical company counterparts. This means that companies need people who have significant experience in their drug’s therapeutic classification to effectively comply with the complex requirements of pharmacovigilance.” { For more information, visit sentrx.com. DIA Booth No. 1343

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