Tools of the Trade

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Carolyn Gretton

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

Featured Briefs:

OpenQ SafeGuard Manages Social Enterprise Compliance Risk System Aims to Reduce ­Research Cycle Times In other technology news… E-UPGRADES AND ENHANCEMENTS Site Offers New Way for Life-Sciences Firms to Find Partners Journal Site Customized for ­Internal Medicine Specialists Tools of the Trade OpenQ SafeGuard is a social enterprise compliance suite that allows companies with social compliance risk to deliver accurate and complete archiving, proactive analysis, real-time review auditing, and remediation. SafeGuard collects and consolidates activity feeds, posts, and documents from social platforms and other collaboration tools to identify and classify business and compliance risk. An intuitive interface enables the efficient management of compliance cases with classification of risk level according to industry- and company-defined priorities. “Social platforms are revolutionizing business by improving a company’s ability to collaborate internally and with customers, reduce costs, and improve a product’s competitive advantage,” notes OpenQ President Jim Zuffoletti. “However, many companies have been slow to go ‘social’ for fear of leaking trade secrets, incurring liabilities, or committing compliance violations.” “SafeGuard enables faster enterprise adoption of social collaboration and allows companies to benefit from the value created by new social technologies,” adds Otavio Freire, chief technology officer. “It also allows you to create social policies for specific channels and enforce the policies guaranteeing that they stand up to internal audit processes.” { For more information, visit openq.com. Trend: Social-media compliance technologies enable companies to embrace new media tools while ­ maintaining regulatory compliance, privacy, internal communication firewalls, and brand consistency. System Aims to Reduce ­Research Cycle Times iGate has unveiled the iGate Research AcceleratoR platform for Life Sciences, a streamlined program designed to reduce the cycle times and costs of bringing a new drug or medical device to market. The Research Accelerator empowers pharmaceutical developers and CROs with fully integrated clinical information management technology and iGate’s business outcomes-based methodology, enabling them to make better, faster, more informed decisions throughout the drug development process. Drug developers that engage in a business outcomes approach pay only for performance, unlike the time and material billing other vendors use, leading to increased project hours and, ultimately, higher billing. David Kruzner, executive VP, iTops Solutions and Consulting, with iGate, observes that with today’s pressures on life-sciences companies to bring compounds to market quickly and effectively, the slightest inefficiencies can put millions of dollars at risk. “Utilizing the Research Accelerator platform, organizations can do a far better job of capturing critical data across multiple systems and verifying, analyzing, reporting, and reusing it through multiple phases, supporting their short- and long-term objectives,” Mr. Kruzner says. { For more information, visit igate.com. In other technology news… Forte Research Systems has partnered with a commercial bank to create the Allegro ePayments system for research sites that reimburse clinical research patient volunteers for their contribution to scientific discovery. Allegro helps eliminate time and costs associated with issuing checks or tracking cash payments to patients who participate in clinical research studies. Cardholders receive a personalized, prepaid debit card in the mail soon after their initial session, and payments are loaded directly to the patient’s card, eliminating wait time for a check in the mail. Through Allegro, payments are automatically reconciled within the financial management functionality of their clinical trial management system. “Our customers were struggling with the fact that they were losing time and money on the patient reimbursement process,” says Srini Kalluri, CEO and chief customer officer at Forte Research Systems. { For more information, visit forteresearch.com. OmniComm Systems’ new level of integration with PharmaPros provides OmniComm customers with a solution offering next-generation clinical trial management system (CTMS) capabilities for midsized organizations interested in a flexible software solution for clinical trials management. The partnership enables OmniComm customers to add Dataflow Manager to their TrialMaster solution on an as-needed or per-trial basis. The integrated solution provides capabilities for site management and monitoring, budget tracking and management, eTMF/document tracking, metrics portal, and real-time reporting. “We are extremely pleased that OmniComm is now bundling Dataflow Manager’s unique study management capabilities with their TrialMaster EDC product,” says Brion Regan, head of strategic development for PharmaPros. “We are excited about this new partnership and the benefits this marriage of EDC and CTMS will provide to our customers,” adds Stephen Johnson, president and chief operating officer of OmniComm. { For more information, visit omnicomm.com. Parexel International has launched Parexel MyTrials, a fully integrated e-clinical platform that simplifies the clinical trial process by providing comprehensive support for the drug development process. While current technology has promised to accelerate the design and execution of clinical trials, the increased adoption of individual applications creates new integration challenges and workflow inefficiencies. Developed by Parexel’s technology subsidiary Perceptive Informatics, Parexel MyTrials addresses these inefficiencies by providing a unified framework that includes benefits such as single sign-on; seamless movement between applications; and a single, secure repository for all of the necessary study information, documentation, and training resources, as well as sponsor level libraries, study calendars, training records, and discussion forums. “In recent years there has been an increase in the number of applications for managing the clinical trials process, but these independent systems are not necessarily compatible with each other: for example, forcing users to enter the same data multiple times in different applications,” notes Mark Goldberg, M.D., chief operating officer, Parexel. { For more information, visit parexel.com. IMS Siteoptimizer is a cloud-based solution that enables clinical trial organizations to more effectively identify and assess trial site locations and recruit best-performing investigators. The offering leverages IMS Health’s DecisionView technology platform to capture and analyze enrollment performance for clinical trial investigative sites and investigators. With this insight, study teams can build optimized site rosters based on real-world performance, identifying sites and selecting investigators based on their experience with an indication, geographic location, and available capacity. “When integrated with our StudyOptimizer solution, SiteOptimizer offers bottom-up, site-level enrollment planning and more granular enrollment optimization,” says Linda Drumright, general manager, IMS Health. { For more information, visit imshealth.com. Marketing consultancy RMi has introduced Intelliscore, a proprietary engagement quotient that provides clients both a real-time snapshot of how physicians are engaging with their marketing efforts, and an assessment of the quality of that engagement. The first in a suite of proprietary RMi methodologies called SyntheSight, the IntelliScore scoring algorithm tracks physicians’ receptivity to and engagement with marketing methods and brand messages across a variety of channels, which can include email, direct mail, surveys, sales calls, and speaker events. Scott Clair, Ph.D., RMi director of market insights and analytics, says by combining both the attitudinal and behavioral insights IntelliScore provides through its ‘intensity’ scoring index, analysts can forecast future physician prescribing behavior with a great degree of accuracy. “IntelliScore gives us the data we need to help brand managers refine their marketing campaigns immediately to enhance response,” Dr. Clair says. { For more information, visit rmarketing.com. R&D software and services company Accelrys has released Accelrys Discovery Studio 3.5 modeling and simulation software. The latest release extends Discovery Studio’s portfolio of small-molecule ligand design and biological simulation tools, ­including a new, validated ligand-profiling database for drug repurposing studies, new science to assess the development potential of putative biologics and many additional ­enhancements that help deliver a highly ­effective life-sciences modeling and simulation environment. { For more information, visit accelrys.com. Nextrials has made available an Apple iPad ­application for its Prism clinical trial management platform, allowing pharmaceutical and biotech researchers to receive access to key data points, reports, and statistics about ongoing ­studies, ­regardless of location. The application ­enables ­researchers to view real-time data related to ­patient recruitment/enrollment status, ­demographics, queries, and monitoring through Prism’s custom-built iPad interface. { For more information, visit nextrials.com. Octagon Research Solutions has added new functionality to its Quantum RIM and Starting Point solutions. Quantum RIM now includes a preconfigured eTMF solution that applies the DIA TMF reference model within the Quantum Content Manager environment to optimize real-time management and tracking of trial-related content. The latest release of Octagon’s StartingPoint global submission document authoring solution now includes an expanded range of content templates and new capabilities supporting document creation and validation. The updated version adds greater speed and efficiency to the authoring, review, and publishing of submission documents. { For more information, visit octagon.com. use your QR?CODE?READER or go to bit.ly/PV0912-Tools Biocom’s new website, biocomcro.org, provides the regional life-sciences association’s members with information on the wide range of services offered by the contract research organization (CRO) community in southern California. Via biocomcro.org, Biocom members can access a comprehensive CRO company directory and easily search for a CRO service provider based upon specific criteria. The website also features a drug development guide that provides a detailed description of each phase of development and includes a list of CRO members that understand the key disease areas members are working on and can assist in bringing safe and effective new treatments to patients. A resource section will also be available for companies to access best practices, FAQs, and presentations from Biocom’s educational event series. “Over the last few years, the southern California CRO cluster has proven itself to be unrivaled anywhere in the United States,” observes Joe Panetta, president and CEO of Biocom. “CROs have increasingly become invaluable partners for our life-sciences companies by providing critical expertise essential to accelerating drug development.” { For more information, visit biocomcro.org. Journal Site Customized for ­Internal Medicine Specialists Annals of Internal Medicine, the flagship journal of the American College of Physicians (ACP), is launching its website on a digital platform to provide internal medicine specialists and subspecialists with a more personalized Web experience. Annals.org offers an improved search function across the Annals journal, ACP Journal Club, In the Clinic, PubMed, and a new multimedia library. The site delivers faster, targeted search results that incorporate individual preferences. “The new design, information architecture, and site navigation are intended to make the user experience more efficient, effective, and engaging for busy internists,” says Christine Laine, M.D., Annals’ editor-in-chief and senior vice president at ACP. { For more information, visit annals.org. In other technology news… BBK Worldwide has launched shop.BBKWorldwide.com, an online resource where clinical research professionals can learn about and purchase a full range of patient recruitment products and services. The website redefines the audience of purchasers to include those looking for stand-alone solutions. Clinical trial sponsors who previously may not have considered purchasing patient recruitment services now have an affordable and scalable way to do so. In addition, the site features a range of recent innovations that include a card to provide global study reimbursements, a notification service that alerts patients to clinical trials, and an iPad-based communications platform. “In an industry driven by the pressure to reduce time to market, traditional strategies have focused on accelerating the enrollment of patients,” says Bonnie Brescia, founding principal, BBK Worldwide. “With more complex clinical trials comes the demand for more advanced tools,” says Joan Bachenheimer, founding principal and CEO, BBK Worldwide. { For more information, visit shop.bbkworldwide.com. Quintiles Infosario Systems as a Service Lifecycyle Safety System provides an integrated, fully functional environment to support all aspects of the pharmacovigilance process. Benefits provided by the holistic, cloud-based solution include reduced IT costs; improved, higher-quality pharmacovigilance; best-in-class workflow and operational metrics; and highly scalable, rapid deployment. { For more information, visit quintiles.com. Pharmaceutical Regulatory Services (PRS) has launched GRID (Global REgulatory Intelligence Database), an online database of pre- and postapproval pharmacovigilance requirements for drugs and biologics in more than 75 countries. The database is available on a cloud technology platform and includes information in an easy-to-find grid format with hyperlinks to the most current reference documents. While the database is maintained by PRS, clients have the capability to include their own comments in a client-specific comment section. { For more information, visit pharmregservices.com. Decision Resources Group has unveiled PharmaVIEW, an interactive online tool providing transparent forecasts and assumptions on more than 1,500 drugs and more than 150 disease indications, including more than 900 patient populations across the G7 pharmaceutical markets (the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan). The PharmaView platform enables users to benchmark internal forecasts and track growth; analyze the sales potential of a candidate by drug, brand, or company, including five years of historical sales and market share data; and assess barriers to entry and the impact of key therapeutic events. { For more information, visit drgprofessionalservices.com. Reprints Desk, a Derycz Scientific company, has launched hcpengage.com, a content-enriched website sponsored by Reprints Desk and ExL Pharma that features video interviews with healthcare professionals and industry thought leaders. The website was created to further the dialogue related to the peer-reviewed science and interactions between healthcare professionals, patients, sales reps, and life-sciences companies. { For more information, visit hcpengage.com.

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