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DIA 45TH ANNUAL MEETING
We all share in the responsibility to work together to strengthen the science used in pharmaceutical product development, evaluation, and review,” says Program Chair Nancy Smith, Ph.D., former director of the Office of Training and Communications, CDER, at the U.S. Food and Drug Administration. “We must find new tools to detect safety issues from preclinical testing through postmarketing and to improve communi cations about the safe use of medicines to patients, physicians,and other interested parties.” This year’s meeting,which has the theme,“Better Medicines: Improving Safety with Every Step,” convenes more than8,900professionals,includ ing representatives from more than 50 countries. Additionally, the meeting features more than 1,100 speakers, including representatives from FDA, EMEA, and other global regulatory agencies. More than 800 exhibiting companies will showcase their products and services in the interactive exhibit hall. STRENGTHENING SCIENCE AND SAFETY Once again this year, the safety of medicines is top of mind at the Drug Information and Association’s 45th Annual Conference. Annual DIA Preview Showcase Feature PharmaVOICE is pleased to once again publish this Special Feature showcasing the new products, services, tools, and executive appointments and promotions from dozens of clinicalservices companies that will be exhibiting at the DIA 45th Annual Conference in San Diego, June 2125, 2009. For your convenience, we’ve divided the briefs into sections, including ESolutions, What’s New, and People. We also encourage you to log onto our digital edition at www.pharmavoice.com to view even more news and technologies from exhibiting companies. We look forward to seeing you in San Diego. Please stop by the PharmaVOICE booth — No. 1300 — to learn about what’s happening in the clinicalservices arena. Nancy Smith,Ph.D., former director of the Office of Training and Communications,CDER,at the U.S.Food and Drug Administration, is program chair for the Drug Information and Association’s 45th Annual Conference. Elsevier Partners with Communispace to Launch Global Online Community Elsevier, in partnership with Communispace, has launched Innovation Explorers, an online community of 300 researchers from 69 countries to help identify, design, and deliver relevant products and services that res onate with and inspire research scientists around the world. Communispace, which has created more than 325 online communities for the world’s largest brands, is actively lead ing member activity and the delivery of insights. “As a company, we’re com mitted to finding innovative ways to better involve our users and buyers in our business, while providing them with a global platform to engage with one another,” says Jay Katzen, managing director, academic and government products, at Elsevier. In other moves, Elsevier has acquired the assets of Professional Development Software (PDS), the provider of Softwarefornurses.com online learning education products. PDS has been integrated into Elsevier’s Evolve Testing and Remediation product suite, bringing additional content to Elsevier’s total curriculum solution for nursing. For more information, visit elsevier.com, or stop by Booth No. 529. WebBased i3Cube Simplifies ClinicalTrial Process i3’s recently launched i3Cube is a Webbased clinical trial and data management technology that leverages i3’s services and proprietary data to accelerate the clinical trial process through automation and connectivity, allowing customers to make more rapid, informed decisions about their products. i3Cube replaces the need for multiple systems and applications to manage study activities with an integrated solution that centralizes study infor mation into a single location throughout the entire clinical trial process. The solution features intuitive dash boards that deliver realtime reporting and access to study information to sponsors and investigative site staff. Additionally, i3Cube provides greater speed and efficiencies through streamlined communication across the entire study team, studyspecific automated workflow, and an integrated study library with version control, including an electronic trial master file. “We brought together our use of proprietary healthcare claims data with our clinical research expertise and developed i3Cube to create time and cost efficiencies for our customers,” says Glenn Bilawsky, CEO of i3. For more information, visit i3global.com, or stop by Booth No. 107. Medidata Rave Monitor Helps Manage Site Visits Rave Monitor is an extension of Medidata Solutions’ Medidata Rave EDC and CDM solution that offers research sponsors and CROs a more efficient, compliant, and costeffective way to manage site visits. Sitemonitoring activities represent one of the largest cost drivers in clinical research today, increasing the importance of improving the efficiency and effectiveness with which monitors or CRAs perform tasks. The addition of Rave Monitor further extends the set of capabilities available to CRAs ESOLUTIONS The following briefs include information about new ebased clinically related solutions. The companies in this section are presented in alphabetical order. Our goal for Innovation Explorers is to discover, in partnership with the researchers themselves, how Elsevier can help improve their research outcomes, says Jay Katzen of Elsevier. i3Cube was designed to provide our clients and clinical investigators with a simple, easytouse, and streamlined experience, says Glenn Bilawsky of i3. The introduction of Rave Monitor enables us to provide research sponsors and CROs with even more ways to work effectively with their sites, says Medidata’s Glen de Vries. To access a Free Demo featuring i3Cube, go to i3global.com/solutions/i3Cube. by providing a new tool that makes a key part of their job —- reporting onsite visits —- more efficient. “Medidata is committed to enhancing our customers’ competitive advantage by providing the tools and services that enable operational excellence across their entire clinical development team,” says President Glen de Vries. Rave Monitor enhances crossstudy operational visibility for study managers by providing users with online and offline visit report capture, approval work flow, and interstudy and crossstudy status reporting, all within the context of their existing Rave deployment. For more information, visit mdsol.com, or stop by Booth No. 701. Nextrials Expands Prism’s Report Generation Functionality Nextrials has increased the report generation functionality of its Prism data capture and clinical trial management platform to deliver more powerful data mining capabilities to customers. With its improved ad hoc reporting feature, Prism users can now collect, summarize, and export data from tables within a single study or across multiple studies, creating efficiencies that save time and lower study costs. Its userfriendly graphical interface also includes advanced interactive data view formats, such as heat maps, in addition to bar graphs, pie charts, and other standard visual templates. “Prism’s enhanced reporting capabilities make it easier to both compile trial data and drill down on data points of interest, providing better visibility of study results and reducing the opportunity for error,” notes Chief Technology Officer Robert Barr. For more information, visit nextrials.com, or stop by Booth No. 1302. Octagon Research Links Content Management Systems Octagon Research Solutions’ ViewPoint Connector provides a way to link multiple data repositories either as a module to Octagon’s ownViewPoint process management solution or as standalone software that links to popular content management systems from companies such as Oracle and Microsoft. ViewPoint Connector’s document and data integra tion features facilitate twoway communication with content management repositories, respect security defined within the content management system, and provide a fundamental building block for applications that are integrating with content management systems. Octagon’s ViewPoint solution uses the optional Connector module to access content management systems while managing and controlling content driven enterprise processes such as global regulatory submissions. “The ViewPoint Connector module goes beyond existing technologies on the market by enabling a higher degree of integration and supporting routinely requested actions between applications,” says Aaron Miller, chief technology officer. For more information, visit octagonresearch.com, or stop by Booth No. 513. SAS Launches Physician Targeting Solution SAS’ recently introduced physician targeting solution helps organizations apply predictive analytics to sales, CRM, and other customer data to go beyond deciling and target physicians based on profitability, retention, and future probability to prescribe. Using a broad range of predictive modeling techniques, SAS for Physician Targeting enables organizations to under stand the rules and characteristics surrounding why physicians have prescribed in the past and apply those rules to predict who will be the prescribers of the future. Analytics can glean high value targets from previously nontarget populations. “The SAS solution can mine prescription data with other data points, such as CRM data, managed care, health plan, and patientlevel data to predict which physicians are responsible for the prescribing activity and segment accordingly,” says Jason Burke, global director of health and life sciences. For more information, visit sas.com, or stop by Booth No. 301. Thomson Reuters Adds to Liquent, IDRAC Product Lines The healthcare and science business of Thomson Reuters has unveiled a number of additions and upgrades to its family of Liquent solutions. The recently introduced Liquent PublishPerfect is an enterprise publishing product that enables the efficient, integrated, and compliant publishing of reports from compilation to approval. “In a market where time is of the essence, Liquent Publish Perfect allows users to remain in one program instead of going between several,” says Jeff Huntsman, VP, global sales, ser vices and software solutions at Thomson Reuters. Liquent PublishPerfect equips each unique document management system to create PDF documents that are fully compliant with the specifica tions of the regulatory authorities. Other features of the solution include a separate standalone publishing process outside of submission publishing; an entirely Webbased solution requiring no software instal lation; compliant outputs; and the capability to provide additional information publishing such as watermarks, overlays, and bookmarks. Thomson Reuters also has launched Liquent InSight Publisher Select, a new tool that enables small and emerging lifesciences companies to quickly create, review, amend, and submit regulatory dossiers. “We are confident that Publisher Select will empower smaller and startup lifesciences compa nies by streamlining their filing processes, thereby reducing their time to market,” says Jim Nichols, VP, Liquent software. In other moves, Thomson Reuters has issued an upgrade to Liquent InSight Manager that offers more flexibility and usability for daytoday processes, such as regulatory submissions. Users can now plan and track submission activity in alignment with their own regulatory strategy with the Global Project Planning (GPP) wizard, which greatly reduces the data entry needed for the submission process. Thomson Reuters also has launched IDRAC Notes, an addon commenting feature that allows IDRAC to create, update, and share comments attached to IDRAC PDF documents. For more information, visit thomsonreuters.com, or stop by Booth No. 821. ToaccessaFreeDemo featuring ViewPointConnector, go to octagonresearch.com/viewpointconnector.html It’s important for researchers to be able to generate reports customized for numerous audiences, ranging from safety analysts to clinicians, says Robert Barr. ViewPoint Connector enables the integration of content from disparate repositories into standardized processes, says Octagon’s Aaron Miller. As more pharma organizations restructure their approach to sales, the need for enhanced targeting tools increases, says Jason Burke of SAS. The resulting reports are generated to the PDF specification as required by regulatory authorities, saving time and money, says Jeff Huntsman of Thomson Reuters. To help our customers best apply Liquent InSight Publisher Select to their filing needs, we are offering Publisher Select customers product training at no additional cost, says Liquent’s Jim Nichols. Almac and PHT TeamU p to Improve Clinical Trial Productivity Almac Clinical Technologies and PHT have forged an alliance to improve clinicaltrial productivity through a variety of education initiatives and data integration efforts that will reduce clinical trial site burdens while improving study data collection and reporting. PHT and Almac have agreed to provide consultation with clinical trial sponsors on the difficult question of choosing the appro priate technology for studies involving electronic patient reported outcomes (ePROs). The first joint data initiative involves integration of Almac’s patient screening and randomization data with PHT’s handheld devices for ePRO studies. “Our customers are constantly looking for ways to integrate multiple streams of eclinical data and reduce the data entry burden on sites,” says PHT CEO Philip Lee. “Our partnership with Almac offers added value for both sponsors and sites with one less data source to reconcile and the removal of a manual data entry step.” For more information about Almac Clinical Technologies, visit almacgroup.com, or stop by Booth No. 1301. For more information about PHT, visit phtcorp.com, or stop by Booth No. 1124 and 1125. BBK Establishes Osaka Location BBK Worldwide has opened BBKWorldwide — Osaka, which is committed to supporting Japanese pharmaceutical, biotech, and medicaldevice companies, as well as CROs and SMOs, to more rapidly and effectively enroll and retain patients as participants in clinical studies. “Osaka seemed the ideal place to establish the opera tional base for our building of bridges — between recruitment barriers and enrollment solutions, and between cultures and business practices,” says Jeremy Buchman, who heads up the Osaka office. For more information, visit bbkworldwide.com, or stop by Booth No. 1221. Charles River Acquires Piedmont Research Center Charles River Laboratories International has agreed to acquire the business and assets of Piedmont Research Center (PRC), a wholly owned subsidiary of PPD, for $46 million in cash, significantly expanding the oncology expertise offered through Charles River’s discovery and imaging services. PRC provides preclinical discovery services focused on efficacy studies in oncology and other therapeutic areas for pharmaceutical and biotechnol ogy clients, as well as nonGLP (good laboratory practice) pre clinical efficacy testing services with expertise in the key thera peutic area of oncology. The company also offers a range of other in vivo, in vitro, and analytical services to supplement its core phar macology offering. PRC continues to operate from its North Carolina headquarters as part of Charles River’s Discovery and Imaging Services business. “The addition of PRC’s expertise, particularly in oncology, expands Charles River Discovery and Imag ing Services’ portfolio of efficacy testing services to better support our clients’ needs,” says James Foster, chairman, president, and CEO of Charles River. For more information, visit criver.com, or stop by Booth No. 1731. Chiltern Acquires BrazilBased CROVigiun Chiltern International has acquired Vigiun, a full service CRO located in Sao Paulo, Brazil. Vigiun has experience conducting clinical trials in a variety of therapeutic areas, in particular, infectious disease, oncology, and respiratory. The acquisition of Vigiun enhances Chiltern’s growing presence in Latin America, which was estab lished a year ago when the company began operations in Argentina under the leadership of Oscar Podesta, general manager for Latin America. Two Vigiun staff have assumed new roles at Chiltern. Dr. Eduardo Forleo has been appointed country manager for Brazil, and Elisa Halker serves as director of clinical operations for Brazil. For more information, visit chiltern.com, or stop by Booth No. 203. ERT Launches New Identity, Website ERT, the new identity launched by the former eResearchTechnology, reflects the company’s proactive organi zation that is committed to redefining and setting new stan dards of how clinical trials are successfully conducted. ERT’s brand strategy brings an enhanced visual identity to market as well as sharpened product positioning, a new Web site, messaging, and corporate collateral. The ERT Website pro vides an enhanced online experience detailing infor mation on ERT’s portfolio of clinicaltrial solutions as well as all company news and events, which serve to educate customers and facilitate inquiries. As part of its new branding, ERT has introduced a new global platform of products and services that con sists of four subbrands: Cardiac Safety Solutions; EDC Solutions; ePRO Solutions; and ERT Clinical Research Consulting Group. “Our new brand identity reflects ERT’s dynamism and passion while continuing to instill the confidence and trust that the industry has in our products and ser vices,” says Michael McKelvey, president and CEO of ERT. For more information, visit ert.com, or stop by Booth No. 507. Icon,MedAvante Forge CNS Partnership Icon and MedAvante have entered an alliance that aims to enhance precision and reduce highfailure rates in CNS trials. “MedAvante has developed a platform that addresses a major cause of clinicaltrial fail ure in CNS development: vari ability in both clinical diagnosis of the disorder being studied and ongoing assessment of the severity of the patient’s symp toms in a consistent and stan dardized fashion,” says John Hubbard, Ph.D., president, Icon Clinical Research. “This alliance extends our ability to offer our ser vices across the industry and across the globe,” adds Paul Gilbert, CEO of MedAvante. “Most importantly, however, is what this alliance provides to CNS drug WHAT’S NEW The following briefs include company news about new clinically related operations. The companies in this section are presented in alphabetical order. Together, PHT and Almac are helping sponsors and sites remove time consuming data cleaning tasks to focus on what they care about most: the health and safety of patients and conducting rigorous scientific research, says PHT’s Philip Lee. Osaka is an optimal location from which to operationalize our patient recruitment efforts on behalf of our clients throughout the AsiaPacific region, says BBK’s Jeremy Buchman. As pharmaceutical and biotechnology companies increasingly choose strategic outsourcing as the means to accelerate their drugdevelopment efforts, they need to rely on their service partners to provide scientific depth and expertise in therapeutic areas, says James Foster of Charles River. We see the change as a move forward in establishing the company as a reliable partner in products and services for clinical trials, says ERT’s Michael McKelvey. Icon is constantly striving to offer our pharmaceutical and biotechnology partners innovative clinicaltrial solutions to enhance the drugdevelopment process, says Icon’s John Hubbard. developers, the ability on a larger scale to reduce the high rate of failed CNS clinical trials, which the indus try recognizes as unacceptable in terms of cost and lost time.” For more information about Icon, visit iconclini cal.com, or stop by Booth No. 1307. For more information about MedAvante, visit medavante.net, or stop by Booth No. 1822. Lionbridge,OpenText Join Forces to Streamline Regulatory Compliance Solutions Lionbridge Technologies and Open Text have entered an alliance designed to ensure effi cient, reliable integration of reg ulatory compliance and docu ment management solutions for pharmaceutical companies and other organizations. “By delivering a complete solution, we are helping our cus tomers increase their process efficiency, improve productivity, and address compliance requirements while reaching new global markets,” says Satish Maripuri, chief operating officer of Lionbridge. For more information about Lionbridge, visit lionbridge.com, or stop by Booth No. 730. For more information about Open Text, visit opentext.com, or stop by Booth No. 2024. PharmaNet Establishes Clinical HRBusiness PharmaNet Development Group has established PharmaNet Resource Solutions, a new clinical develop ment human resourcing business that offers extensive industry experience in both clinical operations and con tract staffing management. PharmaNet Resource Solu tions provides several contract resourcing services, including ondemand staffing, strategic alliances, func tional service staffing, and quality control services. “We offer a strong management team and experi enced clinical research professionals who provide clients practical, customized resource strategies to ensure their requirements are delivered on time and with the appropriate level of experience,” says Susan Seroskie, R.N., who heads the unit as VP, PharmaNet Resource Solutions. Ms. Seroskie joins PharmaNet from The Clinical Resource Network, where she served as senior VP, managed services. In other expansion moves, PharmaNet has opened a new office in Sao Paulo, Brazil, to further enhance its Latin American presence. The company has been pro viding clinicaltrial support in Latin America since 2002. For more information, visit pharmanet.com, or stop by Booth No. 320 and 321. Premier Research Expands Medical Device Operations to United States Premier Research Group has expanded its medicaldevice operations to include full cover age in the United States. The company’s medical device group has been offering clinicaltrial services in Europe since 1997. “Providing U.S. and EU ser vices is a strategic focus for our company, and this strengthens our ability to respond to cus tomers’ needs,” says Premier Research Chief Operating Officer Troy McCall, Ph.D. Premier’s U.S. medicaldevice operations are over seen by Efraim Roe Kozorovitsky, executive director, medical devices. For more information, visit premierresearch.com, or stop by Booth No. 827. Quintiles’Argentina Facility Earns CAPAccreditation Quintiles Transnational’s central laboratory in Buenos Aires, Argentina, was recently accredited by the College of American Pathologists (CAP), giving Quintiles the largest CAP accredited central laboratory network in the world and setting a standard for patient safety and faster drug development. All nine Quintiles central labs are now CAPaccredited, includ ing wholly owned facilities in China, India, Singapore, Scot land, South Africa, and the United States; and subcontractor labs in Argentina, Brazil, and Japan. “We offer a combination of global resources, stateofthe art buildings and equipment, staff experience and expertise, and highquality and accurate service,” says Tom Wollman, senior VP, Quintiles Global Cen tral Laboratories. For more information, visit quintiles.com, or stop by Booth No. 329. Radiant Research Partners with IndiaBased Spectrum Clinical Research Radiant Research has established a strategic part nership with Indiabased Spectrum Clinical Research, allowing Radiant to provide CRO and site services across both North America and India. Both Radiant and Spectrum share expertise in a wide range of therapeutic areas, as well as a proactive recruitment approach to trials, using health screening campaigns to build databases in anticipation of enroll ment. For more information, visit radiantresearch.com, or stop by Booth No. 1904. Smith Hanley Consulting Establishes Business Intelligence and Analytics Practice Smith Hanley Consulting Group (SHCG), an inVentiv Health company, has launched a strategic business intelligence, data warehousing, and analytics practice as a complement to its staffing organization. The new practice assists SHCG clients in improving factbased decisionmaking in their operations, financial manage ment, and regulatory compliance areas. As part of the launch, SHCG has appointed Bharat Chitnavis as director, business intelligence and analyt ics, with responsibility for leading the practice. Mr. Chitnavis reports to Managing Director Shelley Muhs, who has overall accountabilities of SHCG with the expanded business. For more information, visit smithhanleyconsult ing.com, or stop by Booth No. 722. WCC Service Supports EarlyStage Clinical Studies WorldCare Clinical (WCC) is now offering a new service, Collect, Ready, Hold, which supports sponsors conducting earlystage and Phase II clinical trials. The service helps to save time and money by allowing imaging data to be collected and standardized accord ing to the imaging protocol, then held in a single, secure database until a central review of the data is requested. Collect, Ready, Hold builds upon the company’s extensive operational and regulatory expertise and employs WCC’s WorldPro image management technol ogy to acquire and prepare imaging data and store it all in a single, secure database. This gives sponsors com plete control of the images acquired and helps them respond to the FDA or other regulatory agencies, streamlining review processes if needed. “Sponsors conducting Phase II trials many times either don’t have the funding in place or have yet to receive a request from the FDA to conduct a central review of their imaging data,” says Richard Walovitch, WCC’s chief medical officer. “Collect, Ready, Hold was developed in response to these challenges as a cost effective and preemptive approach for sponsors to col lect, QC, and store images in a central database until it is determined if a central review of the imaging data is required.” For more information, visit wcclinical.com, or stop by Booth No. 1501. Together, Lionbridge and Open Text provide our customers life sciences regulatory expertise and reliable content management solutions, says Lionbridge’s Satish Maripuri. Our clients have requested expanded medicaldevice services, and we are committed to responding to these needs, says Dr.Troy McCall of Premier Research. CAP accreditation validates the highquality central lab services we offer at each of our sites around the world, says Quintiles’ Marina Travacio. As the pharma industry adapts to a changing environment, Quintiles is well positioned to remain the provider of choice for laboratory services, says Tom Wollman of Quintiles. Chiltern is an equal opportunity employer and we ensure that we give full consideration to individual needs for work life balance , personal fulfillment and growth . We are constantly looking for talented individuals at all levels of experience. 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