NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES eDrugSearch has unveiled the eDrugSearch.com Community, a social network for Americans seeking safe, lowcost prescrip tion medications online. The Health 2.0 community comple ments eDrugSearch’s specialized search engine for prescrip tiondrug consumers in the United States who are looking for medications from pre screened international pharma cies. “U.S. consumers who want access to prescription drugs at fair, affordable prices have long had the odds stacked against them,” says Cary Byrd, presi dent and founder of eDrugSearch.com. “We started eDrugSearch.com to level the playing field, giving consumers a safe way to find lowcost prescription drugs online from Canadian and other nonU.S. pharmacies. Now, by creating the edrugsearch.com Community, we are moving beyond specialized search to enable our members to share information about their experi ences, both with online prescriptions and online pharmacies.” By participating in the edrugsearch.com Community, mem bers earn points redeemable for drug discounts at participating pharmacies. Members of the edrugsearch.com Community can rate and contribute candid reviews of participating phar macies, providing firsthand accounts of their experiences,and can also share their experiences with specific medi cations, as well as exchange informa tion on efficacy, side effects, and value. Through the community, members can ask and answer questions and add to their knowledge of specific conditions and medications by forming interest groups and adding friends. In addition, the community allows members to monitor the latest news,member comments,and price changes for the medications they take regularly. eDrugSearch Launches SOCIAL NETWORK FOR PRESCRIPTION DRUGCONSUMERS Exco InTouch Creates Solution to Improve STUDY RECRUITMENT,RETENTION Exco InTouch has introduced React, a secure mobile communications solution designed to improve recruitment,retention,and compliance dur ing clinical trials and pharmaceutical marketing studies. Finding good quality volunteers and patients for clinical trials is a continuing challenge. Short mes sage service (SMS) helps target, identify, and locate volunteers and patient populations and provides a new channel to deliver timed reminders regarding screening appointments and trial prerequisites. React employs SMS to deliver scheduled, action driven text messages directly to the mobile phone user, enhancing volunteer relationship management and improving patient retention and compliance. The content of these messages can range from deliv ering reminder services to patients to nonintrusive methods of promoting investigator relationships.Par ticipants and investigators can be linked, providing seamless, traceable communication paths. React allows for the customization of mobile ser vices and can be integrated into existing systems or delivered as a custommade application. The soft ware also enables a selection of messages from approved,validated, local language translations, with the capacity to insert multiple variables for personal ized messages. React is available as a hosted service or as an enterprise solution installed within a corporate net work,allowing rapid import of contact management data. It integrates seamlessly with both electronic and paperbased clinicaltrial workflow processes through a secure encryption of mobile user data. Seamless integration with email and total reporting facilities is also available, allowing for full role and rightsbased access. Health 2.0 is all about empowerment and making more informed decisions, says Cary Byrd, President and Founder of eDrugSearch.com. Brand BodyGuard Combats INACCURATEWEB INFO Compass Healthcare Communications has launched a reputation man agement program, Brand BodyGuard, to protect pharmaceutical brands from negative or inaccurate information that shows up in search engine results. In this age of usergenerated content, anyone with an Internet con nection and a blog account can create a negative post about a pharma ceutical brand. Websites and discussion boards also can generate negative or inac curate information about a product. When people search for a brand name or a relevant term, search engine results often include this negative press. Using Brand BodyGuard, reputation management experts at Compass monitor the blogs, discussion boards, and Websites that discuss the brand or health topics relevant to the brand.They defend the brand against neg ative press by creating positive content that edges out negative content in search engine results. Compass works with reputable Websites to place the content, provid ing customized brand and disease information and press releases,along with references,appropriate links,and other support needed by publishers and Webmasters. “A brand name is a valuable investment,”says Eileen O’Brien, M.S., director of online promotions at Com pass. Services provided by Brand BodyGuard include keyword research, press release development and opti mization, linking, online outreach and content syndication, monitoring of online discussion, and domain pur chasing and registration. The program measures results by capturing data on: the suppression of negative brand mentions on the search engine results pages,optimum search engine results pages for brandrelated queries,and qualified traf fic driven to the brand’s Website. Brand BodyGuard ensures that a brand is accurately and appropriately represented online, and that the messages that reach target audiences are the ones that pharmaceutical brand managers want them to see,Ms. O’Brien adds. Using Brand BodyGuard, Compass’reputation management experts monitor the blogs,discussion boards,and Websites that discuss the brand or health topics relevant to the brand. 98 M a y 20 08 PharmaVOICE PV0508 Issue FINAL2 4/23/08 10:39 AM Page 98 Emedia # Aris Global,Orlando Fla., has released 2.0 versions of agClinical andagClinical NW, its comprehensive solutions that track processes supporting clinical trial activities in accordance with ICHGCP standards. AgClinical,designed for the smaller lifesciences company, provides core trial management functionality and offers easy integration with multiple clinical applications,while agClinical NW helps large companies perform and manage endtoend clinical trial processes more effectively and efficiently than other available clinical trials management system (CTMS) offerings.Both agClinical and agClinical NW offer a centralized platform for integrating,executing,and managing the range of global clinical research programs. SAP has made a minority investment in Aris Global through its global SAP NetWeaver Fund,which underscores SAP’s commitment to fuel the development of innovative solutions built on the SAP NetWeaver platform.SAP and Aris Global have cooperated through the fund in the coinnovation of agClinical NW. For more information, visit arisglobal.com. # Oracle Remote Data Capture Onsite 4.5.3 is the newest version of Oracle’s electronic data capture (EDC) solution designed to help lifesciences organizations and contract research organizations (CROs) conduct clinical trials and studies more effectively and efficiently.The new version is completely Webbased,with zero client footprint for the HTML data entry window to enable improved global access and performance. It also is integrated with the Oracle Clinical data management system and is an integral component of Oracle’s extensive suite of clinical trial management applications. Enhancements featured in Oracle Remote Data Capture Onsite 4.5.3 include rapid navigation to patient case report forms,a new patient data report file that offers significant performance gains and is better tailored for use in electronic submissions,and a robust system of edit checks to help ensure data accuracy and integrity. For more information, visit oracle.com. # Phoenix Data Systems,a provider of electronic data capture (EDC) and clinical data management solutions based in King of Prussia, Pa., has introduced a version of its PDS Express EDC software for global clinical trials with enhanced submissionsready data capabilities. With PDS Express Version 4.1 users can provide multiple types of studydefinable marking abilities and customize and retain these preferences.Other improvements include enhanced support for multiple studies,customizable EUPGRADES AND ENHANCEMENTS formatting and data filters, and new dataentry features such as autocomplete and singleclick data clearance. In addition,clinical trials conducted using Version 4.1 are supported with the PDS IPP Generator.This capability produces individual patient profiles in PDF format fully compliant with FDA electronic submission guidelines for all data contained in the PDS Express database. For more information, visit phoenixdatasystems.net. # Protocol Feasibility Assessment, the newest iTrials tool from Provisio, helps biotech,pharmaceutical,and medical device companies to accurately gauge the degree of a trial’s success before enrolling the trial. Provisio, Nashville,Tenn., develops technologies and services that enhance clinicaltrial processes. Its flagship solution, iTrials, automates and streamlines the way drug trial candidates are identified, notified, and enrolled. Provisio’s iTrials Data Universe is populated from more than 500,000 physicians with unique diagnoses and treatment histories for more than 60 million patients. The Protocol Feasibility Assessment service leverages the iTrials Data Universe to develop a crossreferenced impact analysis that determines how each inclusion/exclusion criterion expands or shrinks the candidate pool. It then identifies clusters of eligible candidates by geographic regions,media markets,metro areas,and other criteria; suggests locations for potential study sites based on proximity to prequalified patient clusters; and assesses recruitment timelines and enrollment probabilities based on a number of variables. For more information, visit itrials.com. # ThomsonHealthcare,Stamford,Conn.,has introduced the next generation of its healthcare decision support tool, MedstatAdvantageSuite4.0,which features service oriented architecture,an application portal, improved production reporting,and a dashboard reporting feature. Advantage Suite enables large employers,health plans,and government agencies to aggregate and integrate healthcare claims data and other information from diverse sources and systems;organize,standardize,and enhance the data;and conduct sophisticated analyses that inform and improve management decisionmaking. The new release allows integration of users’own data sources, reporting tools, and systems. It also features a portal that accesses Thomson Healthcare applications and thought leadership, as well as customized reports and executive dashboards. For more information, visit thomsonhealthcare.com. 99 PharmaVOICE M a y 20 08 PV0508 Issue FINAL2 4/23/08 10:39 AM Page 99 100 M a y 20 08 PharmaVOICE Emedia COMPASSHEALTHCARE COMMUNICATIONS,Princeton,N.J., is an independent, fullservice online marketing agency that supports brands in the healthcare industry. For more information, visit compasshc.com. DRUGLOGIC INC., Reston,Va., develops and markets drug safety data and analytical tools for managing risks related to drugsafety Follow up issues. For more information, visit druglogic.com. EDRUGSEARCH.COM,San Antonio, is a health 2.0 community and search engine for U.S. consumers seeking prescription medications from prescreened Canadian and other international pharmacies.For more information, visit edrugsearch.com. EXCO INTOUCH,Harlow,United Kingdom, provides global, secure, and regulatory compliant SMS technology to the healthcare industry. For more information, visit excointouch.com. PHASE FORWARD INC.,Waltham,Mass., is a provider of integrated datamanagement solutions for clinical trials and drug safety. For more information, visit phaseforward.com. QscanClinical Monitors DRUG SAFETYTHROUGHOUTCLINICAL DEVELOPMENT DrugLogic has introduced QscanClinical, a workflow database and analytical system that employs marketed drug label data to assist in comparator study design and data analysis throughout all phases of clinical development. Drugsafety risk management in the clinical development phase too often is relegated to serious adverse event reporting and the accumulation of development core safety information that ulti mately defines the label data.Apart from the search for adverse events by the drug safety board, little attention is given to the emerging drug safety profile, in which a particu lar drug may be a safety issue for only a subset of patients. QscanClinical analytics can help identify situa tions that tailor the development of a drug to a spe cific population or assist in drug repositioning efforts. The solution allows companies to monitor drug trials Phase Forward has introduced Empirica Trace, a significant new release of the company’s adverse event reporting software, former ly known as Clintrace. Empirica Trace is designed to enhance regulatory compliance and improve efficiency, reliability, and performance for drugsafety users. The Empirica Trace software provides a single solution that helps organizations collect,code,analyze,and report adverse events to meet global regulatory reporting requirements. The product’s streamlined, Webbased architecture enables rapid deployment to multiple browserbased clients and helps minimize operations and support costs. Important new features of Empirica Trace include global report distribution, quick data entry and triage, case lists, Structured Med DRA Query (SMQ) support, and expanded search and adhoc query capabilities. The new rulesbased report distribution func tionality provides automated generation and delivery of reports based on case characteristics, product identity, and recipient requirements. With this launch, Phase Forward has unified its safety products under the new family name Empirica for its suite of pharmacovigi lance and riskmanagement products. Using Empirica Trace as its foundation, the suite includes an electronic case submissions mod ule (ECSM), a Web visual data mining environment (WebVDME), a signal management module, and a clinical trials signal detection (CTSD) system.The Empirica products are managed by the compa ny’s Lincoln Safety Group. “For the biopharmaceutical industry and regulatory agencies, the spotlight is onproduct safety as never before,”says Chan Russell, president of Phase Forward’s Lincoln Safety Group.“With its modern architecture, ease of configuration, and automated report distribu tion capabilities, we believe the Empirica Trace product will help sponsors, government agencies, and CROs streamline adverse event management and regulatory compliance.” in real time and to begin to explore the types of genomic, proteomic, and phenotypic data that are the foundation of personalized medicine. During a time when many companies are being forced to do more with less, QscanClini cal not only facilitates develop ment of safer drugs, but provides a timetomarket competitive value with fewer adverse events. “We are excited to be able to offer a solution that integrates pre and postmarket data, public as well as proprietary data, and extends the drug safety warehouse of knowledge to a vast array of information often buried in prelaunch data,” says Colette Saccomanno, Ph.D., director of client research at DrugLogic. “What we offer is an easily tailored process — including a `starter set’ workflow — that allows researchers to fully evaluate incoming data, make timely adaptive clinical trial design modifications, plan better active comparator trials, and review reallife experience in medical practice.” The analytic capabilities in QscanClinical provide an easy way for companies to enter this complex area of drug development with tools that facilitate the visualization and comprehensive analysis of data found in the hundreds of millions of clinical trial data elements and SAS tables. QscanClinical builds on the Qscan family of products and adds three key components: . Pro ess management: a multisite and multi workflow system that can parallelprocess multi ple databases. The system maintains a full audit trail for regulatory compliance. . Comprehensive, integrated safety data: a set of quantified label and listing information, available only as text in product information, translated and mapped for integration and comparison with both clinicaltrial data and postlaunch reports. . Proprietary analytics: a “differencing engine” that can be used for multiarm comparisons and to apply techniques such as statistical control charting. QscanClinical analytics can help identify situations that tailor the development of a drug to a specific population or assist in drug repositioning efforts. Phase Forward Launches ADVERSE EVENT REPORTING SOFTWARE For the biopharma industry and regulatory agencies, the spotlight is on product safety as never before, says Chan Russell, President of Phase Forward’s Lincoln Safety Group. PV0508 Issue FINAL2 4/23/08 10:39 AM Page 100
