Improve Trial Efficiency & Quality With CTMS

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaImprove Trial Efficiency &Quality with CTMSRachel Yang, M.D. Ph.DDirector, Product StrategyOracle Health Sciences GlobalBusiness Unit

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaAgenda General trends, and challenges of clinicaltrial industry What it means from clinical trialmanagement perspective– Examples Benefits of clinical trial managementsystem (CTMS)

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaChallenges in Conducting Clinical Trials Globalization of R&DOutsource trendShortage of quality investigatorsPatient recruitment bottleneckComplex global multi-center clinical trialsIncreasing importance of post-marketing studiesSystem proliferation -- integration a mustData-rich but information-poor

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaGlobal Trial and Global OperationsFacts Significant shift fromNorth America toWest Europe.– % of trials inNA/WE fall to38% from 55%– 56% sitesregistered areoutside of US Global markets offerhuge cost saving &growing markets Large researchtalent poolCTMS Implication Languages, currencies, time/dateformat, time zones Support local business practices Comply with local reg. mandates Integrate with global clinicalsupply chain (nimble, costeffective) Enable collaboration &information sharing acrossregions Maintain a unified database of allclinical trials

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaFind the Right InvestigatorsFacts A continuing declinein US investigators An increase use offirst-time investigators Poor investigatorretention—more than50% investigatorsnever conduct 2nd trial High qualityinvestigators indeveloping marketsCTMS ImplicationIdentify valuable investigators andkeep them by: Know your investigators Focus on high-value investigators– Leverage analytics tools– Grease the “squeaky wheels”only when necessary Provide info/tools to makeinvestigator’s life easier Pay investigators right & quick Extend the horizon – buildinternational network

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaTarget & Screen for Potential InvestigatorsTherapeutic area: OncologyPast 12 months # ofprescriptions: 10Board certification: YesFDA blacklist: NeverPast Trail Performance Percentile:Top 50%Responsiveness of Local IRB:HighAvailability of MRI: Yes Search Inv. DB,Use BI ToolsCreate target listDefine Search CriteriamailWeb &EmailCall CenterFieldApply Target List forCorrespondence, Fax,Email, etc.Multi-channel Campaign,investigator Recruitment

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaBuried with Data, but Starved for InformationKEY CHALLENGESEXAMPLESLack of visibility intostudy performance &processes Limited understanding of CRF data flow Poor recruitment forecast accuracy Lack of CRA coverage visibilityLack of site insightto recruit mosteffectively No comprehensive (360 ) view of site relationship Lack insight into site effectiveness Unable to identify high value from low value sitesUnable to drive CRAprocess consistencyand best practices Low/inconsistent adoption of CTMS system by CRAs Poor or inconsistent data quality Unable to drive consistent study process and complianceTime wastedgathering data tomanage and report Continued reliance on management-by-spreadsheetDisparate reporting and poor internal distributionData in multiple systems – EDC, CTMS, IVRS, FinancialNo single source of the truth7

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaTurning Data into Insight

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaBusiness Intelligence For Everyone123Integrates Data for Analysis and Reporting Pre-built integration of data from Oracle Clinical/RDC, Siebel Clinical, Oracle AERSand other sources into an integrated data warehouse optimized for analysisProvides User-Friendly Analytic Model of Enterprise Information and Metrics Embedded best practice calculations, metrics, and KPIs Easy for business people to access, analyze, and use the informationDelivers Personalized Performance Dashboards for Everyone Pre-built dashboards, reports, and alerts by business function and role123

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaActionable Analytic WorkflowsBusinessObjectives/IssuesAccelerate EnrollmentIs Program on target?Which studiesare behind?GainInsightsWhich sites areslowest recruiters?Drill to Site DetailTakeActionCall Site to UnderstandLow EnrollmentDrill toDetail

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaWider Adoption of eClinical Technology

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaIntegration Headache Point-to-point integration is insufficient andcostly to build and maintain Standard based, integration “hub” providesa more desirable solution with lower TCO SOA based solution breaks down thetraditional application barriers, and enablescross-application business flows

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaBusiness without Boundaries SOA Approach toProcess ly bepartpartofoftheanswerthe answerbybyprovidingasoundproviding a otohelphelpCIOsaddresstheirCIOs address ney,Kenney,Research DirectorResearch DirectorQuote source: Gartner Symposium/ITxpo: Emerging Trends, April, 2007

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaProcess Integration in Clinical sit ScheduleVisit ScheduleVisit ScheduleVisit ScheduleVisit ScheduleVisit tLegacyeDiary

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaCustomer Reported CTMS BenefitsReduced Site Initiation time to 10 weeks from 12 weeksReduced CRA monitoring effort by 30%Reduced Subject Enrollment time to 16 weeks from 25-30 weeksReduced system support costs by 50% vs previous custom systemReduced man-hours required for investigator payment processing: 500,000/yrEliminated payments for missed visits: From 3% of payments to 0%Reduced travel expenses by 15%Reduced monitoring visits by 10%-20%Consolidated real-time view of trial status: Reduced to days from weeksGlobally standardized processes, enhanced complianceBetter and more timely decisions: Qualitative estimatesSupports better customer experience for investigators and sitesAllows for early recognition of progress/ quality issues at sites

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaLeveraging Clinical Trial Technology for Efficiency andQuality Improvement More and more companies in North America andEurope have deployed enterprise CTMS, and start toreap the benefits brought about by an efficient trialmanagement process. Opportunities abound for organizations in developingmarkets to leverage the experience in developedmarkets, and establish new ways to increasinglyefficiency, effectiveness and quality of trials usingclinical trial technologies.

2nd DIA China Annual Meeting May 16-19, 2010 Beijing, ChinaThank YouDrug Information Associationwww.diahome.org

retention—more than 50% investigators never conduct 2 nd trial High quality investigators in developing markets Facts CTMS Implication Identify valuable investigators and keep them by: Know your investigators Focus on high-value investigators - Leverage analytics tools - Grease the "squeaky wheels" only when necessary