4 Strategy Life Sciences Healthcare Convergence Accelerate clinical developmentSupport entire drug safety lifecycleEnable clinical data aggregationPower enterprise healthcare analyticsEnable provider/payer integrationDrive personalized medicineIntersection of clinical trials and clinical careDevelop collaboration networks for providers and life sciences companiesThe Oracle Health Sciences Strategy is actually pretty simpleWe recognize that our customers are at different points of the spectrum when it comes to the convergence of life sciences and healthcareWe’re helping our customers maximize their capabilities at every stage and we are at the forefront of the accelerating convergence waveI’ll be talking more about our innovation in life sciences but it’s important to know we are leaders in the healthcare arena as well-For example our translational research and enterprise healthcare analytics solutions are powering the Moon Shots program at MD Anderson Cancer Center…UPMC’s aggregation of clinical, genomic, financial, administrative, and operational data from over 200 different sources…and the Mayo Clinic’s single infrastructure for storage, integration, and management of all their genomic data
5 Clinical Research and Development Solutions Delivering End-to-End Value Oracle delivers advanced transformative value for clinical R&D in a modular, integrated and scalable cloud environment and helps you:Optimize OperationsWith technology that helps you maximizeefficiency across your clinical life cycleInnovateBy incorporating genomics, biomarkersand real-world patient dataFuture-Proof your BusinessWith a platform that evolves and grows with you and the industryGain Actionable InsightsFrom aggregated clinicaland healthcare data-What are some of the ways we do that?-We continually develop pragmatic yet innovative solutions that optimize and fundamentally improve the current landscape of clinical R&D, such as activity-based planning, mobile monitoring, and direct patient-to-EDC data capture through digital sensors-Our strengths in data management and our ability to bring the data together and accessible to our comprehensive analysis tools drive better insights and decision- making-We are facilitating the collection and use of genomic and healthcare data in clinical trials to conduct more effective trials and derive improved outcomes and safety monitoring-Finally, Oracle Health Sciences’ significant and ongoing commitment to research and development, and the breadth of our platform, provides a level of innovation and support that ensures you will have a partner for the long term to grow with you as our industry evolves
6 Clinical R&D Platform : Pipeline to Patient Optimized and integrated processes across the clinical development landscapeStudy ConnectIdentity Access MgtPlanningWorkflow, Clinical Data Model, MDM, MDR, CDR, AnalysisLSW CLOUDCDA Trial AnalyzerRisk-Based Monitoring Planning and SimulationCDA CloudClinical Performance BenchmarksIRTTrial Supply Mgt. ForecastingPlan Track SourceClearTrialInvestigator Network/PortalGrants ForecastCROSite QualityMetricsThird PartyData SourcesTrial InitiationHSNPt RecruitProtocol ValidationStudy Start-Up and DesignProtocol CollaborationTrial InitiationThird PartyStudy Design ToolsTrial ConductIRT (RTSM)ArgusCTMSMonitoring CloudData Capture & Data MgtInFormOC RDC / TMS (Hosted)Site ReimbursementPayments AnalyticsCDAInForm / Central DesignerInForm Medical Adherence InsightsMedical ImagingEnd Point AdjudicationMobile CRAInForm UtilitiesCRF SubmitInForm Molecular AnalyticseTMFSubmission/ AnalysiseCTD GatewayStandards GatewayLSH / DMW / SCELSW CloudPost-MarketingEHR (HSN)eCOA / MHealthInForm Late PhaseCTMS Cloud/ Call CentreOMICS DatabankPatient Device M2M NetworksLSW CloudArgusEmpiricaVia Integrated Technology Partners
7 Oracle Delivers the Most Advanced and Easy-to-Use Closed-loop Clinical Trial Management Offering PlanOracle ClearTrialBuilds study plans based on actual study activitiesForecasts and budget resources, costs, units and timelinesSourceOptimizes allocation of resources using simulationsConsolidates projects on portfolio levelHelps negotiate and manage RFPs and contractsExecuteOracle CTMS, Oracle IRTDesigns, codes and randomizes trialsManages clinical trial executionCapture DataOracle Inform and OC/RDCCaptures clinical trial data electronicallyAggregates and maintains clinical trial data centrallyAnalyzes clinical trial operations and outcome dataTrackTracks project status and accrualsAssesses strategy and automatically re-forecastsPayOracle Financials, Oracle PeopleSoft FinancialsMakes payments from financial systemsImproveAnalyzeSourceExecutePlanCapture DataTrackPay
8 Oracle Health Sciences Clinical Monitoring Suite Purpose-Built Solution for Today’s Complex Trial EnvironmentData Warehousing—Clinical Data Integration, Validation, and Cleansing Oracle Health Sciences Data Management WorkbenchTrial ManagementSiebel Clinical Trials Management SystemContacts Management and CollaborationSiebel Base CRM for Clinical Trials ManagementSite Monitoring VisitsOracle Health Sciences Mobile CRATablet-based Trip Reporting (Disconnected support)Site Check-in for ComplianceAnalytics and ReportingOracle Health Sciences Clinical Development AnalyticsFinance and Investigator PaymentsSiebel CTMS PaymentsInvestigator Payments PIPAdaptive MonitoringSiebel CTMSClinical Development AnalyticsMobile CRAHSGBU Data Management SuitesSafety Data and Reporting Oracle Argus Safety & Empirica ToolsData Management and Collection Oracle Health Sciences InForm GTM SuiteOracle Clinical / Remote Data CaptureClinical Trials Management SystemProven ScalabilityMultilingual SupportBusiness IntelligenceClinical Process AutomationComplex Trial SupportOpen UIInteroperability and IntegrationSiebel Enterprise Application IntegrationPrebuilt integrations to HSGBU SuiteDocument ServerMS-Office, Outlook Calendar integrationMail MergeTrial Planning and ForecastingOracle Health Sciences ClearTrial
9 Clinical Monitoring Cloud Offering (User Access SSO IDMMonitoring CloudCTMS: Industry leading solution with new Open UI interfaceCDA: Analytical insights to support faster decision-makingSupport: Tier I and Tier II supportvia HSGBU and Product SupportMobile CRA: Study awareness and streamlined site visits via mobilityClinical R&D CloudManage: Application Monitoring, DR, Lifecycle
11 What’s New: Oracle Clinical Operations Cloud Service Unlock the Full Value of Your InvestmentClinical R&D CloudAccelerated ImplementationsBetter Compliance at Lower CostLower TCO and Infrastructure CostsImproved Processes and ControlsProactive Patches and UpdatesReduce IT Management Time and EffortReduced Upgrade Risk and DowntimeFar Fewer Average Service RequestsWorld-Class Security and ComplianceReady-To-Go Environments for faster time to valueAccelerators to leverage industry best practicesAnywhere, Anytime Availability via Web24x7 SupportOracle Cloud Services customers realize significant, measurable benefits and business value.MORE VALUE.MORE CHOICE.MORE CONFIDENCE.
12 We always leverage our vast CTMS collateral Leverage our industry library of CTMS requirements and processesA large library of pre-built Siebel CTMS processesMaintain a library of out of the box and pre-configured CTMS functionality to guide workshopsUtilize a Virtual Prototyping Environment to accelerate requirements and design sessionsAccess to our library of CTMS implementation artifacts
13 CTMS Accelerators leverage industry best practices to speed time to value Based on Leading Practices for:Pre-built CTMS Process Flows and Accelerator ConfigurationsDocument ManagementTrip ReportingInvestigator Candidate Identification and AssessmentsStudy SetupProtocol Authoring and ApprovalInformed Consent, Investigator Brochure and Subject Materials PreparationCRF DesignSubject Visit Template SetupSelect and Initiate Partners for StudySite SelectionMonitoring/Site EvaluationRandomization Request and FulfillmentSite Initiation PackageScreening and Enrollment TrackingScreening and Enrollment – IVRSMonitoring – Site InitiationMonitoring - Interim MonitoringMonitoring – CloseoutClinical Supplies PlanningEach Package includes:Pre-configuration Install FileHigh Level Design SpecificationFunctional RequirementDesign ApproachStep-by-Step Installation and System Testing instructions
14 Modernize with Siebel Open UI / Siebel Mobile Enhanced User Experience: Maximize productivityAny Browser: Flexible deploymentTemplates: Create your own user experiences quicklyAny Device: Choose your platform with automatic device renderingCoexist: Leverage existing Siebel investmentsAdvanced Standards: Tailor readily with common tech skillsSimplified Integration: Reduce total cost of ownership
15 Open UI Customization Possibilities Themes: style for familiarity or brandCustomer Dashboard: View top information on a single screenIndustries: plan, perform, and track field sales and service activitiesWeb Self-Service: empower customer self help
16 Mobile: Native look and feel “Designed for Mobile”Device driven rendering; Infinite scrollingIntegration with native Phone, PIM, location based integrationMulti-touch gesturing (mobile) and HTML5Offline mode with synchronization (TBD)
17 Use Case: How We Support Risk-Based Monitoring Adaptive MonitoringUse Case: How We Support Risk-Based MonitoringFollowing FDA, EMA, TransCelerateQuality by Design (QbD): Risk-based trial planning and impact simulationQuality Mgt IndicatorsCompliance IndicatorsPerformance indicatorsPredictive risk simulationsClinical Data AnalyticsSubject SafetyCompliance & PerformanceDataIntegrityProtocol DeviationsData Entry & ApprovalData CleanlinessFollow Up ItemsSite Visit FrequencyScreen Failure RateSubject Withdrawal RateTMF ComplianceClinical SuppliesSDVEnrollment RateSubject Visits Out of WindowVisit Report ContentsHistorical Clinical DataSAEsCurrent Clinical DataHistorical Site PerformanceHistorical Investigator PerformanceAEsEDCOC/RDC & InFormQuality by Design (QbD)Source Data Verification (SDV)Source Data Review (SDR)CTMSSiebel Clinical/CDA/MCRASDR: quality & complianceOffsite/central monitoringInvestigator quality and qualitative performanceMobilityMobile CRASDVSDR (protocol compliance, site processes, documentation quality)Risk and Quality controlsSafetyArgus/EmpiricaRisk Scores/IndicatorsRisk-based inspectionsSignal Detection AnalysisGOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies
19 Risk-Based Monitoring Oracle’s Multi-System Holistic Approach Clinical Dashboards & ReportsAccess, Planning, &CollaborationMobile CRAMobileClearTrialPlanningCustomer PortalAnalyticsClinical Development AnalyticsArgus AnalyticsAnalytics, Insight, & Content MgmtRisk AnalysisSignal and Risk ManagementEmpirica StudyEmpirica TopicsWarehouseLife Sciences Data HubClinical Warehouse & Data MartsInFormEDCOC/RDCExternal 3rd Party Data, ProgramsSource Data& SystemsArgusSafetyTrials ManagementSiebel CTMSSuite Integration & Open Interfaces
20 Risk-Based Monitoring Oracle’s Multi-System Holistic Approach Provide continuous monitoring of study and site dataSupport multiple methodologies for streamlining site monitoring through targeted SDVSingle global safety repository ensuring risk monitoring of subject safetyAccess to historical quantitative and qualitative site and investigator performance;Drive down costs leveraging Oracle’s pre-built integrations and open interfaces to enable RBM PlansExtensibility to incorporate data and programs from customer applications in the clinical ecosystem (e.g. EDC, CTMS, Lab, ePro, eTMF, etc.)Over 90% OOTB coverage of risk indicators identified in TransCelerate position paperIncorporating customer specific systems and processes via open interfacesEnabling real-time access to actionable insights for decision making through MobilityUpfront risk based trial planning via ClearTrialBy leveraging existing investments and Oracle technology to drive down costsGOAL: Enable Life Sciences customers to deploy Centralized and Risk Based Monitoring StrategiesSiebel CTMSSuite Integration & Open InterfacesExternal 3rd Party Data, ProgramsInFormArgusOC/RDCLife Sciences Data HubEmpirica StudyEmpirica TopicsRisk AnalysisArgus AnalyticsClinical Development AnalyticsCustomer PortalMobile CRAClinical Dashboards & ReportsClearTrialWhile ensuring data integrity, subject safety and compliance
22 Enabling Operational Performance Management from Sites to Execs ORACLE CLINICALDEVELOPMENT ANALYTICSExecutiveTeamOrganizationalProgressHead of ClinicalOperationsDepartmental /RegionalProgressCRA /Data ManagerStudyProgressClinical SitesSiteProgress
23 Cloud-Based Delivery of Site Performance and Risk Analysis • Users access information and analytics through role-based dashboards• Can also publish reports to PDF, distribute, or access through MS OfficeClinical R&D Cloud
24 CDA’s Interactive Reports Provide Actionable Clinical Insight BusinessObjectives/IssuesAccelerate EnrollmentIs Program on target?Drill to DetailWhich studiesare behind?GainInsightsWhich sites areslowest recruiters?Drill to Site DetailTake ActionCall Site to UnderstandLow Enrollment2424
25 Event-Driven Clinical Insights via Alerts and Reports BusinessObjectives/IssuesMaximize Data QualityNew Site Coordinator mid-study (site turnover)Event logged on Exception ReportRiskIdentifiedStudy Manager reviews exceptions dailyVisit Schedule for site is updated with new site visitTake ActionSDV Plan updated for study site (e.g. 100% for next 5 subjects)2525
27 Mobile CRA Vision Briefcase Support View SOP’s Annotation & Bookmarks Device IntegrationsNotification & Offline supportGPS/Location capture for Trip ReportNative contacts listing and CalendarEDCView of Source Data available for visitSummary of Source Data Verified in Trip ReportMobile CRAEDCCDACTMSGamif-icationArgusOpen Alerts/SaaGVoiceBriefcaseBriefcase SupportView SOP’sAnnotation & BookmarksSite ComplianceClinical Development AnalyticsSite MetricsAlertsVoice Notes & Voice TranslationSpeech to Text for Trip Report NotesCTMSTrip ReportContacts and Site informationCalendarOpen Alerts & SaaGIntegration with 3rd party External & Internal systemSafetySerious Adverse Event review and verification2727
28 Mobile CRA Mobilizing Clinical Trial Monitoring Site-At-A-Glance Provides study site focused performance indicators in a single view so CRAs have up-to-date site progress information at their fingertips, enabling more efficient, proactive planning and more productive site visitsStudy Alerts and NotificationsAlerts CRAs of key milestones, activities and potential issues for the study sites they are monitoring, enabling them to respond quickly to potential issues that may affect key milestones for the overall studyTablet-based Trip ReportingRevolutionizes trip reporting with the ability to download, complete and upload trip reports through a lightweight, intuitive role-focused app on a mobile tabletCTMS Contacts SynchronizationMakes available up-to-date site contact information maintained in your global clinical database so that communication with site via phone, , or travel is faster and easier
29 Mobile CRA Simplifying Site Visits Simplified Monitoring for Traveling CRAsProvides more efficient workflows for upfront planning, on-site execution and final closeout activities of site visits while facilitating compliance to industry guidance and best practicesStudy Site Check-InCaptures site check-in details of traveling CRAs for each site visit to be stored on the trip report so compliance to site monitoring requirements can be demonstrated via geo-location information captured while onsiteNative Mobile AppProvides an optimum end-user experience benefiting from native capabilities of mobile devices, e.g. GPS, Contacts integration, Messaging, etc.
30 Clinical Monitoring Suite CDA 3.XSourcing un-sourced MeasuresEnhancements of Risk-Based MonitoringAdditional measures from CTMS/EDCAction Framework for supporting actions back to source systemsNew Monitoring Dashboards/Reports - User driven thresholds at Study, Project, Indication, TAMobile CRA 2.0Inline InForm SDVSingle, unified interface for field monitorsAutomated SDV tracking and update to Trip ReportNuance Voice RecognitionIAMS integrationClinical Monitoring SuiteClinOps Cloud Suite OfferingNew subscription-based model for CTMS / CDA / Mobile CRA offering hosted in the Oracle CloudCTMS FPWeb Services to support retrieval of protocol, site, and site visit informationCapture of geo-location related to Mobile CRACTMS FPOpen UI CertificationFresh, Modern UIBrowser IndependenceSupport for StandardsMobility SupportMobile CRA 1.XAndroid Device Support- Phone, Phablet, Tablet201220132014CTMS 2012-IPComplex Trials / Trip Report WorkflowSupport multi-arm flexible trial designTrip Report EnhancementsReviewer/Approver fields & statusNew State ModelNew Layout / Approvals / Audit Trail viewsAdd’l Integration ObjectsCDA 2.2Enabling Comprehensive and Detailed Insight Milestone & cycle time performance managementKey performance indicators & targets at multiple levelsNew executive and region-level dashboardsAround 50 new pre-built reports and 33 new dashboard pagesMobile CRA 1.0Guided Site MonitoringStudy Progression Awareness,Streamlined Site CollaborationCTMS 2013-IPTrip Report SimplificationData Driven Trip ReportsConfigurable on the flyReal-time response branchingComprehensive feedback for trip report reviewPayment EnhancementsSplit paymentsMultiple PayeesRevert paymentsVAT supportCDA 3.0Support for Sourcing InForm StudiesInForm 4.6 or later as a transactional sourceDM Metrics aggregated by RegionMobile CRA 1.2Open SaaG / AlertsConfigurable Site-at-a-GlanceOpen Site-At-A-GlanceOpen AlertsCTMS 2014-xRisk-Based MonitoringSDV Plans and PoliciesSite Assessment - New Site Assessment fields - Support new interfacesNew RBM fields (driven by TransCelerate)Integrations - InForm - ClearTrialCDA 3.1Oracle Data Integrator (ODI) Support for ETL in addition to InformaticaMove to ODI for CDA CloudSupport for ODI and Informatica on-premiseTop Add’l Clinical Monitoring Suite Candidates in and into 2015Study Risk Simulation ToolSupport risk simulation and what- if scenarios providing scores by risk category based upon historical data during the upfront planning and course of a clinical trialClinOps Cloud Suite Refresh (CTMS 2013 / CDA 3.0 / MCRA 1.3 with InForm and IAMS integration)Product Integrations - ClinOps Suite to IAMS - CTMS to QUMAS - CTMS to GreenPhire - CTMS to Financials - CDA to ClearTrial - Mobile CRA to Nuance - Mobile CRA to InForm
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