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Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud

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Presentation on theme: "Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud"— Presentation transcript:


2 Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud
This is a Title Slide with Picture slide ideal for including a picture with a brief title, subtitle and presenter information. To customize this slide with your own picture: Right-click the slide area and choose Format Background from the pop-up menu. From the Fill menu, click Picture and texture fill. Under Insert from: click File. Locate your new picture and click Insert. To copy the Customized Background from Another Presentation on PC Click New Slide from the Home tab's Slides group and select Reuse Slides. Click Browse in the Reuse Slides panel and select Browse Files. Double-click the PowerPoint presentation that contains the background you wish to copy. Check Keep Source Formatting and click the slide that contains the background you want. Click the left-hand slide preview to which you wish to apply the new master layout. Apply New Layout (Important): Right-click any selected slide, point to Layout, and click the slide containing the desired layout from the layout gallery. Delete any unwanted slides or duplicates. To copy the Customized Background from Another Presentation on Mac Click New Slide from the Home tab's Slides group and select Insert Slides from Other Presentation… Navigate to the PowerPoint presentation file that contains the background you wish to copy. Double-click or press Insert. This prompts the Slide Finder dialogue box. Make sure Keep design of original slides is unchecked and click the slide(s) that contains the background you want. Hold Shift key to select multiple slides. Apply New Layout (Important): Click Layout from the Home tab's Slides group, and click the slide containing the desired layout from the layout gallery. James Streeter Senior Director Life Sciences Product Strategy HSGBU October 1, 2014 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. |

3 Safe harbor statement.

4 Strategy Life Sciences Healthcare Convergence
Accelerate clinical development Support entire drug safety lifecycle Enable clinical data aggregation Power enterprise healthcare analytics Enable provider/payer integration Drive personalized medicine Intersection of clinical trials and clinical care Develop collaboration networks for providers and life sciences companies The Oracle Health Sciences Strategy is actually pretty simple We recognize that our customers are at different points of the spectrum when it comes to the convergence of life sciences and healthcare We’re helping our customers maximize their capabilities at every stage and we are at the forefront of the accelerating convergence wave I’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 Operations With technology that helps you maximize efficiency across your clinical life cycle Innovate By incorporating genomics, biomarkers and real-world patient data Future-Proof your Business With a platform that evolves and grows with you and the industry Gain Actionable Insights From aggregated clinical and 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 landscape Study Connect Identity Access Mgt Planning Workflow, Clinical Data Model, MDM, MDR, CDR, Analysis LSW CLOUD CDA Trial Analyzer Risk-Based Monitoring Planning and Simulation CDA Cloud Clinical Performance Benchmarks IRT Trial Supply Mgt. Forecasting Plan Track Source ClearTrial Investigator Network/Portal Grants Forecast CRO Site Quality Metrics Third Party Data Sources Trial Initiation HSN Pt Recruit Protocol Validation Study Start-Up and Design Protocol Collaboration Trial Initiation Third Party Study Design Tools Trial Conduct IRT (RTSM) Argus CTMS Monitoring Cloud Data Capture & Data Mgt InForm OC RDC / TMS (Hosted) Site Reimbursement Payments Analytics CDA InForm / Central Designer InForm Medical Adherence Insights Medical Imaging End Point Adjudication Mobile CRA InForm Utilities CRF Submit InForm Molecular Analytics eTMF Submission/ Analysis eCTD Gateway Standards Gateway LSH / DMW / SCE LSW Cloud Post-Marketing EHR (HSN) eCOA / MHealth InForm Late Phase CTMS Cloud/ Call Centre OMICS Databank Patient Device M2M Networks LSW Cloud Argus Empirica Via Integrated Technology Partners

7 Oracle Delivers the Most Advanced and Easy-to-Use Closed-loop Clinical Trial Management Offering
Plan Oracle ClearTrial Builds study plans based on actual study activities Forecasts and budget resources, costs, units and timelines Source Optimizes allocation of resources using simulations Consolidates projects on portfolio level Helps negotiate and manage RFPs and contracts Execute Oracle CTMS, Oracle IRT Designs, codes and randomizes trials Manages clinical trial execution Capture Data Oracle Inform and OC/RDC Captures clinical trial data electronically Aggregates and maintains clinical trial data centrally Analyzes clinical trial operations and outcome data Track Tracks project status and accruals Assesses strategy and automatically re-forecasts Pay Oracle Financials, Oracle PeopleSoft Financials Makes payments from financial systems Improve Analyze Source Execute Plan Capture Data Track Pay

8 Oracle Health Sciences Clinical Monitoring Suite
Purpose-Built Solution for Today’s Complex Trial Environment Data Warehousing—Clinical Data Integration, Validation, and Cleansing Oracle Health Sciences Data Management Workbench Trial Management Siebel Clinical Trials Management System Contacts Management and Collaboration Siebel Base CRM for Clinical Trials Management Site Monitoring Visits Oracle Health Sciences Mobile CRA Tablet-based Trip Reporting (Disconnected support) Site Check-in for Compliance Analytics and Reporting Oracle Health Sciences Clinical Development Analytics Finance and Investigator Payments Siebel CTMS Payments Investigator Payments PIP Adaptive Monitoring Siebel CTMS Clinical Development Analytics Mobile CRA HSGBU Data Management Suites Safety Data and Reporting Oracle Argus Safety & Empirica Tools Data Management and Collection Oracle Health Sciences InForm GTM Suite Oracle Clinical / Remote Data Capture Clinical Trials Management System Proven Scalability Multilingual Support Business Intelligence Clinical Process Automation Complex Trial Support Open UI Interoperability and Integration Siebel Enterprise Application Integration Prebuilt integrations to HSGBU Suite Document Server MS-Office, Outlook Calendar integration Mail Merge Trial Planning and Forecasting Oracle Health Sciences ClearTrial

9 Clinical Monitoring Cloud Offering
( User Access SSO IDM Monitoring Cloud CTMS: Industry leading solution with new Open UI interface CDA: Analytical insights to support faster decision-making Support: Tier I and Tier II support via HSGBU and Product Support Mobile CRA: Study awareness and streamlined site visits via mobility Clinical R&D Cloud Manage: Application Monitoring, DR, Lifecycle


11 What’s New: Oracle Clinical Operations Cloud Service
Unlock the Full Value of Your Investment Clinical R&D Cloud Accelerated Implementations Better Compliance at Lower Cost Lower TCO and Infrastructure Costs Improved Processes and Controls Proactive Patches and Updates Reduce IT Management Time and Effort Reduced Upgrade Risk and Downtime Far Fewer Average Service Requests World-Class Security and Compliance Ready-To-Go Environments for faster time to value Accelerators to leverage industry best practices Anywhere, Anytime Availability via Web 24x7 Support Oracle 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 processes A large library of pre-built Siebel CTMS processes Maintain a library of out of the box and pre-configured CTMS functionality to guide workshops Utilize a Virtual Prototyping Environment to accelerate requirements and design sessions Access 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 Configurations Document Management Trip Reporting Investigator Candidate Identification and Assessments Study Setup Protocol Authoring and Approval Informed Consent, Investigator Brochure and Subject Materials Preparation CRF Design Subject Visit Template Setup Select and Initiate Partners for Study Site Selection Monitoring/Site Evaluation Randomization Request and Fulfillment Site Initiation Package Screening and Enrollment Tracking Screening and Enrollment – IVRS Monitoring – Site Initiation Monitoring - Interim Monitoring Monitoring – Closeout Clinical Supplies Planning Each Package includes: Pre-configuration Install File High Level Design Specification Functional Requirement Design Approach Step-by-Step Installation and System Testing instructions

14 Modernize with Siebel Open UI / Siebel Mobile
Enhanced User Experience: Maximize productivity Any Browser: Flexible deployment Templates: Create your own user experiences quickly Any Device: Choose your platform with automatic device rendering Coexist: Leverage existing Siebel investments Advanced Standards: Tailor readily with common tech skills Simplified Integration: Reduce total cost of ownership

15 Open UI Customization Possibilities
Themes: style for familiarity or brand Customer Dashboard: View top information on a single screen Industries: plan, perform, and track field sales and service activities Web Self-Service: empower customer self help

16 Mobile: Native look and feel
“Designed for Mobile” Device driven rendering; Infinite scrolling Integration with native Phone, PIM, location based integration Multi-touch gesturing (mobile) and HTML5 Offline mode with synchronization (TBD)

17 Use Case: How We Support Risk-Based Monitoring
Adaptive Monitoring Use Case: How We Support Risk-Based Monitoring Following FDA, EMA, TransCelerate Quality by Design (QbD): Risk-based trial planning and impact simulation Quality Mgt Indicators Compliance Indicators Performance indicators Predictive risk simulations Clinical Data Analytics Subject Safety Compliance & Performance Data Integrity Protocol Deviations Data Entry & Approval Data Cleanliness Follow Up Items Site Visit Frequency Screen Failure Rate Subject Withdrawal Rate TMF Compliance Clinical Supplies SDV Enrollment Rate Subject Visits Out of Window Visit Report Contents Historical Clinical Data SAEs Current Clinical Data Historical Site Performance Historical Investigator Performance AEs EDC OC/RDC & InForm Quality by Design (QbD) Source Data Verification (SDV) Source Data Review (SDR) CTMS Siebel Clinical/CDA/MCRA SDR: quality & compliance Offsite/central monitoring Investigator quality and qualitative performance Mobility Mobile CRA SDV SDR (protocol compliance, site processes, documentation quality) Risk and Quality controls Safety Argus/Empirica Risk Scores/Indicators Risk-based inspections Signal Detection Analysis GOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies

18 Transcelerate & CDA Risk Category Mappings
Indicator Analytical & Reporting Marts Clinical Transactional Applications Category Clinical Development Analytics (CDA) Argus Analytics CTMS EDC Inform & OC/RDC Empirica Argus Safety IRT Safety X Investigational Product Subject Recruitment and Discontinuation Management General Issues Data Quality CRF Completion Discrepancy Management On-site Workload-Based Triggers Essential Documents Staffing, Facilities, and Supplies

19 Risk-Based Monitoring Oracle’s Multi-System Holistic Approach
Clinical Dashboards & Reports Access, Planning, & Collaboration Mobile CRA Mobile ClearTrial Planning Customer Portal Analytics Clinical Development Analytics Argus Analytics Analytics, Insight, & Content Mgmt Risk Analysis Signal and Risk Management Empirica Study Empirica Topics Warehouse Life Sciences Data Hub Clinical Warehouse & Data Marts InForm EDC OC/RDC External 3rd Party Data, Programs Source Data & Systems Argus Safety Trials Management Siebel CTMS Suite Integration & Open Interfaces

20 Risk-Based Monitoring Oracle’s Multi-System Holistic Approach
Provide continuous monitoring of study and site data Support multiple methodologies for streamlining site monitoring through targeted SDV Single global safety repository ensuring risk monitoring of subject safety Access to historical quantitative and qualitative site and investigator performance; Drive down costs leveraging Oracle’s pre-built integrations and open interfaces to enable RBM Plans Extensibility 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 paper Incorporating customer specific systems and processes via open interfaces Enabling real-time access to actionable insights for decision making through Mobility Upfront risk based trial planning via ClearTrial By leveraging existing investments and Oracle technology to drive down costs GOAL: Enable Life Sciences customers to deploy Centralized and Risk Based Monitoring Strategies Siebel CTMS Suite Integration & Open Interfaces External 3rd Party Data, Programs InForm Argus OC/RDC Life Sciences Data Hub Empirica Study Empirica Topics Risk Analysis Argus Analytics Clinical Development Analytics Customer Portal Mobile CRA Clinical Dashboards & Reports ClearTrial While ensuring data integrity, subject safety and compliance

21 Clinical Development Analytics

22 Enabling Operational Performance Management from Sites to Execs
ORACLE CLINICAL DEVELOPMENT ANALYTICS Executive Team Organizational Progress Head of Clinical Operations Departmental / Regional Progress CRA / Data Manager Study Progress Clinical Sites Site Progress

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 Office Clinical R&D Cloud

24 CDA’s Interactive Reports Provide Actionable Clinical Insight
Business Objectives/ Issues Accelerate Enrollment Is Program on target? Drill to Detail Which studies are behind? Gain Insights Which sites are slowest recruiters? Drill to Site Detail Take Action Call Site to Understand Low Enrollment 24 24

25 Event-Driven Clinical Insights via Alerts and Reports
Business Objectives/ Issues Maximize Data Quality New Site Coordinator mid-study (site turnover) Event logged on Exception Report Risk Identified Study Manager reviews exceptions daily Visit Schedule for site is updated with new site visit Take Action SDV Plan updated for study site (e.g. 100% for next 5 subjects) 25 25

26 Mobile CRA

27 Mobile CRA Vision Briefcase Support View SOP’s Annotation & Bookmarks
Device Integrations Notification & Offline support GPS/Location capture for Trip Report Native contacts listing and Calendar EDC View of Source Data available for visit Summary of Source Data Verified in Trip Report Mobile CRA EDC CDA CTMS Gamif-ication Argus Open Alerts/SaaG Voice Briefcase Briefcase Support View SOP’s Annotation & Bookmarks Site Compliance Clinical Development Analytics Site Metrics Alerts Voice Notes & Voice Translation Speech to Text for Trip Report Notes CTMS Trip Report Contacts and Site information Calendar Open Alerts & SaaG Integration with 3rd party External & Internal system Safety Serious Adverse Event review and verification 27 27

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 visits Study Alerts and Notifications Alerts 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 study Tablet-based Trip Reporting Revolutionizes trip reporting with the ability to download, complete and upload trip reports through a lightweight, intuitive role-focused app on a mobile tablet CTMS Contacts Synchronization Makes 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 CRAs Provides more efficient workflows for upfront planning, on-site execution and final closeout activities of site visits while facilitating compliance to industry guidance and best practices Study Site Check-In Captures 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 onsite Native Mobile App Provides 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.X Sourcing un-sourced Measures Enhancements of Risk-Based Monitoring Additional measures from CTMS/EDC Action Framework for supporting actions back to source systems New Monitoring Dashboards/Reports - User driven thresholds at Study, Project, Indication, TA Mobile CRA 2.0 Inline InForm SDV Single, unified interface for field monitors Automated SDV tracking and update to Trip Report Nuance Voice Recognition IAMS integration Clinical Monitoring Suite ClinOps Cloud Suite Offering New subscription-based model for CTMS / CDA / Mobile CRA offering hosted in the Oracle Cloud CTMS FP Web Services to support retrieval of protocol, site, and site visit information Capture of geo-location related to Mobile CRA CTMS FP Open UI Certification Fresh, Modern UI Browser Independence Support for Standards Mobility Support Mobile CRA 1.X Android Device Support - Phone, Phablet, Tablet 2012 2013 2014 CTMS 2012-IP Complex Trials / Trip Report Workflow Support multi-arm flexible trial design Trip Report Enhancements Reviewer/Approver fields & status New State Model New Layout / Approvals / Audit Trail views Add’l Integration Objects CDA 2.2 Enabling Comprehensive and Detailed Insight Milestone & cycle time performance management Key performance indicators & targets at multiple levels New executive and region-level dashboards Around 50 new pre-built reports and 33 new dashboard pages Mobile CRA 1.0 Guided Site Monitoring Study Progression Awareness, Streamlined Site Collaboration CTMS 2013-IP Trip Report Simplification Data Driven Trip Reports Configurable on the fly Real-time response branching Comprehensive feedback for trip report review Payment Enhancements Split payments Multiple Payees Revert payments VAT support CDA 3.0 Support for Sourcing InForm Studies InForm 4.6 or later as a transactional source DM Metrics aggregated by Region Mobile CRA 1.2 Open SaaG / Alerts Configurable Site-at-a-Glance Open Site-At-A-Glance Open Alerts CTMS 2014-x Risk-Based Monitoring SDV Plans and Policies Site Assessment - New Site Assessment fields - Support new interfaces New RBM fields (driven by TransCelerate) Integrations - InForm - ClearTrial CDA 3.1 Oracle Data Integrator (ODI) Support for ETL in addition to Informatica Move to ODI for CDA Cloud Support for ODI and Informatica on-premise Top Add’l Clinical Monitoring Suite Candidates in and into 2015 Study Risk Simulation Tool Support risk simulation and what- if scenarios providing scores by risk category based upon historical data during the upfront planning and course of a clinical trial ClinOps 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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