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Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud James Streeter Senior Director Life Sciences Product Strategy HSGBU October.

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Presentation on theme: "Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud James Streeter Senior Director Life Sciences Product Strategy HSGBU October."— Presentation transcript:

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2 Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud 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 The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle. 3

4 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. |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

5 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. |5 Oracle delivers advanced transformative value for clinical R&D in a modular, integrated and scalable cloud environment and helps you: Clinical Research and Development Solutions Delivering End-to-End Value 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

6 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 6 Clinical R&D Platform : Pipeline to Patient Trial Conduct Submission/ Analysis Post- Marketing LSW CLOUD Workflow, Clinical Data Model, MDM, MDR, CDR, Analysis Plan Track Source ClearTrial Study Start-Up and Design Protocol Collaboration Trial Initiation InForm / Central Designer Data Capture & Data Mgt InForm CTMS Monitoring Cloud Argus InForm Medical Adherence Insights eTMF Medical Imaging End Point Adjudication Site Reimbursement Payments Analytics Planning Trial Initiation InForm Utilities eCTD Gateway Standards Gateway InForm Late Phase EHR (HSN) OMICS Databank CTMS Cloud/ Call Centre eCOA / MHealth InForm Molecular Analytics CDA Trial Analyzer Risk-Based Monitoring Planning and Simulation CDA Cloud Clinical Performance Benchmarks IRT Trial Supply Mgt. Forecasting Grants Forecast CROSite Quality Metrics HSN Pt Recruit Protocol Validation Third Party Study Design Tools OC RDC / TMS (Hosted) IRT (RTSM) LSH / DMW / SCE LSW Cloud CDA Study Connect Identity Access Mgt Empirica CRF Submit Patient Device M2M Networks Argus Optimized and integrated processes across the clinical development landscape Investigator Network/Portal Mobile CRA Third Party Data Sources LSW Cloud Via Integrated Technology Partners

7 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 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 Oracle ClearTrial 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 Oracle ClearTrial 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 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 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 Siebel CTMS 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 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 9 ( ( Clinical Monitoring Cloud Offering User Access SSO IDM Mobile CRA: Study awareness and streamlined site visits via mobility 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 Manage: Application Monitoring, DR, Lifecycle Clinical R&D Cloud Monitoring Cloud

10 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 10 CTMS

11 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 11 What’s New: Oracle Clinical Operations Cloud Service  Unlock the Full Value of Your Investment 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 MORE VALUE.MORE CHOICE.MORE CONFIDENCE. 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 Clinical R&D Cloud

12 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 12 We always leverage our vast CTMS collateral Leverage our industry library of CTMS requirements and 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 implementati on artifacts A large library of pre- built Siebel CTMS processes

13 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 13 Pre-built CTMS Process Flows and Accelerator Configurations Based on Leading Practices for:  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 13 CTMS Accelerators leverage industry best practices to speed time to value Each Package includes: Pre-configuration Install File High Level Design Specification Functional Requirement Design Approach Step-by-Step Installation and System Testing instructions

14 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 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 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 15 Industries: plan, perform, and track field sales and service activities Web Self-Service: empower customer self help Themes: style for familiarity or brand Open UI Customization Possibilities Customer Dashboard: View top information on a single screen

16 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 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 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 17 Use Case: How We Support Risk-Based Monitoring Following FDA, EMA, TransCelerate 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 Safety Argus/Empirica Safety Argus/Empirica EDC OC/RDC & InForm EDC OC/RDC & InForm CTMS Siebel Clinical/CDA/MCR A CTMS Siebel Clinical/CDA/MCR A Mobility Mobile CRA Mobility Mobile CRA Quality by Design (QbD) Source Data Verification (SDV) Source Data Review (SDR) SDR: quality & compliance Offsite/central monitoring Investigator quality and qualitative performance SDV SDR (protocol compliance, site processes, documentation quality) Clinical Data Analytics Risk Scores/Indicators Risk-based inspections Signal Detection Analysis Quality by Design (QbD): Risk-based trial planning and impact simulation Quality Mgt Indicators Compliance Indicators Performance indicators Predictive risk simulations Risk and Quality controls GOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies Adaptive Monitoring

18 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 18 Transcelerate & CDA Risk Category Mappings Indicator Analytical & Reporting MartsClinical Transactional Applications Category Clinical Development Analytics (CDA)Argus AnalyticsCTMS EDC Inform & OC/RDCEmpirica Argus SafetyIRT SafetyXXXXXX Investigational ProductXXXX Subject Recruitment and DiscontinuationXXX ManagementXXX General IssuesXXX Data QualityXXX CRF CompletionXXX Discrepancy ManagementXXX On-site Workload-Based TriggersXXX Essential DocumentsXX Staffing, Facilities, and SuppliesXX

19 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 19 Source Data & Systems Siebel CTMS Suite Integration & Open Interfaces External 3 rd Party Data, Programs InForm Argus OC/RDC EDC Safety Trials Management Life Sciences Data Hub Warehouse Analytics, Insight, & Content Mgmt Empirica StudyEmpirica TopicsRisk Analysis Argus AnalyticsClinical Development Analytics Access, Planning, & Collaboration Customer PortalMobile CRA Clinical Dashboards & Reports Clinical Warehouse & Data Marts Signal and Risk Management Analytics ClearTrial Mobile Planning Risk-Based Monitoring Oracle’s Multi-System Holistic Approach

20 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 20 Siebel CTMS Suite Integration & Open Interfaces External 3 rd Party Data, Programs InForm Argus OC/RDC Life Sciences Data Hub Empirica StudyEmpirica TopicsRisk Analysis Argus AnalyticsClinical Development Analytics Customer PortalMobile CRA Clinical Dashboards & Reports ClearTrial 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 GOAL: Enable Life Sciences customers to deploy Centralized and Risk Based Monitoring Strategies By leveraging existing investments and Oracle technology to drive down costs While ensuring data integrity, subject safety and compliance

21 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 21 Clinical Development Analytics

22 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 22 Enabling Operational Performance Management from Sites to Execs ORACLE CLINICAL DEVELOPMENT ANALYTICS Executive Team Head of Clinical Operations CRA / Data Manager Clinical Sites Organizational Progress Departmental / Regional Progress Study Progress Site Progress

23 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 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 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 24 Call Site to Understand Low Enrollment Which sites are slowest recruiters? Accelerate Enrollment Business Objectives/ Issues Gain Insights Take Action Drill to Site Detail Which studies are behind? Is Program on target? Drill to Detail CDA’s Interactive Reports Provide Actionable Clinical Insight

25 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 25 SDV Plan updated for study site (e.g. 100% for next 5 subjects) Study Manager reviews exceptions daily Maximize Data Quality Business Objectives/ Issues Risk Identified Take Action Visit Schedule for site is updated with new site visit Event logged on Exception Report New Site Coordinator mid-study (site turnover) Event-Driven Clinical Insights via Alerts and Reports

26 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 26 Mobile CRA

27 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 27 Mobile CRA EDC CDACTMS Gamif- ication Argus Open Alerts/Sa aG Voice Briefcase Mobile CRA Vision EDC View of Source Data available for visit Summary of Source Data Verified in Trip Report CTMS Trip Report Contacts and Site information Calendar Safety Serious Adverse Event review and verification Clinical Development Analytics Site Metrics Alerts Device Integrations Notification & Offline support GPS/Location capture for Trip Report Native contacts listing and Calendar Open Alerts & SaaG Integration with 3 rd party External & Internal system Voice Notes & Voice Translation Speech to Text for Trip Report Notes Briefcase Support View SOP’s Annotation & Bookmarks Site Compliance

28 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 28 Mobile CRA Mobilizing Clinical Trial Monitoring 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 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 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 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

29 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 29 Mobile CRA Simplifying Site Visits Native Mobile App Provides an optimum end-user experience benefiting from native capabilities of mobile devices, e.g. GPS, Contacts integration, Messaging, etc. 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 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

30 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 30 Clinical Monitoring Suite 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 FP Open UI Certification Fresh, Modern UI Browser Independence Support for Standards Mobility Support Top Add’l Clinical Monitoring Suite Candidates in 2014 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 CTMS FP Web Services to support retrieval of protocol, site, and site visit information Capture of geo-location related to Mobile CRA CTMS 2013-IP Trip Report Simplification Dat a 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 ClinOps Cloud Suite Offering New subscription-based model for CTMS / CDA / Mobile CRA offering hosted in the Oracle Cloud Mobile CRA 1.X Android Device Support - Phone, Phablet, Tablet 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 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

31 Copyright © 2014, Oracle and/or its affiliates. All rights reserved. 31


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