Plug & Play: Benefits of Out-of-the-Box Clinical Development Analytics (CDA) for Siebel Clinical

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Plug & Play: Benefits of Out-of-the-Box Clinical Development Analytics (CDA) for Siebel Clinical

  1. 1. PREVIOUS NEXTPREVIOUS NEXTSlide 1 Plug and Play: Benefits of Out- of-the-Box CDA for Siebel Clinical Parambir Singh Vice President, Clinical Trial Management Solutions BioPharm Systems Rohit Sharma Principal Consultant Clinical Data Warehousing and Analytics BioPharm Systems
  2. 2. PREVIOUS NEXTPREVIOUS NEXTSlide 2 Welcome & Introductions Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. • CTMS practice head since 2007 – Expertise in managing all phases and styles of clinical trials – Leads the team that implements, supports, enhances, and integrates Oracle’s Siebel Clinical solution • Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical – 30+ implementations and integrations – Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel Clinical
  3. 3. PREVIOUS NEXTPREVIOUS NEXTSlide 3 Welcome & Introductions (cont.) Rohit Sharma Principal Consultant in CDW&A practice BioPharm Systems, Inc. • 16 years of industry experience – Understanding and developing clients' business process and data warehousing needs – Architecting a technical solution that can fit seamlessly into their IT landscape • Extensive Oracle LSH and CDA experience – Worked at Oracle as the development manager for Oracle's Life Sciences Data Hub (LSH) and Clinical Development Analytics (CDA) – Multiple implementations and integrations of CDA/LSH
  4. 4. PREVIOUS NEXTPREVIOUS NEXTSlide 4 Welcome & Introductions (cont.) CTMS / CDW&A Practice Services Implementations Manage implementations of Siebel Clinical, ClearTrial, LabPas, LSH, CDA, and various accelerators. Integrations Build one- and two-way interfaces between Siebel CTMS, LSH, CDA, and other clinical and non-clinical systems. Training Develop and/or deliver standard and custom training classes and materials. Process Guidance Provide insight, advice, and solutions to specific clinical trial management, data, warehousing, and analytics issues.
  5. 5. PREVIOUS NEXTPREVIOUS NEXTSlide 5 Agenda • Industry Trends and Challenges • What is CDA? • CDA Out-of-the-Box Demo • What are the benefits of using CDA and SC together? • CDA with Siebel CTMS Demo • How can BioPharm Help • Q&A
  6. 6. PREVIOUS NEXTPREVIOUS NEXTSlide 6 Industry Trends • Significant Increase in Outsourcing of Trials – Moving from one-off interactions to partnership-based relationships • Clinical trials are becoming increasingly complex – More trials, more regulations, more regions, more resources • Accurate forecasting and real time reporting is more important than ever – Need the ability to view and report on data in different ways
  7. 7. PREVIOUS NEXTPREVIOUS NEXTSlide 7 Industry Trends • Need to address cost pressures and proactively reduce patient risks on increasingly complex clinical trials • Companies are moving to a more efficient and holistic approach to decision support to get more value from data collected • This new approach reduces overall costs and makes data available from numerous sources • As a result, organizations are able to make important decisions faster based on more accurate data
  8. 8. PREVIOUS NEXTPREVIOUS NEXTSlide 8 Reporting Challenges with Siebel Clinical • Limited number of out-of-the-box reports – Provides basic information in specific areas only – Little flexibility for end user in data displayed • Export capability nice, but requires additional manipulation – Basic data dump – Requires knowledgeable resource to display in logical or graphic fashion • New reports must be developed using BI Publisher or other reporting tool – May be time consuming, depending on the tool – Requires design, development, validation, and testing – Requires experienced development resource
  9. 9. PREVIOUS NEXTPREVIOUS NEXTSlide 9 Oracle Health Sciences Clinical Development Analytics is a comprehensive analytics solution that provides sponsors and CROs timely, fact-based insight into clinical programs to make more informed business decisions, increase R&D productivity, and develop drugs more effectively. What is Clinical Development Analytics? This slide courtesy Oracle Copyright © 2012, Oracle and/or its affiliates. All rights reserved.
  10. 10. PREVIOUS NEXTPREVIOUS NEXTSlide 10 CDA Warehouse & Analysis Engine What is Clinical Development Analytics? CDA Presentation Engine & Role-based Dashboards Such as OC / RDC, Siebel Clinical, and third party systems Clinical Development Users from Executives to Sites View progress at the organizational, regional, study or site level This slide courtesy Oracle Copyright © 2012, Oracle and/or its affiliates. All rights reserved.
  11. 11. PREVIOUS NEXTPREVIOUS NEXTSlide 11 CDA – Out-of-the-Box Content Contains over 150 pre-built reports and dashboards • Trial Management 24 pre-packaged reports –Covering Screening and Recruitment, Retention, and Document Management –Primary Data Source is Siebel Clinical • Data Management 26 pre-packaged reports –Covering both EDC and Paper processes –Primary Data Source is Oracle Clinical / Oracle Remote Data Capture
  12. 12. PREVIOUS NEXTPREVIOUS NEXTSlide 12 CDA – Out-of-the-Box Content (cont.) • Data warehouse optimized for clinical trials – Contains over 1,000 business attributes – Attributes cover performance management metrics and associated descriptive terms about clinical trial progress • # Subjects Enrolled, Study Name, Site, # eCRFs Approved, etc… • Pre-built business adapters for Clinical Applications
  13. 13. PREVIOUS NEXTPREVIOUS NEXTSlide 13 Live Demo – Clinical Development Analytics
  14. 14. PREVIOUS NEXTPREVIOUS NEXTSlide 14 CDA and Siebel Clinical
  15. 15. PREVIOUS NEXTPREVIOUS NEXTSlide 15 • Helps sponsors and CROs make more informed business decisions – Review and manage all clinical programs across the organization to make key business decisions early • Provides instant access to study and project status metrics – Accelerates study progress with better visibility into data – Easily track Study, Region, and Site Progress – Identify non-performing sites and better focus resources Benefits of Using CDA with Siebel Clinical
  16. 16. PREVIOUS NEXTPREVIOUS NEXTSlide 16 • Improves Clinical Productivity and Effectiveness – Increase effectiveness via more focused resource optimization – Reduce costs via greater site visibility, minimizing unnecessary travel expenses – Improve overall study performance by identifying non-performing sites earlier – Manage site performance and focus resources on most critical sites Benefits of Using CDA with Siebel Clinical (cont.)
  17. 17. PREVIOUS NEXTPREVIOUS NEXTSlide 17 Additional Benefits for Study Team Members • Clinical Monitor – How is enrollment progressing? – What are the most common reasons for screen failure? • Study Manager – Which documents are outstanding, preventing site readiness? – Which sites are taking the longest to return documents? – Which sites are the best and worst performers? • Program Manager – Which regions are recruiting the most sites?
  18. 18. PREVIOUS NEXTPREVIOUS NEXTSlide 18 Custom Reporting • Reports and dashboards can be quickly customized and extended to meet an organization’s unique requirements – Pick data points – Look at results and save – Add graphical displays
  19. 19. PREVIOUS NEXTPREVIOUS NEXTSlide 19 Live Demo – CDA within Siebel Clinical
  20. 20. PREVIOUS NEXTPREVIOUS NEXTSlide 20 How BioPharm Can Help • Services – Demonstrations – Analysis Workshops – Business case development and cost analysis – Requirements and design management – Best practice analysis and recommendations – Installation and configuration – Pilots and proofs of concept – Hosting – Implementation – Validation – Training – Extension development projects • Products – Access to or installation of a CDA sandbox environment – ASCEND implementation with CDA
  21. 21. PREVIOUS NEXTPREVIOUS NEXTSlide 21 Q&A
  22. 22. PREVIOUS NEXTPREVIOUS NEXTSlide 22 Closing Thank you for attending! www.biopharm.com info@biopharm.com +1 877-654-0033 +44 (0) 1865 910200

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