Published on March 10, 2014
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
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
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
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.
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
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
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
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
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.
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.
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
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
PREVIOUS NEXTPREVIOUS NEXTSlide 13 Live Demo – Clinical Development Analytics
PREVIOUS NEXTPREVIOUS NEXTSlide 14 CDA and Siebel Clinical
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
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.)
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?
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
PREVIOUS NEXTPREVIOUS NEXTSlide 19 Live Demo – CDA within Siebel Clinical
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
PREVIOUS NEXTPREVIOUS NEXTSlide 21 Q&A
PREVIOUS NEXTPREVIOUS NEXTSlide 22 Closing Thank you for attending! www.biopharm.com firstname.lastname@example.org +1 877-654-0033 +44 (0) 1865 910200
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