The ABCs of Clinical Trial Management Systems


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Gone are the days of using spreadsheets to manage clinical trials. Fortunately, a clinical trial management system (CTMS) such as Oracle Siebel CTMS, offers an effective method for streamlining business processes, reducing cost and saving time.

Whether you are a sponsor running global trials or a research organization conducting hundreds of studies, Perficient’s Param Singh, Director of Clinical Trial Management Solutions, will teach you:

What a CTMS is and who needs one
Key functions of a CTMS
CTMS selection process
System types and implementation options
Best practices

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The ABCs of Clinical Trial Management Systems

  1. 1. The ABCs of Clinical Trial Management Systems Param Singh, Director of Clinical Trial Management Solutions Life Sciences Business Unit
  2. 2. Welcome & Introduction Param Singh Director of Clinical Trial Management Solutions Life Sciences, Perficient • CTMS practice head since 2008 – Leads the team that implements, supports, enhances and integrates Oracle’s CTMS solution • Extensive Siebel CTMS implementation experience – 14+ years of experience implementing Siebel CTMS – 30+ implementations and integrations – Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel CTMS
  3. 3. About Perficient Perficient is a leading information technology consulting firm serving clients throughout North America and Europe. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities.
  4. 4. Perficient Profile • Founded in 1997 • Public, NASDAQ: PRFT • 2013 revenue ~$373 million • Major market locations throughout North America • Atlanta, Boston, Charlotte, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Los Angeles, Minneapolis, New Orleans, New York City, Northern California, Philadelphia, Southern California, St. Louis, Toronto and Washington, D.C. • Global delivery centers in China, Europe and India • >2,100 colleagues • Dedicated solution practices • ~85% repeat business rate • Alliance partnerships with major technology vendors • Multiple vendor/industry technology and growth awards
  5. 5. BUSINESS SOLUTIONS Business Intelligence Business Process Management Customer Experience and CRM Enterprise Performance Management Enterprise Resource Planning Experience Design (XD) Management Consulting Our Solutions Expertise TECHNOLOGY SOLUTIONS Business Integration/SOA Cloud Services Commerce Content Management Custom Application Development Education Information Management Mobile Platforms Platform Integration Portal & Social
  6. 6. Life Sciences Practices / Solutions Deep Clinical and Pharmacovigilance Applications Expertise Implementation Migration Integration Validation Consulting Upgrades Managed Services Application Development Private Cloud Hosting Application Support Sub-licensing Study Setup Services Clinical Trial Management Clinical Trial Planning and Budgeting Oracle ClearTrial CTMS Oracle Siebel CTMS / ASCEND Mobile CRA Clinical Data Management & Electronic Data Capture CDMS Oracle Clinical Electronic Data Capture Oracle Remote Data Capture Oracle InForm Medical Coding Oracle Thesaurus Management System Safety & Pharmacovigilance Adverse Event Reporting Oracle Argus Safety Suite Oracle AERS / EmpiricaTrace Axway Synchrony Gateway Signal Management Oracle Empirica Signal/Topics Medical Coding Oracle Thesaurus Management System Clinical Data Warehousing & Analytics Clinical Data Warehousing Oracle Life Sciences Data Hub Clinical Data Analytics Oracle Clinical Development Analytics JReview Data Review and Cleansing Oracle Data Management Workbench Clients
  7. 7. Welcome & Introductions CTMS Practice Services Implementation Manage implementations of Siebel CTMS/ASCEND and Mobile CRA Integration Build interfaces between Siebel CTMS and other clinical and safety systems Training Develop and/or deliver standard and custom training classes and materials Process Guidance Provide insight, advice and solutions for specific CTMS issues based on industry best practices
  8. 8. Today’s Agenda Time Topic 1:00‐1:05 Welcome and Introduction 1:05‐1:15 What is a CTMS and Who Needs One 1:15‐1:25 Key Functions of a CTMS 1:25‐1:30 CTMS Selection Process 1:30‐1:35 System Types & Implementation Options 1:35‐1:45 Best Practices 1:45‐2:00 Q&A
  9. 9. What is a CTMS? • Web-based technology solution that centralizes the management aspects of clinical trials • Results in streamlined business processes and reduced time and cost for most trials • Enables informed decision-making based on real-time data • Simplifies historical reporting
  10. 10. Who Needs a CTMS? • Any sponsor organization, clinical research organization or academic medical center that: – Manages multiple clinical trials on an ongoing basis – Wants to centralize and standardize the management of clinical trials and the associated business processes – Wants to reduce study start-up time and associated costs while increasing efficiencies
  11. 11. Key Functions of a CTMS • Investigator and Site Database – Cataloging the history and details of all individuals and organizations associated with clinical trials – Accelerating feasibility analyses during investigator and site selection • Study Set-Up – Tracking essential documents – Planning for study expenses – Standardizing visit and payment schedules
  12. 12. Key Functions of a CTMS • Site Management – Tracking of site budgets and investigator payments – Tracking of subject enrollment and progression – Tracking of investigational product and ancillary supplies – Tracking of protocol deviations and follow-up issues – Tracking of site visits and monitoring reports
  13. 13. Key Functions of a CTMS • Subject Tracking – Tracking overall subject enrollment – Tracking individual subject visits and activities – Tracking subject status at any time • Document Tracking – Tracking regulatory and other documents based on a study, site, individual or company – Tracking single documents or document packages
  14. 14. Key Functions of a CTMS • Financial Tracking – Monitoring expenses across a project – Tracking investigator payments based on completed activities or milestones – Tracking pass-through expenses at the site or study level • Reporting – Monitoring trip reports – Document tracking reports – Payment reports
  15. 15. Selecting a CTMS • Requirements – Organization gathers requirements from business users, IT and other stakeholders – Requirements are reviewed, finalized and prioritized • Demos – Vendor RFPs are distributed and responses received – Demos are scheduled by multiple vendors – Gap analyses are performed – Short list of best-fit systems is developed • Final Selection – Following further demos, additional requirement reviews and detailed sales discussions
  16. 16. Consideration: System Types • Standard CTMS: – Out-of-the-box system without organization-specific customizations – Shorter implementation time, but may not meet all of the organization’s requirements • CTMS Accelerator: – Pre-configured version of a standard CTMS that includes commonly-requested configurations and enhanced functionality – Can satisfy many of the organization’s key requirements without additional development – Less time and cost than a customized system
  17. 17. Consideration: System Types • Customized CTMS: – Standard or accelerator system that is tailored to organization specific configurations and/or enhancements – Implementations can be up to and over several months – Costs can be up to and over $1M, depending on the system chosen and level of customization • Costs can be reduced by starting with an accelerator
  18. 18. Consideration: Implementation Options • In-House: – Hardware and software is owned, housed and operated by the organization and maintained by its IT department • Hosted: – Hardware and software is housed and maintained off-site by a third party
  19. 19. Consideration: Hosting Options • Dedicated Hosting: – You own the software and the servers, but the servers are housed/maintained by a data center • Shared Hosting: – You own the software, but the servers are owned, housed, maintained by a data center and can be shared by others • Cloud Computing/SaaS: – You lease the use of the software and servers
  20. 20. Best Practices: Selection Process • Collect requirements from ALL stakeholders • Consider requirements beyond system functionality • Prioritize and define your evaluation scale – Consider whether you need all requirements met immediately or whether some can wait for a future phase
  21. 21. Best Practices: Implementation Strategy • “Big Bang” – All aspects of implementation completed simultaneously • Phased – Implementation is broken up into chunks, such as: Basic Installation Point Release for Custom Configurations Data Migration & Retirement of Legacy Systems Integrations
  22. 22. Best Practices: Before Implementation • Assemble your project team • Determine the tasks, deliverables, deadlines and responsible resources • Create a scope control plan • Design your communication plan • Begin your SOP gap analysis • Begin analyzing the organizational structure
  23. 23. Best Practices: During Implementation • Adhere to the project charter and the communication plan • Design your rollout plan • Design your training plan • Design your support plan • Involve users early and often • Create a “data standards” document • Mandate the use of CTMS
  24. 24. Questions?
  25. 25. Thank You! For more information, please contact: (Sales) +1 303 570 8464 (U.S. Sales) +44 (0) 1865 910200 (U.K. Sales)