10 Things to Consider When Building a CTMS Business Case
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The document outlines key considerations for building a Clinical Trial Management System (CTMS) business case, including the benefits of simpler maintenance, centralized databases, and transparent financial tracking. It emphasizes the importance of integration, compliance, and robust reporting for making informed decisions and achieving scalable growth in clinical trials. The agenda includes a countdown of top considerations and a live demonstration of features related to CTMS.
10 Things to Consider When Building a CTMS Business Case
- 1. 10 Things to Consider When Building a CTMS Business Case Param Singh, Director of Clinical Trial Management Solutions Life Sciences Business Unit facebook.com/perficient twitter.com/perficient_LSlinkedin.com/company/perficient
- 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. 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. About Perficient
- 4. • 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 Perficient Profile
- 5. BUSINESS SOLUTIONS Business Intelligence Business Process Management Customer Experience and CRM Enterprise Performance Management Enterprise Resource Planning Experience Design (XD) Management Consulting TECHNOLOGY SOLUTIONS Business Integration/SOA Cloud Services Commerce Content Management Custom Application Development Education Information Management Mobile Platforms Platform Integration Portal & Social Our Solutions Expertise
- 6. Life SciencesPractices/Solutions Implementation Migration Integration Validation Consulting Upgrades Managed Services Application Development Private Cloud Hosting Application Support Sub-licensing Study Setup Services Deep Clinical and Pharmacovigilance Applications Expertise 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 / Empirica Trace 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. 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. Today’s Agenda Time (ET) Topic 11:00‐11:05 Welcome and Introduction 11:05‐11:30 Count Down of Top 10 Things to Consider When Building a CTMS Business Case 11:30‐11:45 Live Demonstration of 2 Features, Voted on by You 11:45‐12:00 Q&A
- 9. Consideration #10 Simpler Maintenance Maintain one commercial system, usually with support from the vendor, rather than multiple spreadsheets and/or home-grown databases
- 10. Consideration #10: Why? • Minimal duplicate data entry and error resolution • No confusion about the stored location or most current version • No need to maintain expertise in house; rely on vendor – Vendor supplies updates, patches and bug fixes • Hosting makes it even simpler; no need to maintain IT infrastructure
- 11. Consideration #9 Centralized Investigator Database Store past, present and future investigator information in a central location that can be queried during site selection
- 12. Consideration #9: Why? • One master record with multiple read-only “associations” – People, organizations and addresses are stored separately and then associated to one another as appropriate • Centralized maintenance = cleaner data • Can capture additional metadata from standardized dropdown lists • Easier to query
- 13. Consideration #8 Transparent Financial Tracking Monitor planned costs vs. actual spend vs. outstanding balances for investigators, sites, sponsors and vendors
- 14. Consideration #8: Why? • Investigator payments, IRB fees, vendor expenses, etc. in one place provides a comprehensive picture • Enforces business rules and SOX compliance through payment statuses that can only be updated by authorized users • Helps to identify potential cost savings and to plan better for future trials
- 15. Consideration #7 Streamlined Document Tracking Create standardized lists of documents to be collected over the course of various types of trials, and track standardized dates and other information against those lists
- 16. Consideration #7: Why? • Enforces standardization and consistency in the information gathered and the method for gathering it • Allows users to update multiple document records and/or fields simultaneously • Enables quick identification of documents that are still outstanding, expired, about to expire, etc.
- 17. Consideration #6 Increased Recruitment Visibility Track subject enrollment across studies and clinical programs against planned targets
- 18. Consideration #6: Why? • Identify high- vs. low-performing investigators • Learn which sites are experiencing the greatest number of screen failures and early terminations and why • Capture metrics on planned vs. actual recruitment • Accurately plan monitoring resources
- 19. Consideration #5 Ability to Integrate Streamline processes even further through automated interfaces with other clinical and safety systems
- 20. Consideration #5: Why? • One “source” system for each kind of clinical data • Fewer data entry/maintenance resources needed • Less data investigation and correction needed • No need to log into multiple systems to find answers • Processes are completed consistently and quickly
- 21. Consideration #4 Greater Compliance Adhere to regulatory requirements and guidelines through user access controls, enforced processes, and behind-the-scenes tracking, such as audit trails
- 22. Consideration #4: Why? • Much easier to validate and keep validated/controlled than spreadsheets • Much easier to control access: system as a whole and specific records • Fewer deviations • Greater data integrity • Smoother audits
- 23. Consideration #3 Robust Reporting Answer questions quickly and easily with ad hoc and canned reports that query one centralized database
- 24. Consideration #3: Why? • Stores historical and current data • Stores ALL clinical trial data, from subject recruitment to vendor payments to investigator information • Offers high level and detailed reporting capabilities • Provides access to real-time data, especially with integrations; no more out-dated reports
- 25. Consideration #2 Informed Decision-Making Identify trends and inconsistencies across investigators, trials and business units
- 26. Consideration #2: Why? • Real-time, comprehensive data enables nimble, smart decision-making • Identify strengths and weaknesses in PIs, vendors, and even your own organization • Identify areas of risk and put processes in place to mitigate • Make changes to current trials and plan better for future trials
- 27. Consideration #1 Scalable Growth Increase the number and size of the trials you manage with fewer additional resources
- 28. Consideration #1: Why? • No organization can afford to spend exponentially to grow exponentially • Scalable software solutions are the answer • CTMS consolidates and streamlines subject tracking, investigator payments, document tracking, financial tracking, site monitoring, and more, allowing you to manage more and larger trials with less
- 29. Top 10 Considerations 10. Simpler Maintenance 9. Centralized Investigator Database 8. Transparent Financial Tracking 7. Streamlined Document Tracking 6. Increased Recruitment Visibility 5. Ability to Integrate 4. Greater Compliance 3. Robust Reporting 2. Informed Decision-Making 1. Scalable Growth
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