Efficient Trial Management through Unified CTMS and Study Start-up
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The webinar discusses the benefits of unified clinical trial management systems (CTMS) and their impact on study start-up processes. It highlights the inefficiencies caused by disconnected technologies and presents a unified model that improves visibility, collaboration, and speed in clinical operations. A unified approach can streamline site selection and initiation, reducing complexity and enhancing overall trial management efficiency.
Efficient Trial Management through Unified CTMS and Study Start-up
- 1. Efficient Trial Management through Unified CTMS and Study Start-up •Webinar
- 2. 2Copyright © Veeva Systems 2018 Presented By Henry Galio, Vault CTMS Email: henry.galio@veeva.com Ashley Davidson, Vault Study Startup Email: ashley.davidson@veeva.com
- 3. 3Copyright © Veeva Systems 2018 Agenda The State of Clinical Operations Technology State of Clinical Operations When SSU and CTMS are Disconnected The Value of Unified and Best-of-Breed Q&A 1 2 3 4
- 4. The State of Clinical Operations Technology
- 5. 5Copyright © Veeva Systems 2018 Clinical Trial Process Today Study Planning and Set-Up Site Activation Monitoring and Study Management Data Management Study Closeout Document Management (TMF) Site Activation Tool eTMF Tool CTMS CTMS EDC Hundreds of Tasks > Old Technologies >Complex and Inefficient Trial Process
- 6. 6Copyright © Veeva Systems 2018 Audience Poll Challenges you face due to disconnected clinical technologies? 78% 73% 62% 54% Watch on-demand webinar to gain full insights http://go.veeva.com/ctms-ssu-xtalks
- 7. 7Copyright © Veeva Systems 2018 87% of clinical leaders taking action to unify clinical systems and processes Does your organization have an initiative underway to better integrate/unify the clinical applications in Q3? (Q6) Percent of total respondents, N=331 Industry-wide Move to A Unified Clinical Model
- 8. 8Copyright © Veeva Systems 2018 Top Drivers for Unified Clinical Operations Visibility and Oversight Faster Trials Study Quality Productivity Collaboration 77% 67% 62% 51% 49% Source: 2018 Veeva Unified Clinical Operations Survey
- 9. 9Copyright © Veeva Systems 2018 Integrated versus Unified Content Replicatio n DocumentMgmt. Study Planning Site Activation Study Closeout Data Mgmt. Site Monitoring • Disparate technologies & versions • Multiple logins & user interfaces • Disconnected data, documents, & processes • Limited visibility Integrated • One platform, one version • One login & user experience • Streamlined processes, seamless flow of data & documents • Full visibility Unified
- 10. 10Copyright © Veeva Systems 2018 The Impact of Disparate Technologies Higher Integration and Maintenance Costs Reduced Ability to Make Quick Timely Decisions Slow and Error-prone Manual Processes
- 11. Integrated versus Unified What’s the Difference?
- 12. 12Copyright © Veeva Systems 2018 Audience Poll Is your CTMS and study start-up disconnected? 38% 20% 16% 16% Watch on-demand webinar to gain full insights http://go.veeva.com/ctms-ssu-xtalks
- 13. 13Copyright © Veeva Systems 2018 Disconnected Site Selection Confirm and Qualify CMSEmail Survey Tool CTMS 10. Confirm site interest in participation 11. Send CDA to site for signature 12. Negotiate CDA changes 13. Search for existing CDA or create new 14. Review and approve internally 15. Route for signature 16. Upload fully executed CDA 17. Build feasibility questionnaire 18. Distribute to interested candidate sites 19. Review survey results 20. Track progress of site qualification 21. Update site data, if relevant, upon completed questionnaire 22. Conduct PTAV Score, Rank and Select CTMSMS Excel Email 23. Update candidate site list 24. Divide site list into tiers 25. Review scores/tiered sites internally 26. Select site(s) 27. Update selection status in CTMS 28. Notify site(s) of selection 29. Provide final site list to SSU team to begin startup activities Measure Site Performance Investigator DBCTMS 30. Conduct SIV post-startup 31. Complete visit report 32. Review/approve report 33. Track enrollment progress – planned vs. actual 34. Extract performance data from CTMS 35. Import site data into DB and other selection tools Identify Sites CTMSInvestigator DB MS Excel Email 9 Review recommended/not recommended lists with internal team 1. Log into DB 2. Extract investigator and institution data 3. Log into CTMS 4. Extract other site data 5 Import and compile all relevant data 6. Review and clean site data 7. Search/Screen for prospects 8. Create candidate site list
- 14. 14Copyright © Veeva Systems 2018 Unified Site Selection Confirm and Qualify CMSEmail Survey Tool CTMS 10. Confirm site interest in participation 11. Send CDA to site for signature 12. Negotiate CDA changes 13. Search for existing CDA or create new 14. Review and approve internally 15. Route for signature 16. Upload fully executed CDA 17. Build feasibility questionnaire 18. Distribute to interested candidate sites 19. Review survey results 20. Track progress of site qualification 21. Update site data, if relevant, upon completed questionnaire 22. Conduct PTAV Score, Rank and Select CTMSMS Excel Email 23. Update candidate site list 24. Divide site list into tiers 25. Review scores/tiered sites internally 26. Select site(s) 27. Update selection status in CTMS 28. Notify site(s) of selection 29. Provide final site list to SSU team to begin startup activities Measure Site Performance Investigator DBCTMS 30. Conduct SIV post-startup 31. Complete visit report 32. Review/approve report 33. Track enrollment progress – planned vs. actual 34. Extract performance data from CTMS 35. Import site data into DB and other selection tools Identify Sites CTMSInvestigator DB MS Excel Email 9 Review recommended/not recommended lists with internal team 1. Log into DB 2. Extract investigator and institution data 3. Log into CTMS 4. Extract other site data 5 Import and compile all relevant data 6. Review and clean site data 7. Search/Screen for prospects 8. Create candidate site list
- 15. 15Copyright © Veeva Systems 2018 Site Selection with Vault Clinical Login to Vault Once ****** Unified Experience • Streamlines site selection by 30-40% • Reduces number of systems from 8 down to 3 • Shared data, content, & workflows • Endless loop of measured site performance
- 16. 16Copyright © Veeva Systems 2018 Disconnected Site Initiation MS ExcelEmail CTMS 4. Send package to SGL reviewer 5. Review & approve package 6. Notify SSU and/or CRA/Clin Ops of approval 7. Open SSU Tracker 8. Input approved SGL date 9. Log into CTMS 10. Track GL approval date SharePoint 1. Log into SharePoint system 2. Reconcile docs vs. requirements for GL 3. Extract/download documents Site Greenlight eTMFEmail 11. Compile approved GL package with checklist 12. Send to TMF manager 13. Log into eTMF 14. Index/classify each document 15. Review each document for quality/accuracy 16. File in correct location/section MS Excel 17. Track eTMF filed date TMF Filing Email 18. Request anticipated GL date from SSU team 19. Schedule SIV with study site 20. Confirm SIV with site CTMS 21. Track scheduled SIV date 22. Track completion of pre-SIV activities 23. Retrieve approved SGL docs 24. Conduct SIV 25. Prepare/Review visit report MS Excel 27. Compile list of required pre-SIV tasks & activities 28. Track completion of pre-SIV activities 29. Track/log site training LMS 26. Provide Protocol-specific training (s) to site staffSite Initiation Visit
- 17. 17Copyright © Veeva Systems 2018 Unified Site Initiation MS ExcelEmail CTMS 4. Send package to SGL reviewer 5. Review & approve package 6. Notify SSU and/or CRA/Clin Ops of approval 7. Open SSU Tracker 8. Input approved SGL date 9. Log into CTMS 10. Track GL approval date SharePoint 1. Log into SharePoint system 2. Reconcile docs vs. requirements for GL 3. Extract/download documents Site Greenlight eTMFEmail 11. Compile approved GL package with checklist 12. Send to TMF manager 13. Log into eTMF 14. Index/classify each document 15. Review each document for quality/accuracy 16. File in correct location/section MS Excel 17. Track eTMF filed date TMF Filing Email 18. Request anticipated GL date from SSU team 19. Schedule SIV with study site 20. Confirm SIV with site CTMS 21. Track scheduled SIV date 22. Track completion of pre-SIV activities 23. Retrieve approved SGL docs 24. Conduct SIV 25. Prepare/Review visit report MS Excel 27. Compile list of required pre-SIV tasks & activities 28. Track completion of pre-SIV activities 29. Track/log site training LMS 26. Provide Protocol-specific training (s) to site staffSite Initiation Visit
- 18. 18Copyright © Veeva Systems 2018 Site Initiation with Vault Clinical Login to Vault Once ****** Unified Experience • Streamlines site greenlight and initiation by 40-45% • Reduces number of systems from 6 down to 3 • Reduction of manual steps • Visibility between start-up and conduct processes
- 19. 19Copyright © Veeva Systems 2018 Site Activation Monitor & Site Mgmt. Data Mgmt. Document Mgmt. Study Planning Study Closeout The Unified Clinical Trial Process One Unified Solution One Intuitive User Experience One Complete View
- 21. 21Copyright © Veeva Systems 2018 The Best of Both Worlds Best-of-Breed Unified Seamless user experience Rapid innovation Purpose-built functionality Complete visibility and oversight Unified data, documents, processes
- 22. 22Copyright © Veeva Systems 2018 Quality Why Unified and Best-of-Breed? InnovationVisibility CollaborationSpeed
- 23. 23Copyright © Veeva Systems 2018 Audience Poll What other capabilities would be innovative in the study start-up and trial management areas? 81% 60% 52% 52% Watch on-demand webinar to get full insights http://go.veeva.com/ctms-ssu-xtalks
- 24. Thank you