Running A Paperless Clinical Trial From Start to Finish

• Clinical Trial Regulation Changes
• Clinical Trial Challenges
• Myths, Apprehensions & Real Life Considerations
• Practical Tips

Clinical Trial Regulation Changes

• EMA Reflection Paper
  • Changes from sponsors that promote paperless direction
  • Need for investigative site files to be remote and auditable/available for inspection
• Electronic Source Documents / Health Records
• Europe: Moving to Virtual Systems
• FDA No Longer Requires Wet Signatures

Clinical Trial Challenges

• Too Many Vendors - Streamline site activities into a single solution
• Inefficient Reporting Methods
• Too Much Paper at the Site
• Excessive Onsite Monitoring Time
• Cumbersome Study Records Archival/Retrieval
  • Efficient use of technology can improve the process of study closeout

Myths, Apprehensions & Real Life Considerations

• Myth: Increase in training time to implement a paperless system
• Solutions: Employees experienced with online systems should be mandatory during the hiring process
• Sites facilitate 1-2 global studies before they bow out of the clinical trial space due to cost inefficiencies:
  • Paperless trials are easier to run and streamline
  • Greater participants in more studies results in more responsibility in documents - paperless systems have more organization
• Sites will be audited
  • Sites using paperless systems are more organized and efficient
    • Reports
    • All movement in the eTMF is auditable - with full trial audit
  • Paperless systems take up little space
    • Elimination of massive filing cabinets

Practical Tips

• Increase competitiveness as a site
  • Increase changes of being chosen to participate in a study by becoming digital
• Start small: Utilize CTMS
  • Increase chances of being chosen to participate in a study by becoming paperless
• Staff those who are more technologically advanced
  • Those with experience with digital systems/web-based tools will prove to be more valuable