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With the new normal imposed by Covid-19, more and more companies are experiencing or expecting remote inspections. This situation poses a significant challenge with our current toolset. This session will discuss these challenges and how our toolset could evolve to better handle remote inspection which are likely to become the new norm in the future.

Topics will include:

  • Challenges in conducting inspections from a sponsor standpoint and how to make all TMF relevant information available online
  • Security and traceability challenges
  • Managing communications with inspectors
  • Providing access to information contained within non-eTMF systems
  • Facilitating navigation of eTMF artifacts and relevant information to allow inspectors to understand the “story” of the study easily
  • Improving continuous inspection readiness and the possibility of ongoing access to the eTMF by inspectors during study conduct