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During this session, we will discuss the true underlying issues in site regulatory management that lead directly to issues in TMF quality. Additionally, we will highlight the key costs and risks of site monitoring today, especially during the pandemic, and how there might be a simple solution to all.

Key Learnings

  • The underlying issues behind struggles with TMF completeness
  • Key issues in monitoring today, especially with necessary remote monitoring
  • Key aspects of a solution to help sites, CROs and sponsors in this process