Email correspondence represents one of the greatest challenges to building a complete Trial Master File. This is a serious problem facing clinical trial sponsors, as it is difficult to capture all email correspondence and to classify it properly within the TMF.
In this session, we will discuss this problem from a compliance perspective and explore the TMF Reference Models correspondence guidance.
The session will also feature a case study from Chiesi, discussing the problems they were facing and how a pilot study using Phlexglobal Artificial Intelligence helped with eMail classification.
Tom Underhill Chief Technology Officer |
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Marisa Minetti Head of Late Phase Clinical Administration |