Long-term storage of trial master data. Physical or Electronic?

By | February 14th, 2022|Bio-pharmaceutical, News|

Recent changes to the European Medicines Agency’s (EMA) guidance requires that Trial Master File (TMF) data is kept in an accessible and readable format for a minimum period of 25 years.  As such, all pharmaceutical companies have a regulatory requirement for the long-term storage of data. Whilst there remains the argument that paper records storage [...]