
General
The era of paper-based TMFs within multinational studies should come to an end
Since 06 December 2018 the guideline on the content, management and archiving of the TMF is final and will be effective from 06 May 2019
Clinical Research Insights
Since 06 December 2018 the guideline on the content, management and archiving of the TMF is final and will be effective from 06 May 2019
The bad news is “time flies”, the good news is “you are the pilot”. Regulation (EU) 2017/745 (MDR) will apply after a transitional period. Namely,
Why do so many companies run their clinical studies like driving with the car through the fog? In no other industry can you find so