Life sciences firms risk falling foul of EU regulation if they fail to improve management of trial data, report warns

15 October 2021

New European Union (EU) regulation requires life sciences companies’ data in the clinical trial master file (TMF) to remain secure, accessible, and usable for a period of 25 years.

But a survey of life science professionals by Arkivum – a University of Southampton spin-out which specialises in the digital preservation of valuable data for the life sciences industry and global scientific institutions – finds that surprisingly few are prioritizing the long-term protection of their data.

"This important new regulation comes at a time when the wave of digital transformation has been accelerated by the pandemic"Some 66% of those responding to Arkivum’s TMF Futures survey say they cannot guarantee that their eTMF archive will keep their data secure, accessible and usable for 25 years.

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