Tag: eTMF
18 Feb, 2021
New eBook: An eTMF Archiving and Preservation Guide
According to our research less than one third of sponsors think that they are archiving their eTMF in adherence to archiving regulations. The complex regulatory landscape has…
03 Feb, 2021
Infographic: TMF Futures, Keeping Data Alive
Arkivum is delighted to publish an infographic highlighting the major trends impacting the long-term management of clinical trial data for life sciences organisations. Arkivum’s inaugural TMF survey,…
09 Dec, 2020
Long-term digital archives: an accessible and accurate audit trail
Long-term digital archives for an accessible and accurate audit trail Every pharmaceutical and biotech company needs to have a robust approach and process for records management, long…
01 Dec, 2020
Managing your eTMF archive: an effective approach to digital preservation
Last year we published a post on good electronic Trial Master File (or eTMF) archiving practices and what you needed to know. Given the time that’s passed,…
06 Nov, 2020
Keeping trial data alive
In 2020, COVID-19 completely changed clinical trials in the pharmaceutical industry. We recently discussed these challenges in PharmaTimes Magazine, including how the pandemic has accelerated the crucial…
20 Oct, 2020
The value in archiving eTMFs beyond compliance requirements
All pharmaceutical companies are required to keep key GxP records (eTMF data, clinical study reports, lab notes etc) for the long term. EMA guidelines which came into…
