Category: Blog
29 Mar, 2021
Should you build or buy your eTMF archival solution?
The build vs buy conundrum for businesses is not new when it comes to decisions around implementing new software. For drug sponsors, regulatory requirements to manage the…
03 Mar, 2021
When is the right time to archive your eTMF?
The archival of eTMFs has been the focus of much discussion since regulators began to increase their focus on the topic. Both the US Food and Drug…
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…
04 Dec, 2020
Open data workshop: sharing scientific research
At Arkivum, a major focus for our team is to help our customers better share their data. The requirement to share comes from many places; circulating information…
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,…
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…
