Tag: GxP compliance
29 Apr, 2021
Webinar: Navigating GCP Data Compliance Requirements with Russell Joyce
Thursday 20th May 2021, 2pm BST The preservation of digital source data and associated study documents is a critical component of compliance with Good Clinical Practice and…
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…
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,…
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 Jul, 2020
Phlexglobal and Arkivum join forces to enable Trial Master File data compliance over its entire extended lifecycle
Phlexglobal and Arkivum join forces to enable Trial Master File data compliance over its entire extended lifecycle A newly announced technical partnership between Arkivum, recognised internationally…
