GxP compliance Archives - Arkivum

Tag: GxP compliance

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29 Apr, 2021

Webinar: Navigating GCP Data Compliance Requirements with Russell Joyce

Whitney Armstrong

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?

Whitney Armstrong

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?

Whitney Armstrong

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

Whitney Armstrong

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

Tom Lynam

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

Tom Lynam

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…