compliance Archives - Arkivum

Tag: compliance

Follow us on

24 Sep, 2021

Regulation EU 536/2014: A Records Manager and Archivist’s Perspective

Russell Joyce

In April 2021, the European Medicines Agency Management Board confirmed that the Clinical Trial EU Portal and Database (a key component of the Clinical Trial Information System…

13 Jul, 2021

Panel Discussion Recording: TMF Futures 2021, Good data in the age of digital transformation

Whitney Armstrong

Arkivum were delighted to host our latest webinar, where we discussed some of the key insights from our recently published TMF Futures 2021 report, ‘Good data in…

28 Jun, 2021

Arkivum report: TMF Futures 2021, Good data in the age of digital transformation

Whitney Armstrong

TMF Futures 2021: Good data in the age of digital transformation This 2021 report is drawn from our second annual TMF Futures survey. Polling the views of…

24 Jun, 2021

Webinar Recording: Practical Approaches to Digital Preservation for Life Sciences with Russell Joyce and Matthew Addis

Whitney Armstrong

Thursday 24th June 2021, 2pm BST Presented by Russell Joyce and Matthew Addis, this educational webinar examines practical approaches for the successful archiving and preservation of clinical…

20 May, 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…

19 May, 2021

Reviewing quality and completeness for Study Lock and Archival

Whitney Armstrong

The European Medicines Agency (EMA) Guidelines on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic), were finalised at the end of…