compliance Archives - Arkivum

Tag: compliance

Follow us on

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 Oct, 2020

The value in archiving eTMFs beyond compliance requirements

Tom Lynam

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…

25 Feb, 2020

What does the future hold for data management in the pharmaceutical sector?

George Waidell

What does the future hold for data management in the pharmaceutical sector? In Roman mythology, Janus was the god of beginnings, transitions, duality, and endings – he…

02 Sep, 2019

Arkivum provides pioneering e-archive to Idorsia Pharmaceuticals delivering GxP compliant long-term access to valuable product and clinical trial data

Emma Davenport

Arkivum today announced that Idorsia Pharmaceuticals, headquartered near Basel, Switzerland; has selected Arkivum to safeguard and digitally preserve their valuable research and clinical trial data. A relatively…

15 May, 2019

Webinar – Regulatory compliance for data archiving – what’s expected?

Tom Lynam

Just how difficult can it be to archive electronic data generated from a drug development project? Surely it is enough to create an “Archive” folder on a…

15 May, 2019

Webinar – Regulatory compliance for data archiving – what's expected?

Tom Lynam

Just how difficult can it be to archive electronic data generated from a drug development project? Surely it is enough to create an “Archive” folder on a…