regulatory Archives - Arkivum

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12 Oct, 2021

Webinar Discussion: The meaning and impact of Regulation (EU) 536/2014

Whitney Armstrong

Wednesday 27th October, 2pm BST, 9am EST We’re delighted to invite you to this month’s webinar on Wednesday 27th October at 14.00hrs (BST) in which we shall…

05 Oct, 2021

What is the TMF Reference Model?

Whitney Armstrong

The Trial Master File Reference Model (TMF reference model) was created over 10 years ago with support from the Drug Information Association (DIA) Document and Records Management…

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…

28 Jun, 2021

What options do CROs and Sponsors have for managing trial data at the end of a trial?

Russell Joyce

Long ago, the concept of outsourcing clinical studies began to trend within clinical research and today, has become a customary business strategy that is widely accepted and…

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…

08 Jun, 2021

Renewed certifications in ISO 9001 and ISO 27001

Whitney Armstrong

We are delighted to announce that we have successfully renewed our certificates in ISO 9001:2015 for quality management and in ISO 27001:2017 for our information security management…