Category: Regulatory

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28 Aug, 2018

Launch of the eTMF standard unlocks easy file sharing and collaboration across the globe

Daniel Hickmore

Introduction of the TMF standard The pharmaceutical and life sciences sectors are both heavily regulated and data-rich which creates a very real problem. How do you manage…

27 Aug, 2018

GDPR: Coming to America …

Sinéad McKeown

In Europe, we are already living in a world post-GDPR where we have upgraded our technical capabilities and data processes to ensure we are operating in a…

22 May, 2018

Final blog in series: Four economic fallacies of long term data management and how to avoid the surprising cost of “doing nothing”

Daniel Hickmore

Many Research & Development (R&D) executives express the same frustration. They may have a cure for cancer, or a revolutionary pharmaceutical discovery waiting to happen, but they just cannot quite grasp it. They think they already have the data somewhere, but have difficulty in…

11 May, 2018

Arkivum brand update: why you will see a shiny new us going forward

Becks Hicks

There’s been a lot going on behind the scenes at the Arkivum headquarters over the past 6 months. Product-wise, our team has been busy implementing a single platform for all the existing and future functionality to reside on and cater to all of our markets. More information to follow soon.

28 Mar, 2018

Data Owner Beware! New Data Integrity Guidance from MHRA

Daniel Hickmore

With the new Data Integrity guidance form MHRA this March we should revisit the importance of data integrity in Research & Development (R&D) as well as more heavily regulated parts of the pharma pipeline…

31 Jan, 2018

MHRA Pharmacovigilance and Data Integrity

Becks Hicks

What Do The 2017 MHRA Pharmacovigilance Metrics Say About Data Integrity? Written by Arkivum VP Health & Life Sciences Daniel Hickmore This year’s MHRA Pharmacovigilance Inspection Metrics…