Introduction
A new clinical trial data landscape
...of sponsors now use digital systems and processes
In recent years, the pharmaceutical and life sciences industry has undergone rapid change with COVID-19 being a catalyst for digital transformation.
Whilst the pandemic brought many great challenges, it also pushed the sector to fundamentally evolve the way in which it operates. One area of particular focus is the impact this has had upon many existing processes, such as the management of clinical trials and their associated data. This guide will focus on the long-term management and preservation of the electronic Trial Master File (eTMF) and clinical study data.
Over recent years, great strides have been taken to modernise the clinical trial process with 70% of sponsors now using digital systems and processes. Whilst there are many benefits to digitising clinical trial processes (increased efficiency, enhanced collaboration and improved trial performance) many challenges still exist in this highly regulated sector. One of the largest challenges being that sponsors are required to maintain and effectively archive the eTMF (for each clinical trial). As stipulated in Regulation EU 536/2014, this retention period is for up to - and beyond - 25 years. Many organisations still do not fully comprehend all the challenges and complexity of archiving data for this length of time and what is required to avoid data loss or corruption and file obsolescence. Much confusion still exists about the suitability of cloud storage providers (such as OneDrive, SharePoint or Dropbox) which do not constitute digital archiving and preservation.
"Much confusion still exists about the suitability of cloud storage providers (such as OneDrive, SharePoint or Dropbox) which do not constitute digital archiving and preservation."
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