The last 12 months has seen many changes happen across the conduct of clinical trials and their subsequent inspections from regulatory authorities.
In a year that has continued to see the growth of transformation on a global scale, I wanted to take this opportunity to look back at how our industry has adapted and innovated and think about the trends I believe will be prominent over the coming months.
Clinical trials became remote
When COVID-19 began to impact the world, many industries had to reassess their operations and look at how they could adapt to remain operable. For those who weren’t already digitally prepared, the reliance placed on technology came to the forefront…immediately.
Quite simply, COVID-19 accelerated digital transformation across clinical trials. From enrolling patients, carrying out the clinical trial, storing and managing generated data and so forth.
Perhaps one of the greatest transformations was the further reliance on remote and hybrid clinical trials. We quickly saw decentralised clinical trials become the norm with many organisations having to fundamentally shift their perception of the use of technology.
Research carried out by Arkivum at the time found:
- 70% of respondents saw the pandemic as an opportunity for changing the future conduct of clinical trials.
- 75% of life sciences organisations were planning to invest significantly in technology (e.g. artificial intelligence, machine learning and cloud computing).
- 70% were looking to make a large investment in technology to enable interrogation of clinical data on a large scale.
Remote clinical trial inspections
Following the rapid adoption of remote and hybrid clinical trials came the increase in remote inspections. Just as firms had to digitally transform their operations, so too did they have to amend how they handled, recorded and store all generated data and documents.
For those holding data on a local machine or physically storing them in a filing cabinet, these records cannot be accessed and inspected by external auditors.
It’s safe to assume that these remote trends won’t be going but in order to continue moving with times, you must have the tools and technology to enable remote operations and subsequent handling of data. Having data accessible and discoverable at all times and from anywhere is the word is essential for success.
Looking to 2022
The industry will continue to require, innovate and embrace digital ways of working and the combination of decentralised clinical trials and remote inspections will simply increase the reliance on technology.
The start of a new year is always a great time to reflect and plan, asking yourself,
“Can we get all the information we need in a timely manner for anyone to review?”
“Is the data we have in a state that we can actually find what we need?”
These are great questions to begin with and to start you thinking about how prepared your organisation is for the year ahead.
Make sure you check out our other blog posts for other great questions to ask internally or feel free to get in touch with us here. We welcome the chance to speak with you about our solutions and help with any questions you may have.
For further insight and questions you should be asking of your data management strategy or external supplier, download our free Data Archiving Supplier Checklist.
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