Safeguarding your valuable assets
When it comes to storing data for a number of years, there are many challenges your organisation has to overcome in order to protect the integrity and safeguarding of your clinical data.
Regulatory bodies across the globe have differing stipulations. However, they all require the retention of clinical trial data and documents for several years and decades. In January 2022, the EMA has made the retention requirement period of 25 years from the point of trial close.
Failure to act now could lead to:
Delays to Development
Inspection readiness requires more than data storage
Abiding by retention requirements and achieving and maintaining inspection readiness can be an ongoing and difficult challenge for any organisation.
Storing data on file-sharing sites, live systems, and offline media cannot safeguard and protect the data from untimely degradation.
Leaving your clinical data in an inappropriate system is putting it at risk from:
- Loss of data integrity.
- Data loss or corruption.
- System or vendor lock-in.
- Inaccessible data.
- Delays to drug development.
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Arkivum, a world leader in digital archiving and preservation, guarantees the past, present, and future of valuable data. Expert and meticulous in handling data and digitised assets in large volumes and multiple formats, Arkivum offers a fully managed, end-to-end service that streamlines complex workflows and regulatory processes.
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