Consolidated Clinical Trial Data Archiving and Preservation

Decentralised Archiving Putting Long-Term Data at Risk

Once a clinical trial has closed, sponsors often have a wide range of datasets spread across multiple clinical systems. This decentralised approach to archiving gives rise to data sprawl. This creates challenges such as avoiding vendor lock-in, uncontrolled costs for systems no longer in use and managing complex and diverse retention requirements. 

Additionally, this data should be accessible for as long as it is kept. Providing long-term access and use of that data can offer significant benefits to organisations. This includes supporting and facilitating mergers and acquisitions, informing future trial design and aiding resubmissions and reformulations.

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Consolidated Full Clinical Study Data Archive with Arkivum

Arkivum provides sponsors with the ability to consolidate all clinical trial records and data into a centralised long-term archive. Our solution actively safeguards and preserves data in line with retention regulations and industry good practice, such as (ALCOA+).

By consolidating all retained clinical data into a centralised repository archive, organisations can easily manage compliance requirements, reduce costs and unlock the value of long-term data.

Arkivum supports a broad range of datasets, including:

  • Electronic Case Report Forms (eCRFs)​
  • Trial Image and/or Imaging Data​
  • Raw Pre-Clinical and Clinical Data (Labs, EDC, ePRO, Wearables)​
  • Consolidated Clinical Data (SAS, SDTM, ADaM Outputs)​
  • Clinical Trial Management System (CTMS) and Randomisation (IRT/IXRS/RTSM) Data​

eTMF Archive Storage and Data Integrity

Arkivum is the only GxP-validated archiving and preservation solution. Our retention system supports clinical trial sponsors, CROs and sites to ensure that their clinical trial data is archived and preserved in line with the ALCOA+ principles.

Below are some of the key features supporting clinical sponsors. Click on the links below to find out more.

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Preservation of Clinical Trial Data

At Arkivum, we don’t just archive data; we preserve it. Recognising that the software and hardware of today may not be accessible in 25 years’, our archiving solution remains ahead of the curve, guaranteeing that your clinical data remains both available and usable for as long as required.

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Regulatory Tools to Manage Retention Requirements

Arkivum simplifies compliance. Our solution ensures your data is always inspection-ready, featuring robust audit trails and full data encryption. Managing highly regulated long-term data does not have to be difficult., Arkivum’s validated archiving and preservation solution aligns with industry regulations and guidance, ensuring the integrity of your data for as long as you need it.
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Managed Centralised Access

Manage your centralised archive and all your long-term clinical data through an easy-to-use online dashboard, which you can easily facilitate sharing amongst the team. Stay in control of your clinical study data by avoiding vendor lock- in and provide access to the right stakeholders, when they need it most. Your data will always be your data.

Partner with Arkivum

Are you from a CRO, GCP consultancy or eClinical solution provider?u003c/strongu003ernrnArkivum work with a range of partners within the clinical trial sector, supporting the application of good clinical practice. If you’re interested in collaborating with Arkivum, please explore our partner page.

Consolidated Clinical Trial Archiving FAQs

What clinical data does Arkivum support?
Can I replicate the same data structure within the Arkivum solution?
How do I access and manage the Arkivum solution?
How does the Arkivum solution support inspection readiness?
Can I view the content of my files within the archive?
Do you work directly with CROs?
What validation testing do you do?
Do you have validation documentation?
Are you certified in any ISO standards?

Interested in finding out more?

Message us via our contact us page or book some time in with one of our experienced team. We’ll arrange an initial exploratory discussion to better understand your requirements, and whether the Arkivum solution will help you solve your challenges.