Clinical Trial Data Archiving and Long-Term Preservation.
When a clinical trial closes, the data does not stop mattering. Sponsors can be left managing records and data such eCRFs, imaging files, EDC, ePRO, statistical outputs, and CTMS data across multiple providers and systems.
Arkivum helps sponsors to consolidate long-term clinical trial data into one validated digital archive so it remains accessible, readable and usable for as long as required.
Move completed-study data out of operational systems, reduce long-term dependency on individual vendors and maintain a clear, controlled archive that supports data integrity, inspection readiness and future reuse.
Move completed trial data out of operational systems.
Once a study is complete, keeping data distributed across multiple clinical platforms creates unnecessary complexity.
Source systems may no longer be needed operationally, suppliers can change, licences can become expensive and long-term retention requirements remain in place long after the active study has closed.
A dedicated long-term archive gives sponsors a clearer way to manage completed-study data without relying on every original application to remain available for years or decades.
One long-term archive for clinical trial records and data.
Arkivum enables sponsors to consolidate retained clinical trial data into a centralised archive, making it easier to manage, search, access and preserve information over the long term.
Clinical datasets supported by Arkivum include:
- Electronic Case Report Forms (eCRFs)
- Trial Image and/or Imaging Data
- EDC, ePRO and wearable data
- SAS, SDTM and ADaM outputs
- Clinical Trial Management System (CTMS) data
- IRT, IXRS and RTSM data
- Other completed-study records and datasets that need to remain accessible over the long term.
Arkivum works with many sponsors to archive their Trial Master File (TMF). For more information you can visit the dedicated eTMF page.
Preserve data integrity for the full retention period.
Long-term archiving is more than storing a copy of a file. Digital records can be affected by corruption, changing file formats, ageing technology and system obsolescence. Arkivum combines archiving with active digital preservation so retained clinical data can remain usable and human-readable throughout its required lifecycle.
The solution supports long-term data integrity in line with recognised good-practice principles including ALCOA+, with controls designed to safeguard content, preserve readability and maintain confidence in the retained record.
Stay inspection-ready without keeping every source system live.
A long-term archive should make retained data easier to govern, not harder to retrieve. Arkivum provides browser-based access to archived data alongside search, audit trails, encryption and controlled user access, helping organisations respond to inspection and information requests without depending on dormant operational systems.
By bringing quality-checked long-term data together in one repository, teams have a clearer view of what has been retained and where it can be found.
Validated migration from CROs and clinical systems.
Moving completed-study data into a long-term archive needs to be controlled and evidenced. Arkivum can work directly with CROs and other providers as part of the migration process, receiving end-of-study data and carrying out quality checks to support completeness and accuracy before information is retained in the archive.
Where required, Arkivum provides validation documentation including a requirements traceability matrix, test plan, testscripts and validation summary report, alongside supporting compliance and security documentation.
Keep control of your data and avoid vendor lock-in.
Retaining completed-study data in the original platform can create a long-term dependency on a system that is no longer needed for day-to-day work.
A vendor-independent archive gives organisations greater control over retained data and supports future access, reuse, migration and system retirement decisions. Data remains available through Arkivum’s online archive rather than being locked inside the application that originally created it.
Why Arkivum for clinical trial data archiving?
- GxP-validated digital archiving and preservation capability
- Active digital preservation for long-term readability and usability
- Support for a broad range of clinical trial datasets and formats
- View, query and analyse tabular clinical datasets or database exports
- Searchable, browser-based access to retained information
- Audit trails, encryption and controlled user access
- Validated migration support, including direct work with CROs where required
- ISO 9001 and ISO 27001 certified organisation
- Validation packs and supporting documentation available where required
Consolidated clinical trial archiving FAQs.
What clinical trial data can Arkivum archive?
The Arkivum solution can store and archive a broad range of completed-study datasets including eCRFs, imaging data, EDC and ePRO data, wearable data, SAS, SDTM and ADaM outputs, CTMS data and randomisation-system data.
The solution can automatically generate a preservation copy of most common files formats. Tabular files in CSV format can also be accessed, queried and analysed using our database analytics module.
Can Arkivum work directly with our CRO?
Yes. Arkivum can work directly with CRO partners as part of the migration process to receive end-of-study data and quality-check records before they are retained in the archive.
How does Arkivum support long-term data integrity?
Arkivum combines archiving with active digital preservation. This helps organisations manage data integrity risks such as file corruption and technological obsolescence while maintaining access to usable, human-readable records.
The solution has been developed in alignment with the ALCOA+ principles, to help maintain data integrity for as long as is needed.
How does the Arkivum solution support inspection readiness?
The archive keeps retained records searchable and accessible online, with audit trails and controlled access helping teams retrieve information and evidence governance when required.
What validation documentation is available?
Where required, Arkivum provides a validation pack including a requirements traceability matrix, test plan, test scripts and validation summary report, together with supporting compliance and security documentation.
What is the difference between clinical data archiving and ordinary storage?
Storage keeps files. Long-term archiving and digital preservation also address integrity, accessibility, readability,governance and technological change so records remain usable for the period they need to be retained.
