Consolidated Clinical Trial Data Archiving and Preservation
Decentralised Clinical Data 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 clinical trial documents and data 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, clinical trial data should be accessible for as long as it is kept. A robust clinical data archival storage that provides 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.
Consolidated Full Clinical 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 clinical 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
Clinical Data Archival Storage and Data Integrity
Arkivum is the only GxP-validated clinical data 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 when archiving clinical trial records, documents and data. Click on the links below to find out more.
Preservation of Clinical Trial Data
At Arkivum, we don’t just archive clinical 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.
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 clinical data for as long as you need it. |
Managed Centralised Access
Manage your centralised clinical data 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.
Related Content on Consolidated Clinical Trial Data Archiving
Partner with Arkivum
Are you from a CRO, GCP consultancy or eClinical solution provider? Arkivum work with a range of partners within the clinical trial sector, supporting the application of good clinical practice when archiving clinical trials. If you’re interested in collaborating with Arkivum, please explore our partner page.
Consolidated Clinical Trial Archiving FAQs
How does ALCOA+ change for archived data?
Strictly speaking, ALCOA+ doesn’t change for archived data, but how we view and align ourselves to the principles does.
For live data, ALCOA+ focuses on ensuring integrity in daily use. For archived data, your approach must shift from simply storing data to pro-active archiving and preservation to combat long-term risks (.e.g like bit rot, media decay, and system obsolescence). These risks are extremely unlikely to occur in the short term and so do not need to feed into considerations in day-to-day operations.
Take the Enduring principle as an example. While live data relies on stable, active systems, keeping archived data “intact and durable” over decades requires a different approach. You can no longer just save a file and walk away; you must actively manage its lifecycle by:
Combating Data Corruption: Implementing regular integrity checks and data-repair processes to catch and resolve background degradation.
Overcoming Obsolescence: Proactively migrating data to new long-term formats before the original hardware or software becomes extinct.
Ensuring Redundancy: Maintaining a minimum of two to three copies across different geographic locations.
What clinical data does Arkivum support?
Arkivum supports a broad range of different clinical datasets. This includes (but is not limited to):
- 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
Can I replicate the same data structure within the Arkivum solution?
Yes, it is possible to create the same structure and hierarchy of data within the Arkivum solution that is used within source clinical systems.
How do I access and manage the Arkivum solution?
The Arkivum solution is managed through an online browser-based dashboard. It supports the majority of modern browsers such as Google Chrome and Microsoft Edge.
How does the Arkivum solution support inspection readiness?
The Arkivum solution is live archive, not a locked system. This means that data can be easily accessed and searched, enabling life sciences organisations to easily make requested data available. In some instances, customers may even want to provide inspectors with a bespoke login, enabling them to review and search relevant documentation as required.
In addition to this, by maintaining all of your long-term and quality checked records and data in a single repository, customers can have peace of mind that is it both inspection prepared and inspection ready.
Can I view the content of my files within the archive?
Yes, Arkivum supports a range of common formats that can be previewed within the system.
Do you work directly with CROs?
Yes, Arkivum typically works directly with CROs as part of our migration service. Depending on the arrangement, Arkivum can work directly with your CRO partners to receive end-of-study data. As part of that process, we also quality-check all records to ensure completeness and accuracy of the files and records.
What validation testing do you do?
Arkivum conducts computer system validation (CSV) which includes testing and confirming that the Arkivum solution meets documented security requirements. Arkivum also conducts penetration testing on the solution.
Do you have validation documentation?
Where required, Arkivum provides a validation pack (which includes a requirements traceability matrix, test plan, test scripts, and validation summary report), a 21 CFR Part 11 compliance assessment, a penetration testing report, and the impact assessment for GxP Data Integrity, Confidentiality, Privacy.