Introducing the Arkivum Solution
Click on the '+' icons below to find out more about the range of features within the Arkivum solution, including guided demos showcasing how our system works.
Arkivum provides the only GxP validated digital preservation solution to guarantee long-term data integrity inline with ALCOA+
Our truly vendor-independent solution supports clinical trial sponsors, CROs and sites in meeting clinical and all GxP archiving requirements as outlined by the FDA. This is achieved by providing a centralised and easily manageable repository for commercially valuable digital assets.
Our online SaaS solution ensures:
- Digital records are preserved in line with FDA, EMA and MHRA regulations and guidelines.
- Achieve 100% long-term data integrity. The solution is mapped to the entirety of the FDA's ALCOA+ principles for long-term data integrity (enduring, legible etc.).
- Archived records are instantly accessible by key stakeholders.
- Avoidance of data silos and vendor lock-in - this is a vendor neutral archive.
Our experienced team supports CRO- and vendor-neutral migrations, with a straightforward & GxP validated process to ensure speed, accuracy and compliance. Get setup in days not months.
Find out more:
What type of data can I archive?
Arkivum can store a wide range of essential clinical records and data within our solution, some examples include:
- Clinical Records/Data: eTMF, eCRF data, EDC, ePRO, SAS/Statistical data, Image and Imaging data
- Lab Data: Medical device records - Raw data/ Consolidated data
- Regulatory Data: SDTM/ AdAM datasets.
- GMP/Manufacturing Data: SOPs, Equipment and Maintenance records, Production efficiency metrics
- Quality Data: QMS documentation
- Corporate Records: Patents, Training records
If you have specific types of data that you are unsure about, our experienced team is available to provide more clarity.
Why other solutions are not a 'fit for purpose' long-term archive
The Arkivum solution has been purpose-built to guarantee the long-term access and use of life sciences and pharmaceutical data. While it may be tempting to choose to continue with an existing solution or approach, this often leaves long-term data at risk and not aligned to industry regulations and guidelines as outlined by the FDA, EMA and MHRA.
In the table, we have outlined how our solution differs from these other approaches.
Migration. No Migraine.
Straightforward data migration service that you can trust
Arkivum’s end to end mapping and migration service supports customers to;
- Receive their data from their CRO
- Conduct appropriate quality checks
- Move that data into a secure digital archive
The whole service is managed by Arkivum’s migration experts, requiring minimal customer effort and reducing risk…all while ensuring thorough quality checks (e.g. for completeness) are conducted on the dataset.
This process results in customer data that is complete and inspection ready on entering the archive...and it can be completed in a matter of weeks!
IngestIQ: Migration in Minutes at Scale
IngestIQ is a powerful, self-service tool designed to automate the preparation of large datasets for archival into the Arkivum system.
Managed directly from the Arkivum dashboard, IngestIQ effortlessly generates the required metadata and hierarchy documentation, ensuring your data is ready for ingest without the need of manual preparation. With built-in data integrity checks, it verifies that files remain uncorrupted during export, providing peace of mind.
IngestIQ also adheres to a fully validated migration process, ensuring reliability and compliance every step of the way.
- Significantly reduce the level of effort required to migrate data into the Arkivum system.
- Reliable and repeatable tool to migrate data at scale.
- Replicates structure of source system within the Arkivum system.
- Safeguard and preserve new and legacy study records, in a cost-effective long-term solution. Ensure long-term compliance and alignment with ALCOA++.
- Reduce the reliance on expensive external services.
- Maintain data integrity throughout the process, and evidence complete chain of custody.