The Only Validated GCP Archiving and Preservation Solution

Data Retention: Compliance is complex. Complying doesn’t have to be.

Clinical trial sponsors face a complex regulatory landscape, especially when it comes to data retention. Regulations such as EU CTR state that your eTMF needs to be retained for 25 years or more. Data must be accessible and legible throughout that period.

And that’s before you’ve considered the long-term needs for other clinical data, such as eCRF, eCOA and ePRO.

As part of a risk-based approach it is essential that you select a GCP compliant archive and preservation solution, enabling you to maintain data integrity in line with ALCOA+ throughout the entire clinical data lifecycle. This supports compliance with regulations and guidelines such as EU CTR, FDA CFR 21 Part 11 and ICH E6 R3.

“The content of the clinical trial master file shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.

EU Regulation 536 of the European Parliament

Arkivum image

Centralised digital preservation for long-term GCP compliance

Leaving data in an eTMF solution, eClinical system or even a file sharing platform such as SharePoint is not viable long-term archiving solution. These systems are not designed to maintain data integrity for decades or longer and can leave your organisation at risk of critical inspection findings.

To guarantee data endures and remains legible, sponsors must actively maintain and preserve their data throughout the entire retention period

Archiving all long-term clinical records and data in a single repository enables:

  • Active digital safeguarding and preservation to maintain data integrity in line with ALCOA+ forever
  • Adherence to EU CTR, FDA CFR 21 Part 11 and ICH E6 R3
  • Easily search and access clinical records and data, supporting inspection readiness
  • Manage audited user access and regulatory demands
  • Cost-effective long-term solution which avoids vendor lock-in

Find out more about the Arkivum solution here

Arkivum’s team was knowledgeable, very helpful and responsive from beginning to end. We are looking forward to working with the team for subsequent eTMF archiving needs.

Arkivum image


GCP Archive Storage and Data Integrity

Arkivum is the only validated GCP archiving and preservation solution. Our retention system supports clinical trial sponsors, sites and CROs to ensure that their records and data are inspection-ready and retained in line with the ALCOA+ principles.

Below are some of the key features supporting life sciences organisations within clinical trials. Click on the links below to find out more.

Arkivum image

Preservation of Clinical Trial Records and 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’ time, our solution remains ahead of the curve, guaranteeing that your valuable GCP data remains both legible and human-readable in the future.

Arkivum image

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 EU CTR, ensuring the integrity of your data for as long as you need it.

Arkivum image

Data Migration Service

As part of Arkivum’s fully validated migration service, we collaborate directly with CROs and sponsors to ensure seamless and effective data migration, minimising disruption to our clients. Once the data is archived, automatic data integrity checks ensure that all data is complete, providing peace of mind.

eBook: A guide to preserving essential GCP records and data

Download our free guide on how and where to get started with your GCP data archiving and preservation. Includes compliance with key regulations and the long-term alignment to the ALCOA+ principles.

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. If you’re interested in collaborating with Arkivum, please explore our partner page.

eTMF and GCP Compliance FAQs

Why can’t I leave my data in an eTMF solution at the end of a study phase?
Can I archive clinical data with Arkivum?
Which eTMF solution providers does your solution support?
Does the Arkivum solution align to the TMF reference model?
Do you work directly with CROs?
How does the Arkivum solution support inspection readiness?
Does the Arkivum solution adhere to regulations such as EU CTR and the FDA CFR 21 Part 11?
Do you only archive eTMF records?
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.