About Arkivum
Arkivum, a world leader in digital archiving and preservation, guarantees the past, present, and future of valuable data. Expert and meticulous in handling data and digitised assets in large volumes and multiple formats, Arkivum offers a fully managed, end-to-end service that streamlines complex workflows and regulatory processes.
Championing good practice in the long-term stewardship and governance of data, Arkivum provides its diverse and prestigious customer base with a gold-standard, cost-effective service.
The integrity, security, findability, searchability and accessibility of archived data is key, and Arkivum rigorously applies the FAIR principles to data management – Findable, Accessible, Interoperable, Reusable. Arkivum offers customers a 100% data integrity guarantee, backed by insurance. Arkivum’s specialist software and services are chosen by leading institutions and commercial organisations as they take their digital transformation to the next level. We ensure compliance with professional and regulatory standards.
Arkivum's privacy policy can be found here.
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Further Reading
eBook: ICH E6(R3): What does the new guidance say about record retention?
If you’re interested in finding out more about the new ICH E6 (R3) guidelines and how they impact the way critical GxP records need to be retained, please find out more in our eBook.
Access the guide below.
About the eBook
2024 sees the publication of the latest version of ICH E6, with the R3 (revision 3) version improving on the previous 2nd iteration (R2).
The update, initially endorsed back in 2019, aims to modernise the guidelines and equip stakeholders across the clinical trial landscape with current good practices to face the challenges presented today. As stated on the ICH website, the new guidelines seek to address:
“…the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.”
The finalised draft guidelines of ICH E6(R3) cover a broad range of topics. For the purposes of this eBook (and in the context of the Arkivum community), we have focused on extracting some of the key content related to the retention of clinical trial records and data. This includes:
- The change of terminology and it’s impact on retention
- Updated retention good practice guidance within ICH E6(R3)
- Other important considerations including the management of inventories, the use of computerised systems and more.
Blog: TMF Reference Model V4: A Data-Driven, Digital Approach to TMF
To learn more about the TMF Reference Model and its adoption within the Pharmaceutical and Life Sciences community, please follow the link to our blog below. Access the guide below.
About the Blog
Within this blog Arkivum's Nick Keppe shares his four key insights from the latest CDISC TMF survey, offering a glimpse into emerging industry trends and challenges.
With the launch of TMF Reference Model V4 on the horizon, this blog provides valuable context for the evolving TMF landscape.
Blog: A Risk Based Approach to Long Term Data Integrity of Clinical Data and The Role of CDISC Standards
If you are interested to learn more about CDISC standards and how they guide organisations in managing data through a risk-based approach, please follow the link below.
About the Blog
When taking a risk-based approach in managing long-term clinical data, what exactly is involved when it comes to long-term retention?
Arkivum’s Anthony Wells draws inspiration from Matthew Addis’s recent presentation at the CDISC and TMF Interchange earlier this year, highlighting the four essential pillars for effectively managing long-term clinical data.