We’re proud to be a CDISC Gold Member and here’s why that matters

I’m really pleased to share that Arkivum has been recognised as a Gold Member of the Clinical Data Interchange Standards Consortium (CDISC). 

On the surface, this looks like a formal certification, and it is but behind it is something we genuinely care about: supporting the standards that make clinical research data more reliable, usable and trusted over time. 

What is CDISC? 

CDISC is a global, non-profit community that builds the shared rules and formats for clinical research data. Think of it as the group that helps sponsors, CROs, sites, regulators and tech providers agree on how to structure and exchange data, so that it can be used reliably across studies and organisations. 

These standards matter because clinical research generates vast amounts of complex data over many years. When that data follows shared standards, it becomes easier to review, submit, reuse and preserve helping research move faster and reducing risk along the way. 

What’s happening with CDISC right now? 

CDISC does a huge amount of valuable work across the clinical data landscape. Recently, we’ve seen the announcement of the TMF Standard (V1), which formalises the Trial Master File as a true digital standard, and more recently the announcement of the Investigator Site File (ISF) V1 bringing similar clarity and consistency to investigator site documentation. 

Both are good examples of how CDISC continues to evolve standards to reflect modern, digital-first clinical research supporting interoperability, inspection readiness and long-term usability of trial records. 

Why CDISC membership matters to Arkivum? 

At Arkivum, our focus is on preserving clinical records and data that must be retained, trusted and accessible for the long term. That includes assets such as TMFs, ISFs, eCTD submissions, clinical databases, imaging and other essential trial records. 

Being a CDISC Gold Member reflects our alignment with the standards that support all of this data not just how it’s created or exchanged today, but how it can be preserved, understood and relied upon many years into the future. 

What CDISC membership means for our customers? 

For our customers, this membership directly influences how we design and evolve the Arkivum solution. Being close to CDISC standards helps us continually refine how clinical records are managed within our platform. 

As standards change, so do regulatory expectations. By aligning with CDISC, we can better support customers in meeting the records and documentation requirements of global health authorities such as the FDA, EMA and MHRA, throughout the full retention lifecycle. 

A final thought 

Standards may not be the most visible part of clinical innovation, but they’re foundational. They make complex data interoperable, inspection-ready, and usable long after a study concludes. 

Being a CDISC Gold Member demonstrates Arkivum’s commitment in shaping and supporting the standards that ensure clinical records can be preserved, understood, and relied upon for decades. For our customers, this means confidence that the data they entrust to us meets evolving regulatory expectations and is always inspection-ready. 

Further Reading 

If you’re looking for guidance on how to demonstrate that your archiving system meets GxP standards, our eBook, GxP Validation: Evidencing Archiving Systems are Fit for Purpose, is a great place to start.