Arkivum is delighted to announce that it has become a Gold Member of the Clinical Data Interchange Standards Consortium (CDISC). CDISC, founded in 1997, seeks to create clarity in clinical research by bringing together a global community of experts to develop and advance data standards of the highest quality.
Their standards cover several areas across the clinical research process including planning, collecting, organising, analysing and exchanging data. One such standard, which was recently welcomed into the CDISC community was the TMF Reference Model.
The model, formerly managed by the Trial Master File (TMF) Reference Model Group, was a collaboration of volunteers from across the clinical trial landscape, striving to improve the content and structure of the TMF.
Arkivum is excited to be joining such a prestigious organisation a CDISC, and is looking forward to help drive improvements of current standards within the TMF and broader clinical data management space. Arkivum also views this a great opportunity to help increase awareness and adoption of these valuable standards.
Tom Lynam, Marketing Director at Arkivum, said of the announcement ‘Data archiving is often neglected or considered too late in the process. It is my hope that by joining CDISC we can further effect thinking and approaches to long-term data management within clinical trials and ultimately have a positive impact on the sector as a whole.’
Arkivum joins a wide range of existing CDISC members from across Pharmaceutical, Biotechnology, CROs and Academic Institutions. This includes long standing members and industry stalwarts such as AbbVie, AstraZeneca, Eli Lilly, GlaxoSmithKline and Pfizer.
Arkivum is the only GxP validated digital preservation solution to guarantee long-term data integrity (ALCOA+). Our truly vendor independent solution supports clinical trial sponsors, CROs and sites in meeting clinical and all GCP archiving requirements. This is achieved by providing a centralised and easily manageable repository for commercially valuable assets (e.g. eTMF/EDC/ePRO).
Interested in speaking to Arkivum? Contact us at Hello@Arkivum.com.