eBook: A Complete Guide to Data Standards for Clinical Trial Data
Building on his work for the HSRAA whitepaper, and the ISPE GAMP guidelines, Arkivum’s CTO Matthew Addis has authored a new eBook: A Complete Guide to Data Standards for Clinical Trial Data.
There is a wide range of data standards that exist for managing clinical trial data, all aimed at supporting and simplifying organisations’ compliance with key regulatory frameworks established by the FDA, EMA, and MHRA.
Arkivum’s new eBook consolidates these standards and examines their impact on clinical trial data. This is particularly relevant as data becomes increasingly complex, especially with the shift from traditional paper-based records to structured digital documents and records. This eBook covers a range of topics related to data standards, from the introduction of ICH E6 (R3) to the latest updates in version 4 of the TMF Reference Model.
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Matthew Addis
Matthew is CTO and Founder of Arkivum, responsible for technical strategy. Matthew previously worked at the University of Southampton IT Innovation Centre. Over the last fifteen years, Matthew has worked with a wide range of organisations in the UK, Europe and US on solving the challenges of long-term data retention and access.
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