EU CTR 536/2014: A harmonised approach to regulating clinical trials
EU CTR harmonises the management and regulation of clinical trials in the EU. This white paper summarises the key changes from the existing regulation.
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EU CTR 536/2014: A guide to support implementation
It is now imperative that sponsors determine how they will transition their operating models and clinical trials to comply with EU CTR 536/2014. This white paper discusses our recommendation for a structured approach to implementation.
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Riding the CTIS rollercoaster: What is the impact of the new transparency rules?
Following a public consultation, EMA has recently revised the EU CTR transparency rules. This paper sheds light on these revisions.
