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.
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.
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.