Guides and Ebooks

Clinical trial harmonization in Europe.

An Arriello US/UK/EU survey.

A snapshot of pharma’s early experiences of EMA’s new definitive, centralized registration system.

Contrary to anecdotal evidence, the majority of Clinical & Quality leads at Pharma, Biotech and CROs are largely positive about the one-stop portal, which promises to make Europe a more attractive and cohesive market in which to conduct trials.

In August 2022, at roughly the half way point between CTR go-live and the mandatory date for compliance with CTIS for new studies, we engaged Censuswide to capture the early experiences and views of 400 relevant Director+/relevant Functional Heads in Pharma, Biotech and CRO companies (breaking down into 100 representatives per market in the UK, Germany, Switzerland, and the US).

The following report draws together the key findings, highlights emerging anomalies and areas for attention, and distils the expected benefits as development teams and their colleagues or partners proceed with the new portal and harmonized registration and approvals process as standard.

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