NICOLA KIDMAN1, KIERAN O’DONNELL2
1.Principal Consultant, Regulatory Affairs, Arriello
2.VP of Drug Safety & Principal Consultant for Pharmacovigilance, Arriello

Abstract

Early feedback from European and US pharma companies using the EMA’s new clinical trials information system (CTIS) is remarkably positive, according to an Arriello survey. Arriello’s Kieran O’Donnell and Nicola Kidman reveal the survey findings.

In the late summer, Arriello commissioned a comprehensive survey of European and US pharma companies’ initial experiences of the EMA’s new centralized clinical trials information system (CTIS). The new platform and portal are designed to streamline the submission, assessment and approval of trials across EU markets, under the new Clinical Trials Regulation (CTR) (1), applicable since the end of January 2022 and mandatory for all new trials from January 31, 2023.

Expectations for the new system have been high - if tentative. Under previous attempts to streamline clinical trial requirements and approval processes under a European Clinical Trials Directive, too much was left to interpretation, meaning that each member state transposed the legislation slightly differently.

The August 2022 survey, conducted by Censuswide, took place at roughly the halfway point between the CTR go-live and the mandatory date for compliance with CTIS for new studies. The intention was to capture the early feedback and experiences of 400 relevant Director+/relevant Functional Heads in Pharma, Biotech and CRO companies (100 each across the UK, Germany, Sw ...