2022 | November / December 2022

Survey finds high levels of early adoption of EMA’s centralized clinical trials information system

by cyb2025

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.

ABOUT THE AUTHOR

Nicola Kidman is a Principal Consultant, Regulatory Affairs at Arriello and has over 20 years of EU/UK and International regulatory experience gained via positions in pharma, CROs and consultancy companies. Her expertise spans all aspects of regulatory affairs from early drug development to post marketing support, including clinical trial applications and amendments, clinical development plans, scientific advice, Orphan Drug Applications, Paediatric Investigation Plans, MAAs and life cycle maintenance support.  
Kieran O’Donnell is VP of Drug Safety & Principal Consultant for Pharmacovigilance at Arriello, a leading global provider of Regulatory, Quality, Safety/PV and Clinical advisory and managed services.

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