Clinical trials with investigational medicinal products-initial experiences with the new EU clinical trial regulation 536/2014 and challenges and opportunities for contract research organisations

The new authorisation procedure for clinical trials on medicinal products according to Regulation (EU) No 536/2014 (Clinical Trial Regulation - CTR) became applicable in the European Union and the European Economic Area on 31 January 2022. All involved parties communicate digitally via a specially programmed IT system, the Clinical Trial Information System (CTIS), provided by the European Medicines Agency (EMA). This article highlights the cooperation between sponsors and Contract Research Organisations (CROs) when applying the CTR and CTIS.First experiences and observed trends are described focusing on user administration in CTIS and on activities related to the protection of personal data and commercially confidential information (CCI) when clinical trials are published. Challenges for CROs are multifaceted and are discussed from different angles. For example, it is necessary for CROs to temporarily maintain a Quality Management System that serves both "systems ": clinical trials under the EU-Directive 2001/20 as well as under the CTR. CTR and CTIS offer not only new tasks for CROs; they often become advisors for sponsors on the basis of their extensive experience, for example, regarding the cooperation model between sponsors and CROs and/or the strategic model for submission of a clinical trial. The article concludes with a look into possible future sponsor outsourcing strategies.