The Clinical Trail Regulation (CTR) aims to harmonise clinical trials conducted within the EU; this is supported with the introduction of a new system, the Clinical Trials Information System (CTIS). An additional aim of the CTR is to increase the transparency of information on EU clinical trials, which is reflected in the significant changes to data publication and availability.
DLRC Regulatory Consultancy has staff with extensive experience working under the CTD, and we are ready to support you in your transition to operating under the EU CTR. We have in-house subject matter experts on the CTR, with experience working in European Medicine Agency‘s (EMA) CTIS Business team, as well as successful experience working with a number of clients on their CTR implementation programmes. We have a complete understanding of the new requirements and what you will need to change in order to be compliant and can operate effectively under the CTR with confidence.