Services Medicines Clinical Trial Regulation

Clinical Trial Regulation

The Clinical Trial Regulation (CTR) is the new EU regulation that will replace the current Clinical Trial Directive (CTD).  It went live on 31 January 2022 and will be mandatory for all new trials from 31st January 2023 with any ongoing trials needing to be transitioned by January 2025.

Clinical Trial Regulation

The 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 EMA’s 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.

Are you prepared for the new
Clinical Trials Regulation?

The EU Clinical Trials Regulation (CTR) entered into force on 31 January 2022 and will be mandatory for all new applications from 31 January 2023.

Speak to us today to make sure you are ready for the new regulation.

Contact Us

Case studies

Take a look at how we have helped some of our clients.

Client 1

Challenge

DLRC were approached by a client looking for CTR expertise to assess current procedures and processes and lead the development of a CTR implementation roadmap for their organisation.

Solution

DLRC assessed the client’s SOPs and current process and analysed gaps with CTR compliance. DLRC ran workshops with the client to enhance their understanding of the CTR and drive recommendations on implementation strategy and planning.

Outcome

The SVPs of Clinical Operations and Regulatory affairs endorsed the implementation roadmap and the client team had a vastly increased knowledge of CTR and were confident in the understanding required to fully implement updates required to operate effectively and compliantly under the CTR.

Client 2

Challenge

The client required training of staff on the new requirements brought about by the CTR and recommendations on how to begin implementation.

Solution

DLRC provided high quality training on the key changes seen from the CTR to representatives from regulatory affairs, clinical operations, clinical supply, quality, medical writing and pharmacovigilance.

Outcome

DLRC received fantastic feedback from the training sessions and the teams greatly valued the training provided. The client is now using this knowledge as the foundations for implementing required change to the operating model in order to operate under the CTR.

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