EU Clinical Trials Regulation and the Clinical Trials Information System

Be compliant with the regulation (CTR) and the system (CTIS)

Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring. It is now vitally important that stakeholder organisations, clinical trial sponsors and authorities, prepare their organization, processes and data to work with CTIS to make use of the strengths that the system and the legislation will bring.

We are now entering a three-year transition period. Failure to be ready to submit Clinical Trials Applications via CTIS by the end of January 2023 when new applications will no longer be permitted under the old Directive, will mean organisations will not be able to apply and consequently run new trials within Europe. From the end of January 2025 all clinical trials must be fully compliant with the new CTR and be created via CTIS.

Develop a transition strategy

Organisations are advised to develop a transition strategy that suits their specific needs and fits within the transition period set out by the European Commission. Furthermore, proper user management is imperative for completing all CTR activities within CTIS. Complex organisational structures and involvement of Clinical Research Organisations (CROs) may contribute to a more intricate, and potentially costly user management workload.
In order to be prepared for the stricter timelines under the CTR, organisations should evaluate their current processes and determine if and how these should be adapted to meet the newly established timelines. Additionally, considerations around timelines may also impact the chosen operational model, ensuring that those submitting the data and/or documentation within CTIS can do so in a timely manner.

Another important consideration for organisations is the transparency of clinical trial information under the Regulation. A redaction and deferral strategy can help define these processes further and formalise these steps within organisations, ensuring that all documents and data submitted to CTIS are reviewed, redacted and/or deferred according to new transparency requirements.

Assess the impact

Furthermore, the Regulation and CTIS introduce challenges for clinical data management, since the way of managing and submitting this information will change fundamentally. In order to address this data challenge, organisations need to assess the impact CTR/CTIS has on the completeness, quality and provision of existing data and documents. This includes the identification of new data elements and documents to be implemented as a requirement of the Regulation and the alignment with ISO IDMP and SPOR master data.
When looking from a technology and system integration standpoint, the implementation of CTIS as central place for managing clinical trial data requires organisations to revisit how systems can support processes and data flows optimally.

Three key considerations

In summary, prioritise these three key considerations:

1. Time is ticking - no more time to wait
2. Optimise internal processes and operational activities
3. Do not forget change management

Speak to our experts

We have extensive experience in supporting regulators and top pharmaceutical companies to prepare for new Life Science Regulations, and since 2014 we have been helping organisations prepare for the implementation of the Clinical Trials Regulation. We are skilled with differentiating and setting up regulatory frameworks in challenging and diverse jurisdictions. We pride ourselves in supporting organisations in defining and executing optimal strategies for CTR implementation and ensuring they are and remain responsible businesses.

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