Are you aware of upcoming regulatory and clinical trial submission changes? The counter for new Clinical Trial European platform’s implementation starts running in January 2022. The new Clinical Trial Regulation (536/2014) was released in 2014, but it will only come totally into force once the CTIS goes live in January 2022.
This major change will set everything up for exclusive harmonized telematic submission in Europe. The question is whether your organization is ready or not for CTIS.
You may be asking yourself why to listen to us on this issue. The key is having been part of EMAs working group since 2017. We are proud of having advised the EMA in the development of CTIS and have also been certified as CTIS Train of trainers by EMA.
Do you want to know more about what is to come? We suggest you keep reading!
What is new regarding submission process and documentation management
- Exclusive telematic submission process through CTIS
- Presentation and communication between stakeholders: Investigation Ethics Committees, Member States and Sponsors
- Database containing all clinical trial information referred to with an EU number.
- Improvement of public data availability concerning clinical trials application and results.
CTR & CTIS scope
Clinical trials in phases I to IV, as well as low-intervention clinical trials, being them commercial or non-commercial are under the scope of the European Union CTR.
On the other hand, non-interventional studies (NIS), commercial or non-commercial, such us post authorization (PA), post marketing, post authorization safety, registries, and other epidemiologic studies, are not covered by de EU CTR and they will follow their own regulations.
After CTIS go-live in January 2022, there will be a three-year multiple phase transition period.
Clinical trial documentation is currently being recorded in EudraCT database. During the first year (2022), clinical trials can be submitted under old Directive or under new Regulation (CTR 536/2014).
During years two and three (2023 & 2024), clinical trials authorized under old system remain under that system, however new clinical trials must be submitted via CTIS.
At the end of year three, hence, at the end of December 2024, ongoing clinical trials firstly submitted to EudraCT will need to be migrated to CTIS.
Transition period strategy
Setting up a strategy to implement CTIS within your organization should be one of your first steps towards clinical trials harmonization in Europe. Fostering an early implementation, no longer after than last quarter 2021, will be for sure a winning strategy.
Thus, the question is: Are you ready for the migration of your clinical trials to CTIS? For example, if you have 200 clinical trials ongoing, expected to continue after December 2024, you will need to migrate those to CTIS. EMA’s guide for migrations will be released in 2022. As soon as we have the information from the EMA we will launch a new article regarding migrations (the amount of resources needed for migrations, timelines, etc.).
If you plan to submit a new clinical trial during 2022, and it is expected to continue after December 2024, our recommendation would be for you to submit it through CTIS in the first place. That way you will avoid complex and expensive migrations.
Think about implementing CTIS in your organization asap!
Sermes CRO has been involved in the platform’s development since the beginning of the project, as we have been part of the European Medicines Agency working group since 2017. We have also been certified as CTIS Train of trainers by EMA.
Based on our CTIS expertise, we encourage you to…
- BE THE FIRST ONE! You will be reducing your CT submission times and costs before your competition.
- CHANGE YOUR MINDSET: Remember this is a major change: all changes in people (in terms of roles, responsibilities, and training), mindset, processes and data systems are required.
- USE NEW CAPPABILITIES: CTIS implementation addresses multiple capabilities across trial planning, execution, and reporting.
A new approach to submission in Europe
EU Clinical Trial Regulation (536/2014) aims to bring a better harmonization for clinical trials submission process within Europe, together with unnecessary cost reduction, due to current existence of multiple ways of submitting documentation (being it based on each countries legislation).
The goal is to make European Union a more attractive place for clinical research. No wonder coordinated assessment for multinational clinical trials is one of the benefits CTIS will for sure bring once it is implemented. In addition, it will engender a more efficient framework for the submission and assessment of clinical trial applications within established deadlines.
Nevertheless, Member States will maintain their autonomy since there will be a coordinated submission along with a non-centralized authorization.