Since 31 January 2023, the CTIS portal has become the only point of entry for new clinical trial authorisation applications in the European Union (EU) for human medicinal products.
Jessy, Head of the Clinical Operations Department at @Atlanstat, talks us through her experience after submitting several projects to this new portal
Jessy, what does CTIS stand for ?
Clinical Trials Information System. It is the unique European portal deployed as part of European Regulation No 536/2014 on clinical trials on medicinal products for human use (CTR for Clinical Trials Regulation). This Regulation concerns clinical trials and low-intervention clinical trials conducted in Europe.
What is the aim of setting up this European portal ?
There are a number of objectives :
- To create a favourable regulatory environment for the conduct of clinical trials in Europe, while guaranteeing a high level of safety for participants ;
- To simplify the process of submitting applications to the authorities, particularly for international trials, and to centralise applications ;
- To make Europe a more attractive place for clinical trials by encouraging the participation of as many Member States as possible ;
- Increase transparency and access to data from these trials.
Who is concerned by the use of this CTIS portal ?
This portal is intended for both industrial and academic sponsors wishing to conduct a clinical trial on medicinal products in a Member State of the European Union (EU) or the European Economic Area (EEA).
The CTIS portal also provides access and a workspace for national competent authorities and the European Commission, as well as a site accessible to the general public.
What is ATLANSTAT’s experience of using the CTIS portal ?
Like all actors in the sector, we are gradually familiarising ourselves with the use of the CTIS portal. Since 31/01/23, we have already supported the initial submission of several biotechnology companies, both French and foreign, developing medicinal products for human use that have not yet been launched on the market. We are also currently assisting an academic sponsor with an initial submission. The variety of support we have provided has given us extensive experience of the CTIS portal and strengthened our ability to adapt to any type of sponsor and to any configuration and specific features of a clinical trial on medicinal products.
What services does ATLANSTAT offer its customers for a CTIS submission?
The main contact person and the privileged actor of a submission is a Clinical Operations Project Manager. ATLANSTAT offers its customers senior project managers who are self-trained in the CTIS portal thanks to the abundance of training materials offered by the EMA. A Clinical Research Associate can also be mobilised to facilitate the management of documents provided by the centres and to act as their key point of contact.
How did ATLANSTAT prepare for the implementation of the CTIS portal?
Well before the CTIS portal came into operation, our initial drug submissions were made, as far as possible, as part of the pilot phase proposed by the ANSM to enable sponsors to compile submission dossiers that complied with CTR requirements from the beginning.
Since 31/01/2023, specific CTIS monitoring tools have been created and shared with our customers to enable close monitoring of the construction of an initial submission dossier. Regular meetings between the project developer and ATLANSTAT enable us to work together proactively, keeping an open channel of communication and anticipating any problems that may arise. Respecting deadlines remains our priority and we know how to mobilise the necessary resources to achieve this.
