Sponsors of clinical trials in the EU should be aware that the EMA’s Management Board, on 31 January 2022 established a harmonized approach to submission, assessment, and authorization of clinical trial applications as well as reporting and supervision of clinical trials with the implementation of consistent rules throughout the EU Member States. These processes are supported by an EU portal and EU database which ensure a single-entry point with a workflow with monitoring and decision-making.
This new procedure is called CTIS, and its aim is to:
- Be the single-entry point for submitting clinical trial information in the EU with the highest standards of safety for participants and increased transparency of clinical trial information.
- Support of authorities and sponsors processes throughout the life-cycle of a clinical trial through collaboration tools, workflow, and reporting and document management capabilities.
- Deliver an electronic Annual Safety Reports (ASRs) repository.
The Clinical Trials Information System (CTIS) includes three main components that fulfill the needs of its different users:
- Submission workspace
- Authority workspace
- Public website
The system also includes an Application Programming Interface (API) for the clinical trials EUPD (CTAPI) for Member States.
PVPHARM, as a leading company in specialized pharmacovigilance and clinical safety services, has a group of experts that can manage CTIS on behalf of any clinical trial sponsor, and related tasks throughout the process, as well as train and support users who have not yet had the opportunity to familiarize themselves with this system.
If you want to know more about the Clinical Trials Information System (CTIS) and its key elements, here you can review a didactic summary from the European Medicines Agency or you can also visit PVpharm’s website for further information: https://pvpharm.com/.