According to the statement of the Management Board of the European Medicines Agency, the implementation of the Clinical Trials database will be delayed until 2019 due to technical difficulties.
What is a Clinical Trial?
A Clinical Trial is a study performed to investigate the safety or efficacy of a medicinal product. For human medicines, these studies are carried out on human volunteers.
A new step in the TIC
The new system will lead to a one-window application system and submission of documentation into the EU database, harmonising all the necessary procedures in a single portal for all Member States.
Who will experience the benefits of this system?
· Sponsors: A single system will reduce complexity. The system will allow the uploading of new documentation at any moment before, during and after the clinical trial and will notify sponsors about every update.
· Authorities: A better collaboration between authorities from different states and new features enabling the searches of documentation in a single place will reduce duplications and workloads and improve their efficacy.
· Users: More transparency through a unique website with all relevant information readily available
As a one of the leading regulatory centers with almost 30 years of experience, Obelis can assist you with the Clinical Trails – contact us if you have any questions and we will be happy to help you!
Victor Pastor Martin