The ministerial decision reference G5A/59676/22.12.2016 concerning the application of the EU regulation 536/2014 on clinical trials of medicinal products for human use is effective in Greece as of March 22nd, 2017.
According to the new regulation, in order for a Sponsor to conduct a clinical trial in Greece, they must either have a legal entity in the country or a legal representative instead.
In order to support foreign CROs and foreign sponsors in the performance of their clinical research and regulatory projects, CORONIS developed iCOS, a new service offering to our clients the fulfillment of all clinical trial sponsorship obligations.
How does this work?
iCOS represents either your CRO or you, as a Sponsor, when performing studies in Greece without the need to establish an entity.
More specifically, iCOS offers you:
• A Scientific Officer with the necessary experience, in full-time and exclusive employment for your trials
• A number of experts and collaborators to support you in your project
• Contemporary facilities
• An archiving room to safeguard your confidential and non-confidential files
• Controlled access to the facilities
• High Availability IT Infrastructure and Systems
CORONIS-iCOS offers you the ability to select the workforce that will run your project to ensure they all meet your needs and standards. All employees working on iCOS projects are regularly trained on GCP quality management systems and all legislation updates.