- Submissions of clinical trials phase I-IV as well as non-interventional trials
- Submissions of international trials are made by local expert teams aware of the local regulations and who works in collaboration with the international project management, responsible for the preparation of the core and essential study documents .
- The strong local competence of our subsidiaries is the main key for the success on each country level for both international and national trials, which assures high quality of submitted documents and appropriate handling of the submission and approval process
- Tracking of submission and approval status
- Response to deficiency letters
- Preparation of non-substantial and substantial amendments in collaboration with the medical writing team
- Notification to local authorities (registration and deregistration of sponsors, investigators and CRO at local authorities)
- Notification of the end of a clinical trial to EC, CA and local authorities
- Registration of Clinical Trials in EUDRA-CT and in any other national study database
