In accordance with harmonized standards, local laws and EU directives registration of clinical trials is to be done by the relevant competent health authority and the opinion of the Ethics Committee is to be obtained.

To meet our customer’s needs, we complete documents essential for submission to the relevant authorities and the ethics committee, fill out the application documents as well as ensure due diligence of the entire process in order to obtain the approval for the clinical trial conduct within the time frames specified by law. On behalf of the Sponsor we are responsible for the communication process with the Bioethics Committee and health authorities’ representatives, as well as the process of submission throughout a clinical trial, and last but not least mandatory reporting including, but not limited to, progress reports.