Drafting of protocols and of consent forms.
Education of all principal investigators and sub-investigators for Good Clinical Practice.
Registration for EudraCT number and EudraCT protocol registration.
Coordination of submission to all study sites and central regulatory submission, for countries where this is needed.
Correspondence with regulatory bodies and protocol amendments.
Correspondence for requested amendments of submission files.
Registration at ClinicalTrials.gov after study protocol approval GCP certification.