Clinical Research Organization

Clinical Research Organization

Certification GR-QA-C-1865/17; ELOT EN ISO 9001: 2015

Regulatory affairs

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 after study protocol approval GCP certification.

Data handling

Study portal

Maintenance of database

Safety monitoring


Coordination of Safety Monitoring Board.

Monitoring of clinical data, lab data and lab samples

Available study portal

Coordination of blinded and un-blinded clinical research associates (CRAs) for study monitoring.

Interaction with Data Monitoring Committees.

Financial affairs

Auditing service