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 ClinicalTrials.gov after study protocol approval GCP certification.
Data handling
Study portal sepsis.gr
Maintenance of database
Safety monitoring
Pharmacovigilance.
Coordination of Safety Monitoring Board.
Monitoring of clinical data, lab data and lab samples
Available study portal sepsis.gr
Coordination of blinded and un-blinded clinical research associates (CRAs) for study monitoring.
Interaction with Data Monitoring Committees.