Clinical Research Organization
ELOT EN ISO 9001: 2015
CRO registration number: 158-C-23
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.
Financial affairs
Auditing service
Safety Monitoring
Pharmacovigilance
Coordination of Safety Monitoring Board
Monitoring of clinical data, lab data and lab samples
Coordination of blinded and un-blinded clinical research associates (CRAs) for study monitoring
Interaction with Data Monitoring Committees