site selection, initiation, routine monitoring and close-out visits conduct and reporting; site management; project-specific training of investigators and site teams; management of communication between sponsor and sites; monitoring of patients’ enrollment at site level; ensuring S/AE and protocol deviations proper reporting and follow up; ensuring proper accountability and reconciliation of Investigational Product(s) and clinical supplies; review of essential documents and study OSF/PMF; source data verification; participation in site audits; support of IP-REDs packages preparation, as well as regulatory and ethics committee submission packages preparation; maintenance of study- specific and corporate tracking systems at site level; facilitation of documents, records, and laboratory supplies flow between trial sites and the Central/Regional Lab/Central Reviewer; ensuring ongoing evaluation of quality at site level; ensuring compliance with ICH GCP, regulatory and PSI/Sponsor specific requirements

Patient examination, treatment, manage emergency situation.

site selection, initiation, routine monitoring and close-out visits conduct and reporting; site management; project-specific training of investigators and site teams; management of communication between sponsor and sites; monitoring of patients’ enrollment at site level; ensuring S/AE and protocol deviations proper reporting and follow up; ensuring proper accountability and reconciliation of Investigational Product(s) and clinical supplies; review of essential documents and study OSF/PMF; source data verification; participation in site audits; support of IP-REDs packages preparation, as well as regulatory and ethics committee submission packages preparation; maintenance of study- specific and corporate tracking systems at site level; facilitation of documents, records, and laboratory supplies flow between trial sites and the Central/Regional Lab/Central Reviewer; ensuring ongoing evaluation of quality at site level; ensuring compliance with ICH GCP, regulatory and PSI/Sponsor specific requirements

Patient examination, treatment, manage emergency situation.