Overall study management and execution
Provide overall study management and execution, including but not limited to feasibility study, Investigator/site selection, study start-up, subject enrollment and retention, site monitoring, site close-out within the study timeframe and budget.
Embed Risk-Based Monitoring concept such as centralized monitoring, specific risk management based on trial design and study phase, to increase the effectiveness of on-site monitoring
Pharmacovigilance (ICSR、PUSR、risk management etc.)
High quality and compliance with ICH GCP, local regulatory requirement and the relevant standards in project execution
Perfect clinical Quality Management System (cQMS),
Rich experience in clinical project management
Good cooperative relationship with the hospital