Phase I-IV clinical trial management and implementation. To manage and execute the clinical trial project within the required time frame and reasonable budget through a well-established project management system, and to work effectively with the research center and suppliers, such as study center selection, study initiation, subject enrolment, monitoring and center closure.
Comply with ICH GCP, NMPA GCP and other regulatory requirements to ensure the progress and quality of clinical study implementation. The operations team is committed to ensuring that clinical trials are executed effectively and that R&D costs are minimized.
• Clinical trials project management and monitoring of investigational new drugs: Including phase I, II, and III clinical trials
• Clinical trials project management and monitoring of Bioequivalence
• Clinical trials management and monitoring of Post-marketing clinical