Shanghai Chengtai Pharmaceutical Technology Co., Ltd.
helping clients to introduce international advanced technology;overseas clinical trials, overseas registration,WHO prequalified vaccine application, etc.
PV database configuration;safety management plan (SMP) writing;periodic or Ad Hoc reporting and communication of safety information;individual case safety report (ICSR) processing;processing of AESI;writing of development safety update report (DSUR).
clinical trial site assessment; clinical trial quality control; clinical trial third party audit; standard operating procedure (SOP) design and writing
Provision of Clinical Trial Management System; Establishment, Maintenance and Submission of Database ; Testing, Maintenance and Management of Clinical Trial Management System; Real-Time Data Verification and Dynamic Management; Medical Coding (MedDRA, WHODrug, etc.); Blind Data Review; Statistical Analysis
selecting and training of study site; quality monitoring of clinical trial site; establishment and management of eTMF folder; investigational supplies and conference support; vaccine labeling and blinded packaging
IND Application; Clinical trial Protocol Design; Preparing Dossier Submitted to Ethics Committee; Application to Human Genetic Resources Office; Medical Monitoring; Statistical Analyses and CSR Writing; Filing for BLA/MAA