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
