Pharmacovigilance Services
We provide professional pharmacovigilance services for users in different fields such as pharmaceutical companies and R&D organizations
Pharmacovigilance Services during Clinical Trialsstep 01Prior to Clinical Trial Approval
Establishment of the pharmacovigilance systemRisk control plan (RCP)Knowledge of non-clinical and pharmacy research information
step 02Prior to Clinical Trial Initiation
Review of trial protocol and IBReview of DMP and CRFInternal and external trainingDevelopment of a safety management plan (SMP)Pharmacovigilance system configuration and testingSafety information summary analysis plan
step 03Clinical Trial in Progress
Collection and processing of SAE reports and SUSAR submissionSafety challenge managementSAE conformance check & DMDevelopment safety update report (DSUR)
step 04Post-clinical Trial/Pre-market
Review of clinical study report (CSR)Risk management plan (RMP)Review of product labeling
Well-established Post-marketing Pharmacovigilance Service SystemSystem ConstructionPharmacovigilance system establishment, database construction, training and other consulting services, assisting in inspections/internal audits
Risk ManagementSignal detection, risk assessment, risk communication
Safety ManagementSafety management plan (SMP), pharmacovigilance system master file (PSMF)
Plan DevelopmentRisk management plan, pharmacovigilance plan, phase IV study
Case ReportHotline, feedback data, case report management, literature search
Report UpdatePharmacovigilance Annual Report, PSUR/PBRER