TriApex, with a comprehensive pharmacovigilance service system and various optional safety databases including TrialOS, Bioknow and Argus, can provide multi-dimensional full life cycle pharmacovigilance services. TriApex works with the sponsors to establish a standardized pharmacovigilance system and strictly control drug risks.
TriApex has built a pharmacovigilance team which has over 5 years of experienced in biologicals, chemicals and traditional Chinese medicines. The team is versed in the of domestic and international pharmacovigilance regulations and processing and submission of safety reports, and can provide the pharmacovigilance service of international multi-center clinical trials.
Service Capacities-Safety management plan (SMP) formulation
-Safety database establishment
-Processing and submission of individual case safety report (ICSR)
-Safety signal detection/ risk assessment
-Preparation of annual report (DSUR/PSUR/PBRER)
-Preparation of risk control plan (RCP) and risk management plan (RMP)
-Literature search
-Intensive monitoring
-Pharmacovigilance training and consultancy
Project ExperienceTriApex is ready to provide pharmacovigilance service involved in hot drugs such as antineoplastic, analgesic, drugs intended for the treatment of endocrine, central nervous and respiration system diseases and hot technologies such as cell therapies and gene therapies, as well as the safety assessment studies of more than 10 products. We can provide the preparation of risk control plan (RCP) and risk management plan (RMP) and work with sponsors in regulatory affairs related to drug safety. We have established a diversified safety database, formulated safety management plans and accomplished the processing and submission of more than 100 individual case safety reports (ICSR). Besides, we have accomplished the preparation of more than 10 development safety update reports (DSUR), which assured the compliance of laws and regulations. Moreover, we are also ready to conduct regular literature search/signal detection/risk assessment, and develop risk minimization measures to ensure safe drug use.
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