Looking for any pharmacovigilance associates to answer the question.
https://www.omicsonline.org/abstract/review-of-the-softwares-used-in-pharmacovigilance-and-clinical-trials
I am the first qualified Pharmacovigilance Officer in my company. Sadly, we practice only spontaneous reporting here since many of our drugs are me-too drugs, or generics, or well-established. One Pharmacovigilance activity we can do here is to make an internal database that allows us to log data pertinent to our company products. Notably, we have our own National Health Agency that collects, analyzes, processes, etc. our submitted reports.
Software is only an enabling tool in Pharmacovigilance. It should be strongly supported by SOPs and well trained PV team which would facilitate global regulatory compliance. As reported above, there are several software packages (such as @risglobal, Argus etc.) available. I am familiar with @risglobal which was found to be overall satisfactory from installation/implementation and regulatory point of view. It can be fine tuned to suit individual organisational/regulatory needs.
Vigiflow, Vigimed are two softwares that are available for this purpose. However it will be best to search the biomedical literature for case reports and other studies.
Softwares like Argus, ArisGlobal, and PvNET are used in Pharmacovigilance. VigiFlow, VigiBase were used in post marketing surveillance
VigiBase is a WHO's global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO’s international drug monitoring programme.
Uppsala Monitoring Centre (UMC) in collaboration with ‘’Swissmedic’’ has developed ‘’VigiFlow’’, a web-based ICSR management system. VigiFlow functions as a national ICSR database management system and analysis tool, through which cases are sent to UMC.
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