| The Argus safety database is a key part of the | | | | and recovery procedures whenever these services |
| Argus Safety 3.0.1 pharmacovigilance software | | | | are needed. |
| system. In a nutshell, pharmacovigilance is defined as | | | | ACCOVION, the full-service contract research |
| the monitoring of any possible adverse effects of | | | | organization that offers pharmacovigilance as a core |
| both herbal remedies and synthetic drugs as they are | | | | service, has configured the Argus database with |
| used. | | | | customized and validated rules to expedite safety |
| The digital database is used to help companies ensure | | | | reporting. This setup enables generated safety |
| compliance with global regulations regarding | | | | reports to be sent to regulatory investigators and |
| pharmacovigilance and related activities. As a | | | | central ethics committees. |
| comprehensive pharmaceutical software system, it | | | | The system covers a wide range of the most |
| supports pharmacovigilance business processes that | | | | commonly used forms, including the American FDA |
| take place in both the pre- and post-marketing | | | | MedWatch 3500A form for drugs, the VAERS form |
| phases. | | | | for vaccines, the CIOMS-I form, and many others |
| The Argus database is hosted in a data center that is | | | | utilized in European countries. |
| ISO-9001-certified, and operates according to the | | | | The standard setup in use by the Argus safety |
| security standards promulgated by FDA guidelines. By | | | | database system includes coding with current World |
| managing this data center, a pharmaceutical firm or | | | | Health Organization and MedDRA data dictionaries, as |
| laboratory may obtain maximum physical data | | | | well as older versions of these dictionaries and many |
| security as well as access to effective data backup | | | | others to meet user requirements. |