| Without a reliable, complaint and practical safety data | | | | extensive scale. But the system is also applicable to |
| base, pharmacovigilance services simply wouldn't | | | | those smaller concerns, keeping in line with your |
| work in real life. Pharmacovigilance work should be an | | | | everyday business needs (including economic |
| exercise in accuracy, timeliness and compliance and | | | | considerations). This means you can access the same |
| the software the safety database uses literally | | | | level of competence and reliability those larger |
| underpins all the other work staff perform. This guide | | | | companies enjoy. Alongside its popularity due to the |
| to some key features of the ARISgTM safety | | | | scope of activities it can be successfully applied to, |
| database can help you understand what it does and | | | | there is also an appreciation within the industry of the |
| why it features so heavily in European | | | | way it handles case data. |
| pharmacovigilance work. | | | | The system is capable of automatic case distribution, |
| This safety database is web based and essentially | | | | with the user able to fully define the distribution list |
| designed specifically for pharmacovigilance services | | | | according to requirements. Case routing design allows |
| activity to gather, assess and report adverse event | | | | for them to be routed to named individuals according |
| information to the appropriate (worldwide) regulatory | | | | to the features of the case. This makes the process |
| Authorities. It allows companies to comply with the | | | | highly efficient. Additionally, the system can be |
| laws for pharmacovigilance operations and uphold the | | | | configured to work smoothly with each company's |
| principles of good pharmacovigilance work. It is used | | | | existing business processes and SOPs. There are also |
| globally as an 'industry standard' application, for | | | | the necessary warnings and alerts built into the |
| example by Johnson and Johnson (who have | | | | system operations to alert the user to every |
| pharmaceutical research facilities in Europe and the | | | | necessary facet of activities. Streamlining can make |
| USA). However, you may be surprised to learn the | | | | for more efficient operations but you may also be |
| system is flexible enough to provide support to much | | | | able to streamline expenditure too. |
| smaller companies, for example, for an intended | | | | Many small and medium enterprises outsource |
| clinical trial. | | | | pharmacovigilance work to external pharmacovigilance |
| You may be a smaller company intending to conduct | | | | companies in order to comply with the need for an |
| a clinical trial or a particular product. You may be a | | | | EU Qualified Person. Making enquiries with your |
| larger company undertaking pharmacovigilance | | | | pharmacovigilance services provider about the safety |
| operations on an internal scale. The system is | | | | database they use is very important. You need to be |
| designed with a fully configurable user-interface to be | | | | confident they use an industry standard system. You |
| able to accommodate a truly vast range of needs in | | | | may find you gain good value for your investment in |
| a practical, efficient manner. This is particularly | | | | their services by ensuring they are an experienced |
| valuable for smaller and medium sized enterprises to | | | | user with this system. If you can have the provider |
| be aware of. Of course, the larger companies will | | | | facilitate using ARISgTM, this can provide savings |
| have greater resources to commit to top quality | | | | over needing the installation and system set up within |
| processing here as their operations are on an | | | | your company. |