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