The innovative pharmacovigilance database
1. Internet-based system
Access via the Internet over a SSL encrypted connection allows maximum flexibility: every staff member can use the database, every site can easily be integrated, and even external employees can work from wherever they are located. Most browsers can be used: Chrome, Firefox, Safari, Internet Explorer, and—last but not least—you can even use your iPad®.
2. Developed by professionals for professionals
Right from the start, data entry personnel, coding experts, and physicians with profound pharmacovigilance knowledge were involved in the development of vigiS3®—you virtually feel it with every click.
3. Integrated workflow
The software contains a pragmatic workflow as well as a comprehensive, medically driven approval process suitable for almost all our customers’ needs without additional customization.
4. Integral document management
Any document related to a case is stored electronically—you have immediate access to the complete original documentation wherever you are.
5. Sophisticated MedDRA® browser and MedDRA® version analysis
Coding at its best: mark the verbatim, search an exact match, understand the medical concept at one glance, or display the complete hierarchy when needed. Additionally, a complete version analysis for any follow-up report is conducted automatically.
6. Central updates of dictionaries, e.g. MedDRA®
Don’t worry about the biannual MedDRA® updates or modifications to other dictionaries: updates are made automatically on the central server.
7. Signal detection and signal evaluation
Pragmatic and highly effective: the integrated signal detection tool identifies signals within seconds—and you can directly access any suspicious cases.
8. Integrated gateway
A gateway for the electronic transmission of ICSRs is integrated without additional charge.
9. Fully validated installation on a central server
vigiS3® is completely installed on a secured central server and is fully validated according to GAMP5 and 21CFR11. Integration in your company-internal IT environment is neither necessary nor requires any additional validation.
10. Start right after purchase—no customization necessary
Most of our customers use vigiS3® without any customization: All relevant features are already included in the software. You can start right away.
11. Transparent and manageable costs without hidden fees
We support you in finding the most reasonable license model that perfectly meets your needs. Our offer will tell you exactly what you need to pay—trust us, there are no hidden costs!
12. Individual solutions for MAHs of any size, for MAHs with few cases only, and for CROs
We have the perfect solution for you, regardless of the size of your pharmacovigilance department(s). We also offer a special license model for MAHs with few cases, and we provide the perfect solution for CROs where you can individually pass on your costs for any client.