SafetyDrugs is a safety database created to manage the whole cycle of Pharmacovigilance.
It is built to ensure compliance with EMA and FDA regulatory requirements and will be compliant with ICH ICSR (R3) and HL7.
It manages all Adverse Events regarding drugs, devices, vaccines, biologics, cosmetics and nutritional supplements.
It is also available a tool, SDConverter, that allows the automatic transcription of any structured PDF file.
SafetyDrugs offers a Business Intelligence package, powered by QlikView, able to perform both qualitative and quantitative data analysis.
The main features of SafetyDrugs Business Intelligence are:
- Adverse Event data warehouse
- Signal Detection
- Drill down analysis
- Customizable Line Listing
- Graphic and intuitive navigation
SafetyDrugs can be rented in SaaS (Software as a Service) procedure, and installed directly on an owned server. Accessing SafetyDrugs database via SaaS avoids your company to invest money for hardware and maintenance. Moreover, SaaS offers a disaster recovery system.
SafetyDrugs can be purchased and installed on the company server, so data can be stored physically in the firm. Server, data backup and disaster recovery should be provided by the client.
SafetyDrugs can be installed with our standard settings, or customized according to the client needs. SafetyDrugs standard configuration has been drawn following market requirements and it’s very suitable for small and medium companies. Moreover this package is provided with a 'ready to use' validation kit that allows SafetyDrugs to be operational within few days. To fulfill the necessities of our clients we can totally customize our pharmacovigilance database, in this case a Validation Kit suitable for specific user requirements will be created.
This version was especially created for those companies who have very few adverse events to deal with and therefore it doesn’t worth buying, or renting, a Pharmacovigilance software. Buying a package containing an agreed amount of cases, allows the access via web to SafetyDrugs and the load of the cases, without time limit. When the credit has ended, another package can be purchased.