Description

A web based adverse event reporting system that supports the capture, management, reporting and analysis of adverse event of all medical products: from drugs to devices, from biologics to vaccines.

Our database is compliant with ICH, EMEA, FDA and EPVC rules and supports both MedDRA and WHO-Drug dictionaries.

Using the software you can generate all standard regulatory reports like:

1. CIOMS
2. Report case in XML format.
3. PSUR
   • Line Listing
   • Summary Tabulation
4. DSUR
5. MedWatch and MedDev reports
6. Signal Detection 

The database can be bought or can be used in SaaS (Software as a Service) modality too. Your company will only be charged a yearly fee for software usage.

Software Features

•          Constantly updated version

•          Hardware and software infrastructure

•          Data security and reliability

•          Service redundancy, connectivity backup

•          Daily data backup.