Electronic reporting of ICSRs and SUSARs is mandatory for all marketing authorisation holders in Europe. We manage your data in our E2B compliant safety database or in your own database.
Our E2B Drug Safety Database
To fulfil your legal reporting obligations and to ensure that relevant cases are transmitted to the EMA and national competent authorities (nCAs) we offer to manage case information for your medicinal products in our drug safety database. This fully validated, E2B compliant database has several advantages:
- ICSR and SUSAR submission to the EMA and nCAs via an integrated gateway
- Case validation based on EMA business rules
- Generation of xml files for a convenient exchange of safety data, e.g. with contractual partners
- Different report formats for a variety of regions, e.g. CIOMS I and MedWatch
- Generation of tabulations for PSURs and DSURs
- Integration of a MedDRA browser for coding of adverse reactions
Our database has been established and validated by experienced professionals. So it is the perfect tool for administration and collection of all your suspected adverse reactions including entering, evaluating and archiving of all relevant information. An easy to use search function is implemented with the possibility to create different queries.