E2B Database
Electronic reporting of ICSRs and SUSARs is mandatory for all marketing authorisation holders in Europe. We manage your data in an E2B compliant safety database according to your company’s specifications.
To fulfil your legal reporting obligations and to ensure that reportable cases are transmitted to the EMA and national competent authorities (nCAs) we offer to manage case information for your medicinal products in an established drug safety database. This fully validated E2B compliant database has several advantages that we would be happy to help you implement:
- 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
This database has been developed and validated by experienced professionals. So it is the perfect tool for administration and collection of all your 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.
With our many years of experience, we are also happy to support you in the migration process of your collected cases into an E2B complient database.
Please do not hesitate to contact us for an individual offer.