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Electronic reporting of safety reports is now a legal obligation in many countries. In Europe, all safety reports have had to be communicated electronically since 5 November 2005, following the ICH (International Council for Harmonisation) standards: currently E2B(R3). With more than 22 years' experience as certified European Medicines Agency trainers for electronic transmission, we have implemented and validated database solutions for the transmission of safety reports.
Stay compliant and avoid late reporting
If your system is not E2B(R3) compliant, or the ICH and European business rules are not respected, your safety reports will be late. In the major jurisdictions of the world, late reports are considered legal non-compliance and can attract financial penalties. We help you get this right from the start.
Register with EudraVigilance and obtain the right roles
We guide you through the EudraVigilance registration process and help you obtain the necessary roles for your team.
Transmit safety reports through EV Web
We advise you on the best way to use the EMA's EV Web interface for transmitting your safety reports directly to EudraVigilance.
Apply coding and submission best practices
We work through coding and best practices for the creation and submission of safety reports, helping your team build reliable processes.
Validate your commercial software
If you choose to use commercial software instead of EV Web, we guide you through the validation process; including the formal testing required with the EMA, and auditing the validation if your system is already validated.
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