Electronic reporting (E2B)

Lindeq reports via EVWEB or own safety database

E-reporting in Europe

ICSRs and SUSARs have to be reported electronically (E2B) to EudraVigilance (EV).

We can provide this service via our safety database or through the EVWEB, the reporting tool provided by the EMEA.

For companies having few ICSRs/SUSARs E2B reporting may be a costly, difficult procedure. In Lindeq, we have pharmacovigilance and medical experts certified to use the EVWEB and can do this for you in a timely and cost-effective manner. We can also host your safety data in our database while you have full remote access to your data from your own computers.

If you have your own safety database and have temporarily high workload, we can enter your cases into our database and transfer them electronically EudraVigilance and to your safety database within due date of reporting. Lindeq provides an easy and cost-effective process to remain in compliance, no matter which E2B-compliant safety database you are using.

Our in-house validated safety database is web-based and fully compliant with the official ICH defined E2B standard.

Please contact us for further information.