About
Record and report SAE reports according to ICH guideline E2B (R3)
Our safety database enables the documentation and reporting of Serious Adverse Event notifications from clinical trials and in market surveillance to EudraVigilance according to the current ICH Directive E2B (R3) and the EU Business Rules. In addition, it is possible to generate PDF reports according to CIOMS standard.
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AMEDON Safety DB Dashboard
Customizable dashboard for efficient navigation depending on the users' role within the vigilance processes.
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AMEDON Safety DB case documentation
The input mask contains all mandatory and optional input fields described in the current version of the ICH guideline E2B Revision 3 and the EU Business Rules based on it. The user is supported in the documentation by tooltips and by directly appearing notices in case of violation of the documentation rules in order to report ICH compliant.
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AMEDON Saftey DB case documentation with audit trail visualisation
Full access to all audit relevant history entries just on the same surface configurable for every user role.
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AMEDON Safety DB E2B gateway transmissions
As soon as all mandatory data points have been recorded in compliance with the rules, a complete report can be created in the system in PDF and XML format. The XML file is automatically checked with the current ICH schema by the application when it is created and can therefore be used directly for digital reporting to EudraVigilance via the AMEDON AS2 gateway.
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