As a global pharmaceutical company Bracco has to be comply with the rigorous quality requirements established by various regulatory bodies in areas in which it operates , such as the American Food & Drug Administration) and the European EMEA. They needed an Electronic Transmission solution to rapidly and securely interact with its regulators The solution needed to comply with The International Committee (Expert Working Group ICH M2) guidelines.
The Avanade asset, ACA Integration, was used to integrate the existing application used for clinical trials The system implemented by Avanade is an add-on to the Bracco Worldwide Adverse Event System (BWAES). BizTalk Server 2002 is used for the transmission of messages and for the execution of processes and interfaces. This allowed for the implementation of protocols like X.400 and S-MIME and for additional flexibility and adaptability to meet future demands. The transfer functions have been designed to allow the automatic retrieval of data transmission in case of failure or error. They will also allow Bracco’s technicians to monitor the transmission and intervene in case of anomalies. The solution allows also data elaboration prior to their delivery to the elaboration systems.