Data Import

SafetyDrugs pharmacovigilance system allows direct data capture of clinical reports from XML files, in compliance with DTD 2.1 specifications. Data can be uploaded from every kind of source.

This function includes an accurate check on the incoming data.

The system checks:

• DTD specification accordance of internal file setting
• Information accuracy
• The possibility to import a double copy of the same case

If SafetyDrugs determines the non-compliance of a file with the specifications, it allows the user to open it and, eventually, complete missing data. After that, the user will be able to start again the control and import the case.

Only after the validation process and the confirmation that the case is not a double copy, the case is imported in the database.

Case numbering can be automatic (set considering the company requirements) or set by the user. The whole import process can be divided in steps executed at different times, but the most important thing is that SafetyDrugs imports only validated information.

Data Export

SafetyDrugs pharmacovigilance system manages the automatic exchange of electronic information related to an adverse event with regulatory agency (EudraVigilance) using XML file format.

The system verifies the progress of the case in the workflow, ICH compliance and DTD specifications in order to start the sending process.

The export process is easily managed and can be set according to users requirements. Each XML file can contain one or more cases, as set by the user.

Moreover, SafetyDrugs automatically warns the user about a deadline getting near and, in the worst case, even about expired deadlines.

The system keeps track of every transmission done.