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safety.DB, adverse events management

SAFETY.DB: the service
 
REGULATIONS
 
FUNCTIONS
ae management
forms management
reports
 
other SYSTEMS
CTDMS
INKDATA Digital Pen&Paper
InfoTrials
 

FUNCTIONS

The Safety.DB system, as integrated into CTDMS information systems (or acquired independently and autonomously), includes all the functionalities useful for managing the information gathered regarding adverse events.

In addition to the basic modules for managing the Users, Access Profiles and Studies, the main functionalities of the system include in particular:

_ AE Management for entering, viewing and researching the events, and generating the relevant forms
_ Forms Management for browsing and researching generated official forms
_ Reports for generating constantly updated statistics of the events, randomization, enrollment and possible relapses

All the functionalities are highly personalized based on the specific needs of the Client.
 
ISO 9001:2008 e ISO 27001:2005 E- CRF complies with GM Servizi srl Quality Management System certified for ISO 9001:2008
and for Information Security Management System certified ISO 27001:2005
ISO 9001:2008 e ISO 27001:2005