Safety Document Exchange In The Global Clinical Research Environment

In recent years, a series of highly publicized product withdrawals and black box warnings given to marketed drugs has alerted the public and Congress that the FDA must give greater scrutiny to safety signals arising during drug development. As a result, the proper and timely reporting of Serious Adverse Events (SAEs) during clinical trials is under scrutiny.

The procedure for SAE reporting relies on multiple exchanges of information in a global environment, which is complicated and can increase the room for error.  And yet in this increasingly complex and regulated environment, companies continue to use traditional, non-secure methods for SAE reporting and notification: fax, email and overnight mail.