Adverse Event Reporting Software and Services

The Therapeutic Goods Administration (TGA) a division of the Australian Department of Health (Health) invites suitably qualified organisations to tender for the provision of an Adverse Event Management System (AMES)

a) A commercial-off-the-shelf (COTS) product for the:

* Collection and processing of adverse event reports;
* The analysis of adverse event information to detect safety signals;
* The review of safety signals identified from adverse event data and other information sources; and
* Associated reporting requirements to support the above activities.

b) Migration of data from the legacy systems to the COTS product.