Closed ATM View - TGA2014-416
Adverse Event Reporting software and services
Canberra
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.
a) The Respondent must not have had any judicial decisions against it (excluding decisions under appeal) relating to employee entitlements and have not paid the claim.
b) The Respondent, its personnel, and any Subcontractors proposed in the Submission must not, at the Closing Time, be listed as terrorists under section 15 of the Charter of the United Nations Act 1945 (Cth).
c) The Respondent (and any Subcontractor proposed in its Submission) must not be named in the Consolidated list referred to in Regulation 40 the Charter of United Nations (Dealing with Assets) Regulations 2008 (Cth).
a) TGA would like to commence the services in Feb 2015 and complete the implementation by end of FY 2014 – 2015;
b) Respondents are advised to propose a time table, based on their experience and expertise, in a MS project schedule format. TGA is aware that the services may commence in FY 2014-2015 and may be completed after the FY 2014 – 2015.