Operations – how we conduct your trial
ANZGOG prepares a development plan with you which addresses the four stages of trial development post-Research Advisory Committee approval.
- Application for funding to pharma or grant application. Both require planning and development of a detailed proposal. ANZGOG assist with grant writing and submission including grant and pharma portal management.
- Contracting with funder.
- Protocol development to enable contract completion, PICF and trial documentation for ethics.
- Site selection and governance and start up
ANZGOG is a registered trial sponsor with the TGA and experienced in running a range of trials. We have a team of 9 staff in our Research Unit – project managers, translational sample management, quality assurance, Research Fellow for medical monitoring and study development and grant specialists.
ANZGOG has multiple operating centres available to conduct its clinical trials. Each brings different capabilities and experience to our operations. This includes overseas collaboration experience and Phase III studies up to the level of registration which can be required when working with pharma. Others are nimble and cost effective for work on Phase II studies. We continue to review our needs for operating centres looking to add centres to maximise capability and capacity.
Budget Development
This is a key area for feasibility in any research project. ANZGOG has proven its capability to conduct studies to the agreed budget and has skills within its team to prepare budgets for pharma, grants and philanthropy that have successfully been approved. We have excellent and timely legal support to facilitate legal and compliance agreements.
We are a trial sponsor registered with the TGA and experienced in running a range of trials. We have a team of 9 staff in our Research Unit – project managers, translational sample management, quality assurance, Research Fellow for medical monitoring and study development and grant specialists.
