To ensure the ethical integrity of the trials, InnoWell procured the research services of The University of Sydney’s Brain and Mind Centre to provide an independent Research and Development Group (R&D Group). The R&D Group leads the Project Synergy trials, in collaboration with a wide range of mental health service providers.
In collaboration with individuals, supportive others, health professionals, and service providers, the R&D Group tests the design, usability and functionality of the Synergy Online System to ensure it is customisable to best meet the needs of specific health providers and the individuals who use their services.
From the research trials, the tested Synergy Online System will then be put within specific health services studied in a real world context. The study aims to evaluate the impact of the Synergy Online System on individual user health and social outcomes and changes in service metrics (such as reduced wait times, improved access, improved patient outcomes). The results of these real world trials will help the R+D Group to further improve the Synergy Online System.
The R&D Group is currently working in partnership with the Veterans and Veterans Families Counselling Centre, North Coast Primary Health Network headspace Services, and the Butterfly Foundation – ED HOPE, to trial the Synergy Online System. As well as testing functionality, the R&D Group will be examining the impact of the Synergy Online System in specific study areas including, culture (Indigenous and CALD); disability; and, technology-enabled suicide prevention and education.
The Synergy Online System is intended to be used for prevention, early intervention, driving clinical decision making, continuous monitoring of mental ill health and maintenance of well-being. Under Australian legislation it is considered a therapeutic good (specifically software as a medical device) and subject to the requirements of the Therapeutic Goods (Medical Devices) Regulations 2002, which is regulated by the Therapeutic Goods Administration (TGA). As such, before it can be supplied in Australia it must be entered onto the Australian Register of Therapeutic Goods (ARTG) to ensure it meets acceptable standard of safety and quality. The R&D Group ensures that evidence collected via the research trials will support in the application to the TGA to register the technology on the ARTG. Until such point as sufficient evidence has been collected (via research trials) to prove its safety and efficacy (as determined by the TGA) the Synergy Online System will be used, tested and evaluated only within clinical trials.