Quality
These experiences provided Robyn with a valuable introduction into the current landscape in both the research/healthcare sector overall and within GenesisCare that will enable her to contribute her valuable insights to our Consumer Engagement Strategy moving forward. Additional quality improvement initiatives have included the implementation of a digital Clinical Trial Management System (CTMS). This represents a significant step forward in digital transformation of our clinical research operations. The CTMS is a relational database that enables structured, standardised, and efficient capture of clinical trial activity and performance data across the research lifecycle, improving the quality, timeliness, and reliability of information used for oversight, decision- making, and reporting. In conjunction with our electronic Investigator Site File (eISF)/ digital document management system we’ve achieved further reduction in manual handling and increased operational efficiency while strengthening data reliability.
These capabilities directly support the National Clinical Trials Governance Framework by enhancing organisational oversight, risk management, and accountability for clinical trial activity. The CTMS enables routine, near- real-time monitoring of key governance and quality indicators, including trial portfolio composition, feasibility and start-up timelines, ethics and governance approval durations, participant recruitment and retention performance, protocol deviations and serious breach reporting, safety reporting timeliness and study close-out performance. The availability of high-quality, aggregated data through the CTMS improves the efficacy of governance processes by enabling early identification of emerging risks, targeted quality improvement activities, and evidence- based resource planning. Collectively, these digital systems strengthen alignment with NCTGF principles by enabling transparent internal reporting to our leadership committees and board, and to external oversight bodies such as ethics committees, sponsors, and regulators.
In 2025, Health Service Accreditation SNAP assessments continued across multiple jurisdictions, with inspections undertaken in Queensland and Victoria. Building on assessments completed in South Australia, New South Wales, and Western Australia in 2024, our Clinical Trials program was assessed against the 27 action items outlined in the National Clinical Trials Governance Framework, completing our accreditation cycle across all our state-based services. These assessments are conducted under the authority of the Australian Commission on Safety and Quality in Health Care and form part of the National Safety and Quality Health Service (NSQHS) accreditation program. They play a vital role in reinforcing the quality, safety, and governance of the clinical trials available to our patients. The assessments confirmed a high level of alignment with the National Clinical Trials Governance Framework, recognising robust operational systems while identifying targeted opportunities for continuous improvement. At GenesisCare, we are committed to partnering with patients in everything we do. In 2025, we strengthened this commitment by working towards the goal of embedding consumer engagement across the research lifecycle, in alignment with the National Clinical Trials Governance Framework. We continued with existing avenues of consumer engagement including but not limited to: • Providing information about clinical trials and research at GenesisCare via the website • Ensuring review of patient facing trial information by consumer representatives so that the information is easy to understand • Disseminating lay summaries of results of trials to participants • Disseminating information about clinical trials to the community via social media and other media releases
These foundations were built upon by: • Establishing a presence with the GenesisCare Consumer Advisory Committee (CAC) to report on research activities and seek advice • Developing a draft Consumer Engagement Strategy (2025-2027) to create a roadmap for embedding engagement • Recruiting consumer representatives from the CAC to join a research subcommittee that will oversee further
development and execution of the Consumer Engagement Strategy.
These initiatives will enhance transparency, trust, and relevance in clinical research, ensuring that consumer voices shape trial design and delivery. The groundwork laid in 2025 positions GenesisCare to achieve full integration and sustainability of consumer engagement practices in the coming years.
Improving capacity for consumers to partner with research
The research team was thrilled to have Robyn Hughes, a valued member of the GenesisCare Consumer Advisory Committee (CAC), volunteer to join us as a consumer representative for research. A critical component in supporting consumer partnership in research in capacity building, which was a key priority in the initial stages of working together. Robyn was awarded a consumer scholarship to attend the ACTA Clinical Trials and Registries Symposium in Melbourne, supported by the research team. The symposium, hosted by the Australian Clinical Trials Alliance, focussed on advancing a self-improving healthcare system through the design and conduct of clinical trials, registries, health data, policy, regulation, and patient advocacy. Robyn also visited one of our centres, meeting the research team and seeing what research at GenesisCare looks like first-hand.
Robyn Hughes (centre) with members of the GenesisCare Victoria Research team
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