How Cloudbyz eClinical Aligns with Australia's National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework (NCTGF), established by the Australian Commission on Safety and Quality in Health Care, provides an integrated approach to ensuring that clinical trial services are aligned with high standards of safety, quality, and governance. Cloudbyz eClinical solutions, with their comprehensive features, are well-suited to meet the requirements of this framework, supporting health service organizations in achieving accreditation under the National Safety and Quality Health Service (NSQHS) Standards.

1. Governance, Leadership, and Culture

One of the core components of the NCTGF is the integration of clinical trials governance within the overall governance of health service organizations. Cloudbyz eClinical platforms, built on Salesforce's infrastructure, provide a scalable and customizable solution that enables organizations to establish robust governance frameworks. By streamlining workflows, automating trial management, and offering real-time data visibility, Cloudbyz ensures that clinical trials are conducted under well-defined governance structures that prioritize accountability, transparency, and leadership at every level. This aligns directly with the governance and leadership component, which mandates that health service organizations provide strategic direction and ensure a safety culture within clinical trial operations​.

2. Patient Safety and Quality Improvement Systems

Patient safety is at the heart of both the NCTGF and Cloudbyz's offerings. The NCTGF emphasizes the need for health service organizations to implement systems that continuously improve the safety and quality of clinical trials. Cloudbyz eClinical solutions include risk-based monitoring (RBM), real-time data collection, and automated reporting features, all of which support continuous safety monitoring and allow for proactive interventions. These capabilities align with the patient safety and quality improvement systems outlined in the framework, which focus on creating systems that improve clinical trial safety outcomes​.

3. Clinical Performance and Effectiveness

The NCTGF highlights the importance of ensuring that the clinical trial workforce is properly trained and that trials are conducted effectively. Cloudbyz eClinical solutions support this by providing integrated training management systems, ensuring compliance with Good Clinical Practice (GCP) and other relevant regulatory standards. The platform’s analytics tools also allow for continuous assessment of clinical performance, helping organizations monitor workforce efficiency and the overall effectiveness of trial operations. This aligns with the framework’s focus on clinical performance and effectiveness, ensuring that trial staff are equipped to deliver high-quality care and services​.

4. Safe Environment for the Delivery of Care

A safe environment for clinical trials is non-negotiable in the NCTGF. Cloudbyz’s secure and compliant digital infrastructure ensures that trials are conducted in a safe, regulated environment. With built-in compliance for data privacy regulations and secure communication channels, Cloudbyz eClinical platforms foster a secure digital space for all trial-related activities. This addresses the safe environment requirement of the NCTGF, ensuring that the clinical trial process maintains the highest safety standards for participants​.

5. Partnering with Consumers

The framework also emphasizes the need to partner with consumers, ensuring that patients, carers, and the community are actively involved in the clinical trial process. Cloudbyz supports patient engagement through its Participant Portal, which provides patients with real-time access to trial information, consent forms, and study updates. This feature enhances transparency and encourages patient involvement, addressing the NCTGF's Partnering with Consumers Standard.

Conclusion

In summary, Cloudbyz eClinical aligns seamlessly with the National Clinical Trials Governance Framework by integrating governance, enhancing patient safety, ensuring clinical performance, maintaining a safe environment, and promoting consumer engagement. Its powerful, flexible, and secure platforms equip health service organizations with the tools they need to meet the mandatory accreditation requirements under the NSQHS Standards while improving the overall quality of clinical trials in Australia.