Clinical Trial Unit Support

Under the Institute for Clinical Trials, sits the Clinical Trials Operational Units who perform sponsor activities for studies where the role of the sponsor has been delegated to the University or where the ICT is delegated services by an external sponsor. The Institute for Clinical Trials comprises of experts in Data Management, Pharmaco and Device Vigilance, Biostatistics, Coordination, Monitoring, Legal, Quality and Regulatory support.  

In the operational units such as the CRFG site, the CTU conduct Clinical Trial Activities <insert link to CRFG services>.  

In the Trials Accelerator these experts support study planning and preparation for study delivery.  

 The Clinical Trials Operational Unit supports commercial and research partners by reviewing study designs and protocols and assisting with power calculations, identifying clinical activity requirements to better inform grant applications and estimate Study budgets. Through the Institute of Clinical Trials, partners can seek legal counsel on university contracts.  

Providing expertise on data capture, database development, outcome measurement, protocol development, and safety reporting requirements.  

The Trials Accelerator can also assist with device classification and subsequent regulatory pathway processes, preparing documentation for ethics applications, pre-submission meetings with the competent authority and regulatory submissions, data protection impact assessments and submissions to CRDO for studies that are going to be delivered in CRFG.  

<Link General Enquiry Form>