Clinical Trial Unit Support

Under the Institute for Clinical Trials sit 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 Institute for Clinical Trials 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 Clinical Trials Units conduct Clinical Trial Activities. In the Trials Accelerator these experts support study planning and preparation for study delivery. 

The Trials accelerator can connect and signpost commercial and research partners to the Clinical Trials Operational Units experts to support study designs and identifying clinical activity requirements. Through the Institute of Clinical Trials, partners can seek legal counsel on university contracts, 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 the Clinical Trials Operational Units.