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  • Ly-Mee Yu
    Ly-Mee Yu

    Associate Professor and Deputy Director Academic (Primary Care Clinical Trials Unit)

We manage high-quality trials of national and international importance and have access to networks of sites so we can deliver trials to time and on-target. Trial types include academic or commercial sponsor, international, multi-centre, multi-setting, and graduate support.

Our data management team ensure data meets regulatory requirements and is collected, integrated and available at the appropriate quality and cost. Functions include case report form design and annotation, database design, data entry, data validation, discrepancy management, medical coding, data extraction and database locking.

We have a dedicated team of research nurses who ensure studies are delivered in an effective and safe manner with the care, comfort and experience of participants as a priority. Our nurses support patients through each step of the study pathway, from identifying and recruiting to data collection. They hold a wide range of clinical skills including venepuncture, spirometry and pulse wave analysis.

Our team of medical statisticians provide high-quality statistical support to clinical trials and have a wide range of experience in design and analysis using cutting-edge statistical methods, such as complex intervention studies, adaptive design studies, and cluster trials, etc.

Our own in-house IT team develop specialist software to support our research, with intuitive and user-friendly interfaces. Sortition is a secure online clinical trials randomisation system incorporating commonly-used algorithms. PRISMS is an online system for managing staff training records and SOPs. 

Providing oversight of Quality Management System (QMS) e.g. initiation, review and maintaining of SOPs as well as ensuring compliance, preparing and hosting of regulatory inspections, risk assessment, training and development, compliance and auditing (including internal and external audits), monitoring.