Research activities of the CTU include the design, conduct and analysis of clinical trials.

The CTU is particularly valuable for investigators running interventional and multi-centre studies. Our expert staff will help with the grant application, protocol design, set-up and smooth running of the trial, data collection and statistical analysis. Our regulatory and governance oversight ensures compliance with the legal and statutory requirements of the clinical trials legislation.  

Clinical trial development and approval process

• Statistical advice for trial design and analysis
• Sample size calculation
• Assistance with seeking funding and development of grant applications
• Protocol writing or input
• Protocol peer review
• Patient information writing or review
• Assistance with the ethics committee application and responses
• Design of case report forms or questionnaires

Trial conduct and management

• Clinical trial set-up and site initiation
• Database design, validation and management
• Randomisation
• Remote data capture, data entry and quality control
• Trial management and monitoring
• Statistical analysis and reporting
• Presentations and publications

Regulatory/GCP compliance

• Risk assessment
• Assistance with trial sponsorship
• Research Ethics Committee (REC) applications
• Regulatory submissions and GCP oversight
• Pharmacovigilance reporting
• Quality assurance
• Preparation for inspection                                                                             

Getting the best from the CTU
Seek advice and support early
Allow time for deadlines
Have a clear idea of what the trial is to achieve
Don’t be afraid of constructive criticism!

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