UCD Clinical Trials Unit

At the UCD CTU we have significant expertise of developing and designing clinical research studies. Working with investigators we have designed, developed and conducted trials across multiple specialities. We have expertise and experience in designing and conducting:

• Observational cohort studies
• Interventional trials of Investigational Medicinal Products
• Interventional trials of Medical Devices
• Diagnostic trials

We can partner with academic investigators and companies to design scientifically sound, statistically robust and regulatory compliant studies. Specific supports available include:

• Systematic Reviews and Meta analysis
• Trial Design advice
• Statistical planning
• Intervention design
• Feasibility analysis
• Cost analysis of design options
• Design of all studies from pilot to pivotal

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The trial operations team, led by Grainne O’Reilly have significant experience in the setup, conduct and close out of clinical trials. Across multiple disciplines and interventions we have a strong track record in delivering high quality trials that are routinely published in leading journals.

The trial operations team can provide support in:

• Trial documentation including PIL & Consent form
• Ethics and Regulatory Approvals
• Trial insurance
• Trial Master Files
• Site files
• Site activation
• Monitoring
• Trial Management

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The CTU supports investigators and partners with the collection of high quality, reliable data throughout their clinical research project. We have established systems and processes to ensure clinical research data is collected and managed to the highest standards.

Through our expert team we provide support with:

• Development of Case report Forms
• Building Databases
• Enabling Data Collection
• Data Completeness and Quality
• Remote Data capture
• Management of datasets
• Database lock
• Data Protection advice, including Data Protection Impact Assessments
• Randomisation
• Pharmaco- and Device vigilance

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Analysis & Reporting

Led by Dr Marie Galligan, our analysis and reporting group has significant biostatistical expertise, and enables investigator reporting to regulatory authorities, to clinical trials databases and publication of clinical trial findings in the international medical literature. Our team can provide support in the following key areas:

• Statistical Analysis Plan
• Interim Analysis
• DSUR and CSR reports
• Endpoint Analysis

Through our links to the UCD AI Healthcare Hub and INSIGHT, we have a programme for additional advanced data analysis.

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As a key component of our CTU, we have a Trial Methodology Research programme which is focused on the improvement of existing and the development of new methodologies in clinical trials. Specifically, this programme is focused on:

1. Novel clinical trial designs, including biomarker driven, platform and N = 1 trials
2. Novel analysis methodologies, including testing of novel endpoints and improved statistical techniques
3. Improved data collection, including expanded datasets for prediction of outcomes, monitoring of endpoints and analysis.
4. Improvements in trial management using technology and other approaches

We partner closely with the HRB- Trials Methodology Research Network in this space.

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