Our services and expertise
We will collaborate with you to support the design, conduct, analysis and reporting of your clinical trial or other well-designed health, social and educational intervention or technology study. Our current portfolio includes trials in cancer, diabetes, heart disease, lifestyle and respiratory among others.
Our priority areas include NIHR funded trials, multi-site or single site RCTs, trials in which the LCTU is providing full trial management, and other high quality trials funded from medical charities and industry seeking to answer important research questions.
We have multidisciplinary teams including clinical, quality, statistical, database and trial management expertise.
At LCTU we can provide specialist input in the following areas:
- Trial development
- All aspects of trial design and methodology
- Support with funding application writing, budgeting and submission
- Protocol and funding application peer review
- Protocol design, development and outcome measure advice
- Protocol writing using standard templates
- Design and review of Case Report Forms or questionnaires
Bespoke database solutions and IT
LCTU has a strong focus on quality, standards and consistency. We ensure robust high quality database design through Trial Managers, Statisticians and Database Developers working together as an integrated team.
- Database design, validation and data management
- Web based data capture, data entry and quality control
- Data query management
- Independent data monitoring
- Provision of cleaned and locked datasets, DSMC etc.
- Archiving of databases
Trial conduct and management
- Responsible for obtaining REC, MHRA, HRA and other regulatory approvals as demanded by the research
- Engagement with sites, site set-up, study specific training and initiation
- Central trial management (from trial set up to close down)
- Financial management
- Randomisation: Web-based or by telephone
- Unblinding / code breaking
- GCP advice
- Trial Monitoring
- Review or writing of the clinical study report
- QA and audit preparation
- Definition and consolidation of outcome measures
- Provision of advice and support for statistical analysis
- Sample size calculation
- Writing or review of statistical analysis plans
- Statistical analysis and reporting