Leicester Clinical Trials Unit

Our services and expertise

LCTU 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. LCTU's current portfolio includes trials in clinical disciplines such as cancer, cardiovascular, diabetes, lifestyle and respiratory among others.

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.

LCTU has a wealth of expertise in multidisciplinary teams which include: Clinical, Quality, Statistics, Database and Trial management.

LCTU can provide specialist input in the following areas:

  1. Trial development
  2. All aspects of trial design and methodology
  3. Support with funding application writing, budgeting and submission
  4. Protocol and funding application peer review
  5. Protocol design, development and outcome measure advice
  6. Protocol writing, using standard templates
  7. Design and review of Case Report Forms (CRFs) or Questionnaires/Surveys

Quality management, bespoke database solutions and IT

LCTU has a strong focus on Quality and Governance. Standards and consistency ensure robust high quality database design while Trial Managers, Statisticians and Database Developers work together as an integrated team to deliver Trial Databases.

Using Elsevier MACRO Electronic Data Capture (EDC) LCTU provide the following:

  1. Database design, validation and data management
  2. Web based data capture, data entry and quality control
  3. Data query management
  4. Independent data monitoring
  5. Provision of cleaned and locked datasets, DSMC etc.
  6. Archiving of databases
  7. QA and audit preparation

Trial conduct and management

  1. Responsible for obtaining REC, MHRA, HRA and other regulatory approvals as determined by the research
  2. Responsible for obtaining REC, MHRA, HRA and other regulatory approvals as demanded by the research
  3. Engagement with sites, site set-up, study specific training and initiation
  4. Central trial management (from trial set up to close down)
  5. Financial management
  6. Randomisation: Web-based or by telephone
  7. Unblinding / code breaking
  8. GCP advice
  9. Trial Monitoring
  10. Review or writing of the clinical study report

Statistical analysis

  1. Definition and consolidation of outcome measures
  2. Provision of advice and support for statistical analysis
  3. Sample size calculation
  4. Writing or review of statistical analysis plans
  5. Statistical analysis and reporting

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