TCTU provides expertise throughout the lifecycle of a clinical trial, from clinical trial planning, regulation submissions, set-up, trial management, data management, analysis and publication.

We can also help with individual aspects of the clinical trial lifecycle where full trial delivery is not required, by providing bespoke packages to your project needs.

TCTU will guide you through the pre-award process for a clinical trial and provide trial design guidance, including:

  • Pre-award support (see TASC pre-award process)
  • Trial design
  • Trial methodology
  • Patient pathways
  • Power calculations
  • Grant application development
  • Identifying resources and budget preparation
  • Coordinating third party providers

TCTU have a team of experienced clinical trial managers and support staff who can successfully manage your trial. We offer a range of trial management support, including:

  • Protocol development
  • Regulatory submissions to local governance, ethics, MHRA
  • Recruitment strategies
  • Trial set-up
  • Site training
  • Ongoing trial management
  • Trial close out
  • Reporting and publications

The TCTU data management team will work with you to optimise data capture for your trial. We offer a range of data management services, including:

  • Case Report Form (CRF) design
  • Data management plan (DMP) pre-award and post-award
  • System build & validation
  • System maintenance
  • User training and management
  • Management of multiple data sets
  • Data capture
  • Data auditing
  • MedDRA coding
  • Serious adverse events (SAE) reconciliation
  • Data extraction
  • Data validation
  • Database lock

TCTU has dedicated statisticians to provide support for your study, including:

  • Pre-award design
  • Sample size calculations
  • Statistical analysis plan (SAP)
  • Input into CRF
  • Input into data management system design
  • Statistical reporting
  • Supporting data monitoring committee
  • Interim analysis
  • Final analysis

The Tayside Randomisation System (TRuST) is a GCP compliant randomisation and drug management interactive web response system (IWRS) suitable for CTIMP, non-CTIMP and complex intervention trials. TRuST offers a range of functions, including:

  • Randomisation
  • Stratification
  • Minimisation
  • Clustering
  • Multiple randomisation
  • Drug accountability
  • Release/request forms
  • Titration/dose changes
  • Restock triggers
  • Emergency unblinding
  • Monitoring

TCTU can also coordinate external support for your trial, including:

  • Health Informatics Centre (HIC)
    examples: Safe Haven, data linkage, data entry, data collection
  • NHS Research and Development
    examples: approval for sites, project costings
  • TASC monitoring
  • TASC pharmacovigilance
  • Pharmaceutical provider
  • Tayside Biorepository (TBR)
    examples: tissue collection, registering samples, processing samples
  • Clinical Research Centre (CRC)
    examples: research nurse, imaging, use of facilities