Anglia Ruskin Clinical Trials Unit services

Our methodologists work with you to identify the most appropriate study design – whether an RCT, feasibility study, diagnostic accuracy evaluation, stepped-wedge cluster trial, or real-world evidence study.

• Research question refinement and PICO development
• Protocol development and peer review
• Sample size calculation and power justification
• Adaptive and Bayesian design support

At ARCTU, we have particular expertise in feasibility and pilot study design, including formal progression criteria and embedded process evaluations, following CONSORT and NIHR guidance.

• Feasibility study design and protocol
• Progression criteria development
• Recruitment rate and retention assessment
• Intervention acceptability evaluation

Our in-house health economists provide cost-effectiveness analyses, economic models and value of information analyses – see also the Health Economics Advisory service on Innovation and medical devices.

• Decision analytic modelling
• Cost-utility and cost-effectiveness analysis
• Budget impact analysis
• NICE submission support

We use established electronic data capture platforms to build, validate and manage case report forms in accordance with ICH E6(R2) GCP.

• eCRF design, build and validation
• Data management plan development
• GDPR-compliant data governance
• Database lock and data archiving

Validated web-based randomisation services including simple, stratified, minimisation and adaptive allocation – fully auditable.

• Simple, stratified and minimisation randomisation
• Web-based access for site staff
• Emergency unblinding procedures

From site set-up to close-out, our trial managers keep studies on track in multi-site NHS settings.

• Site selection, feasibility and set-up
• Recruitment monitoring and escalation
• Trial master file (TMF) management
• Study close-out and archiving

Expert support for MHRA CTA applications, HRA/NHS REC ethics submissions and NHS R&D approvals – see also the Regulatory Advisory service on Innovation and medical devices for device and SaMD-specific support.

• MHRA CTA preparation and submission support
• HRA / NHS REC ethics application support
• ISO 14155 and device-specific regulatory pathways

Rigorous qualitative work – interviews, focus groups, thematic analysis, acceptability studies – delivered standalone or embedded in trials.

PPIE is built into the way we work. We have an established relationship with ARU's Let's Shape Research Together programme.

• PPIE strategy development
• Patient Advisory Group setup and facilitation
• Co-design workshops with patient and public partners

We help develop compelling research proposals with realistic, defensible costings. Experience includes NIHR RfPB, HTA, Innovate UK, SBRI Healthcare and charity funders.