Our services

We have an interdisciplinary team with experience in trial methodology, statistics, data management, trial management, qualitative research, and health economics. We share expertise across ARU’s Faculty of Health, Medicine and Social Care, including qualitative researchers, methodologists, and health economists who collaborate on projects with us.

We are able to provide support over the lifetime of the study, from applying for funding through to closedown and reporting. We are also able to provide consultancy for planned trials, research design, and other research activities. All ARCTU studies are conducted in accordance with ICH GCP.

Comprehensive trial development and conduct

Our team has vast expertise in assisting researchers to establish robust clinical trials including:

• Identifying potential funders and funding opportunities
• Helping design the clinical trial (including methodological and statistical support from relevant ARCTU experts and collaborators)
• Supporting you through the application process
• Compiling trial costings.

We also work with colleagues from ARU's Let’s Shape Research Together programme, which enables members of the public to collaborate with academics at the early stages of research design.

Statistical support

We have expertise in medical statistics and can help advise on the design, conduct, analysis, and reporting of studies. Some of the aspects we can support you with are:

• Sample size calculations
• Statistical plan development
• Reporting to trial committees
• Data analysis, interpretation, and reporting.

Data management

We can provide support on all aspects of data management from design through to data collection and cleaning to archiving of the dataset. Our services include:

• Case report form (CRF) design, to ensure that data collection supports the analysis plan
• Developing and hosting validated electronic data capture systems that are GCP compliant and have in-built query management systems
• Providing web-based randomisation services
• Providing data management plans and data dictionaries
• Quality checking and cleaning data
• Managing study closedown and database lock
• Providing controlled access to study data.

Trial management

We can provide expertise in managing your study to successful delivery. We can assist you with:

• Drafting protocols in collaboration with clinicians and the project team
• Developing supporting documents (e.g. consent forms, participant information sheets)
• Preparing and managing submissions to regulatory and ethical bodies
• Identifying sites and organising initiation/training visits
• Managing and tracking budgets/spend on research grants
• Creating and managing trial master files
• Providing day-to-day trial oversight and management
• Quality control
• Pharmacovigilance and reporting of safety events
• Organising trial management and steering group meetings
• Managing trial amendments
• Implementing site closedown and archiving

Get in touch

If you're considering designing or implementing a clinical trial as part of your research study, we can talk you through the detail. Email us at [email protected]

If you're ready to request our services, fill in our collaboration request form.

We'll then invite you to to present your project at the CTU’s Monthly Trial Adoption Meetings. Please note that if the deadline for your project is tight, the CTU Directors may review and assess your application directly, to streamline the process.