Developing and delivering clinical and applied health and care research
Working with us
- the level of engagement sought
- the experience of your research team
- the size and complexity of the project
- the source of funding and our own capacity
Please contact us as early as possible so we can help you plan your research and include the costs of our support in your grant application. PenCTU does not provide funding for research.
If you need help with an existing study, please ensure you have sufficient funds to meet the costs of our support.
Peninsula Clinical Trials Unit
Faculty of Health
University of Plymouth
ITTC 1 Building
Plymouth Science Park
We help investigators to: refine research questions; develop the study design, including sample size; consider regulatory/ethical issues; calculate resources; identify suitable funding sources and develop high-quality funding applications.
Dedicated trial management
Effective trial management pulls all critical elements of a trial together to ensure its successful delivery on time and within budget and to a high standard.
Data Management and Systems development
We design and develop efficient data collection tools. In addition to systems for storing and processing trial data, our dedicated team of IT developers build administrative systems to facilitate overall project data management.
Quality assurance and regulatory compliance
Our Quality Management System ensures trials are conducted according to the principles of GCP (Good Clinical Practice) and regulatory requirements. Project-specific risk assessments inform proportionate monitoring and management plans.
Our web-based randomisation systems facilitate 24-hour, 7-day availability, support static or dynamic algorithms, ensure robust allocation concealment measures in blinded trials and can auto-generate reports of random allocation (paper-based available)
Analysis and reporting
Our statisticians work with Chief Investigators to develop statistical analysis plans, prepare code for analysis, provide expertise in handling missing data, conduct final analyses and inform results write up.
We can also help with ...
Obtaining and maintaining permissions
We can guide you through the IRAS system in order to obtain a favourable ethical opinion, HRA approval and other permissions as required (including authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the case of drug trials). We ensure that essential documents are prepared on time and in the correct format and that amendments are prepared and submitted to the relevant bodies in a timely and organised manner.
Writing a trial protocol can be a complex business but we can help you to write your protocol in line with recommended guidelines using tried and tested templates.
Patient & public involvement and engagement (PPI)
The benefits of PPI in research are well documented. We can help you decide how to ensure effective PPI input throughout the life-cycle of your project.
Investigator site set up
No matter whether your study is single or multi-centre, it is essential that all are adequately resourced to conduct the study and staff are fully acquainted with the protocol. We can help with site selection, design/delivery of staff training and coordination of site study supplies.
We design systems for recording Adverse Events (AEs) and Serious Adverse Events (SAEs) in all studies and have robust mechanisms for safety reporting within CTIMPs (Clinical Trials of Investigational Medicinal Products).
Investigational Medicinal Product (IMP) management
We supervise all aspects of IMP management including designing regulatory-compliant product labels, reliable supply chains, robust drug accountability systems and procedures for emergency unblinding.
Most studies require a Trial Steering Committee (TSC) to oversee the local management group. Some trials also need a Data Monitoring Committee (DMC). We can help with the proper constitution of these committees, identify appropriate members, arrange regular meetings and prepare the required reports.