Overview

NWORTH, The Bangor Trials Unit forms part of the Institute of Medical and Social Care Research (IMSCaR) within the College of Health & Behavioural Sciences (CoHABS) at Bangor University. NWORTH is a NISCHR funded Clinical Trials Unit under the umbrella of NISCHR Clinical Research Centre (NISCHR-CRC).

The unit was awarded full Clinical Trials Unit UKCRC registered status in November 2007 . This was in recognition of achieving the very high standards and demonstratable evidence in fulfiling the criteria and core competencies (as defined by the UKCRC) by providing a full spectrum of expertise required to deliver high quality clinical research and the capability to centrally co-ordinate multi-centre trials to the highest standards.

All of our studies are governed by our suite of Standard Operating Procedures (SOP's) specifically developed for managing all aspects of our clinical studies to the highest of standards. These have been written in compliance with current regulatory requirements and principles of Good Clinical Practice (GCP), Research Governance Framework, EU Clinical Trial Directive and other guidelines (NHS guidelines/policies/clinical governance).

Aims and Objectives

The unit's core aim is to improve the health and well being of the people of Wales and beyond by evaluating complex interventions in health and social care.

Our primary objectives are to:

How can we assist ?

NWORTH offers a flexible and integrated approach, comprising of a multi-disciplinary and multi-functional team. These include Clinicial Academics, Statisticians, Data Managers, Health Economists, Trial Managers, QA and IT Specialists. With expertise and experience accross broad areas of clinical research from initial idea generation to final publication and dissemination, we can support you by providing access to core competencies of trial design, trial co-ordination, data managment and statistics.

The Unit also provides and implements effective IT solutions in support of our studies with the application of electronic data capture systems and innovative remote web-based randomisation systems.

All our work is underpinned by a robust Quality Management System and Standard Operating Procedures that meet all current legislative requirements in line with GCP and we adopt best practice throughout.

What do we do?

NWORTH can provide practical support and bespoke advice in both partnership and collaboration with all aspects your study from design, conduct, analysis through to reporting and dissemination. At each stage of clinical trial development and conduct, the unit provides expertise in all areas thus ensuring the trials are run to the highest quality. If you have a study in mind then please contact us to discuss your requirements.

Trial design and governance

• Grant applications and protocol writing
• Progressive trial design
• Trial development and management
• Trial governance and process evaluation

Trial methodology

• Outcome measurement
• Economic evaluation
• Methodological research
• Sample size and power calculations
• Statistical analysis plans
• Service user involvement

Data management and analysis

• Electronic data capture and e-CRF design
• Specialist software MACRO and IT support
• Remote web-based randomisation
• Database design and Data validation
• Statistical analysis

Randomisation Service

• Web-based individual, group or cluster randomisations
• Secure, dynamic, stratified system
• Easy to commission
• Provide ongoing support and training

QA & Compliance

• SOP development
• Auditing
• Research governance issues
• IRAS application