Clinical Trials and Data

Clinical Trial Approval

• For Clinical Trials of Investigational Medicinal Products (CTIMPs), sponsors submit applications through the Integrated Research Application System (IRAS). Applications are assessed through the UK Combined Review service, which brings together MHRA Clinical Trial Authorisation (CTA) review and Research Ethics Committee (REC) review within a single application process.

• Following Combined Review, studies involving NHS organisations require national research governance approval. In England and Wales this is provided through Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval. These processes assess governance and legal compliance and support study set-up at participating NHS organisations.

• The CTA issued by the MHRA and the favourable opinion issued by a REC apply across the UK. There are arrangements across the UK for NHS research governance, with HRA and HCRW Approval required for participating NHS organisations in England and Wales

• Updated UK Clinical Trials Regulations and associated Good Clinical Practice (GCP) requirements came into force on 28 April 2026 and apply across all four UK nations.

• Key changes introduced by the updated regulations include:

  • A legally established and streamlined approval process for CTIMPs, with coordinated MHRA and REC review through a single application route.  

  • Enhanced transparency requirements, including registration of clinical trials and publication of trial results, together with information suitable for participants and the public.  

  • Updated pharmacovigilance and safety-reporting requirements intended to simplify processes while maintaining participant protections.  

  • A greater emphasis on proportionate, risk-based trial management and compliance with internationally recognised Good Clinical Practice principles.  

Commercial Research in Wales

• Wales is actively contributing to enhancing the UK's attractiveness as a destination for global pharmaceutical companies and is committed to delivering rapid and reliable study set-up and recruitment for commercial research.

• Wales offers a number of distinctive advantages for commercial research while remaining aligned with UK-wide processes for research governance, approvals and contracting.

• Through the One Wales approach, sponsors can access a coordinated national system supported by a highly skilled and well-connected research delivery workforce. Health and Care Research Wales provides a central point of contact for sponsors to identify sites in Wales, informed by clinical input from national specialty leads and up-to-date information on capability and capacity. This includes identifying where One Wales models can be used in trial delivery, either through established regional and national clinical pathways or through bespoke arrangements for individual studies. Health and Care Research Wales also supports sponsors through study set-up, with central performance monitoring and targeted intervention to address barriers where needed.

• Once sites have been identified, Wales's high levels of clinical need, specialist clinical networks and compact geography can support reliable recruitment and strong participant retention across a broad range of commercial research, from rare diseases to common medical conditions.

• Wales is also strengthening its advanced data capabilities to further enhance research delivery. Assets such as the Secure Anonymised Information Linkage (SAIL) Databank create opportunities to improve participant identification, feasibility assessment, and recruitment through the use of routinely collected healthcare data and work is underway to ensure this can be targeted at commercial research.

• Investment through the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), combined with existing research infrastructure, has expanded national capacity and capability for commercial research, enabling it to build on its established strengths.

• The Wales Commercial Research Delivery Centre (CRDC) was established in 2025 alongside equivalent centres across the UK and initially focused on four research teams with an established track record in commercial study delivery and the capacity to expand their activity:

  • Children and Young Adults Research Unit (Cardiff)

  • Cystic Fibrosis and Respiratory Research (Cardiff)

  • Nephrology and Transplant Research (Cardiff)

  • Velindre Cancer Centre

• Further investment through the programme has supported additional teams with strong potential for growth and strengthened national infrastructure that can streamline trial delivery, including:

  • Primary Care and Community Research Delivery Network (PCCRDN)

  • Regional and national imaging infrastructure

  • All-Wales Medical Genomics Service (AWMGS)

  • Advanced Therapies Wales (ATW)

• Together, Wales' established research infrastructure, targeted investments, and coordinated delivery model are creating a growing network of sites across all specialties capable of delivering commercial research efficiently and consistently within a single national system.

• To learn more about how Health and Care Research Wales can support you, or to discuss potential sites in Wales for a specific study, please contact the industry team: industry-research@wales.nhs.uk

Commercial Model Clinical Trial Agreements 

• The model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) templates should be used for industry-sponsored clinical trials of investigational medicinal products with NHS / HSC participants in hospitals throughout the UK.
  
  
• The mCTA was updated in May 2025.

Health and Care Research Wales

• As well as approving clinical trials with the HRA, Health and Care Research Wales (HCRW) have a number of other roles.
  
  
• HCRW supports and promotes high-quality health and care research across the NHS in Wales, working with universities, local authorities, research institutions, and the third sector. It encourages health and social care professionals to engage in research and provides resources and training to facilitate their involvement.
   
• HCRW also invests in specialty leads to build networks of principal investigators, champion research development, and support study delivery across Wales.
  
  
• HCRW are delivering the ‘Data for Research’ programme, which builds on recommendations in Lord O’Shaughnessy’s report regarding the use of data to support trial recruitment.

• The UK Health Data Research Service (HDRS) is a collaboration across all four nations of the UK. Wales has some of the UK’s most mature health data infrastructure and services and is well-placed to inform the development of the HDRS.

SAIL Databank

• The SAIL Databank provides robust secure storage and use of anonymised person-based data for research to improve health, well-being and services. Its databank of anonymised data about the population of Wales is internationally recognised, and a key resource for HCRW.
   
• It is a Trusted Research Environment (TRE) for billions of person-based records, which enables researchers to answer important questions for the benefit of society. Researchers can access a broad range of routinely collected data spanning up to 30 years from an entire population.
  
  
• HCRW access SAIL data to provide insight on potential trial participant populations alongside site capabilities in discussions with sponsors as part of the ‘One Wales’ model.
  
  
• SAIL are committed to working with researchers, the NHS and other health-related to conduct projects that lead to enhanced patient care, public benefit and improvements in health and wellbeing, and support better policy making, practice and citizen wellbeing. Previously, SAIL’s data access policy has restricted use of SAIL data by commercial researchers, including pharmaceutical companies. However, advocacy by the ABPI has led to SAIL changing their policies, which now allow industry access to data for research in line with that offered to non-commercial researchers.

Digital Health and Care Wales

• Digital Health and Care Wales are a Special Health Authority that create digital solutions to improve health and care in Wales.

• DHCW also collect and publish data from sources including hospitals, clinics and other health services across Wales.