Signposting Directory

The UK hosts a network of research infrastructure supporting the design, delivery, and regulation of advanced therapy clinical trials. Whether developing gene therapies, cell therapies, or tissue-engineered products, this directory of resources highlights key networks and services that will help you deliver cutting-edge trials efficiently and safely across the UK.

The resources in this directory have been categorised into six sections. Jump to each section by clicking the relevant title below.

Please note: The content of this page was developed by the ATTC network and published on 13/04/2026. The information provided on this website is for general informational purposes only. Although we make all reasonable efforts to ensure the information is up to date, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, or suitability of the information.

Regulatory and Approval Organisations

Regulatory Authorities

Regulatory approvals are required before conducting clinical trials in the UK. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the competent authority for the UK and is responsible for clinical trial approvals, oversight, and inspections. It also regulates medicines, medical devices and blood components for transfusion in the UK. Sponsors/CROs can get scientific advice from the MHRA at any stage of ATMP development.

For clinical trials with Genetically Modified Organisms (GMOs) either the Health and Safety Executive (HSE) or the Department of the Environment, Food and Rural Affairs (DEFRA) are the competent authority. The use of gene therapy containing a GMO falls under Contained Use (HSE) or Deliberate Release (DEFRA).

Integrated Research Application System

The Integrated Research Application System (IRAS) provides a single system for necessary permissions and approvals for health and social care research in the UK. The system submits to both the MHRA and a REC at the same time.

Setting up Sites across the UK

Guidance on how to apply to conduct research in NHS/Health and Social Care (HSC) organisations and who to contact for further advice is based on where the lead NHS/HSC R&D office is located. For studies with sites in more than one UK nation, there are compatible arrangements across the UK to ensure that reviews applicable to the study are shared across all sites. Information should be provided to each NHS/HSC participating organisation in accordance with the guidance provided by the relevant nation:

England & Wales
HRA/Health and Care Research Wales (HCRW) approval is a combined process for applying for approvals for all project-based NHS and social care research taking place in England or Wales.

You will need to ensure you are conducting research to required standards and are compliant with relevant legislation. Further information can be found on our conducting your research to the required standard page. Information on planning your study is also available in the research planning section on the HRA website.

Scotland

Northern Ireland

Gene Therapy Advisory Committee

The Gene Therapy Advisory Committee (GTAC) is the UK’s Research Ethics Committee (REC) for gene therapy clinical research. GTAC ensures applications for ethical approvals for gene therapy clinical trials are processed through appropriate channels.

Human Tissue Authority

The Human Tissue Authority (HTA) sits under the Department of Health and Social care and independently regulates organisations that remove, store and use human tissue for research, human application for medical treatment, post-mortem examination, education and training, and display in public. They monitor, inspect, and regulate organisations ensuring that these organisations are following correct procedures.

Government Research Organisations in the UK

England: National Institute for Health and Care Research

The National Institute for Health and Care Research (NIHR) provides funding to enable world leading health and social care research, improving the health and wellbeing of the UK population. It facilitates and enables research via the Research Delivery Network (RDN), Study Support Services, and dedicated research infrastructure.

The NIHR collaborates with government organisations across the devolved nations to deliver a streamlined service for health and social care research. Through their individual organisations, the devolved nations can also support research development and collaboration to deliver ATMP clinical trials.

Scotland: NHS Research Scotland (NRS)

NHS Research Scotland (NRS) promotes and supports excellence in clinical and translational research in Scotland so that patients can benefit from new and better treatments. Formed through a partnership of Scottish NHS Boards and the Chief Scientist Office (CSO) of Scottish Government, NRS works to ensure that NHS Scotland provides the best environment to support clinical research.

Each study within Scotland lies within the remit of at least one Network or Specialty Group (SG), which are the key national bodies for supporting clinical research activity, acting as the interface between research sponsors, the NHS and patients themselves. They facilitate the development, set up and completion of clinical research studies across Scotland, improving the quantity and quality of research within their specific clinical area.

The NRS Centralised Feasibility Service works collaboratively across Scottish Health Boards to support feasibility reviews and site identification. The national approach results in fast, efficient, and reliable support to deliver high-quality clinical trials in Scotland.

Wales: Health and Care Research Wales (HCRW)

Health and Care Research Wales (HCRW) is a networked organisation, supported by Welsh Government, which brings together a wide range of partners across the NHS in Wales, local authorities, universities, research institutions, third sector and others.

They work in close partnership with other government agencies and research funders (both in Wales and across the UK); industry partners; patients; service users; the public and other stakeholders.

They work together to promote research into diseases, treatments, services and outcomes that can lead to discoveries and innovations which can improve and even save people’s lives.

HCRW funds a world-class research community to support and increase capacity in research and development.

The ‘One Wales’ Support and Delivery Service is a Wales-wide service which aims to provide seamless support to sponsors, researchers and the public. The service is delivered at a national level via the Support & Delivery Centre and national Specialty Leads, and at a local level via NHS research and development (R&D) departments.

The Support and Delivery services are delivered in a UK-wide context, working closely with counterparts across the other nations, to streamline research support and delivery services for the benefit of researchers.

Northern Ireland: Health and Social Care Northern Ireland (HSCNI)

Health and Social Care Northern Ireland (HSCNI) is the publicly funded health system integrating both health and social care services. It operates under the Department of Health, similar to the National Health Service (NHS) in other UK regions. The Health and Social Care Research and Development (HSC R&D) Division is part of the Public Health Agency. Its work is based on the principle that the best health and social care must be underpinned by knowledge, based on well conducted research, which can then be applied in the delivery of care.

Trial Delivery Infrastructure

Throughout the UK there is established research delivery infrastructure which supports delivery of clinical research.

UK Clinical Research Facility Network (UKCRF Network)

Clinical Research Facilities (CRFs) are state-of-the-art, purpose-built facilities based in NHS hospitals that are dedicated to delivering early phase, experimental medicine and high-risk studies. This includes first-in-patient trials and those that require dedicated space and specialist expertise. All CRFs in England and the devolved administrations are supported by the UKCRF Network.

Advanced Therapy Treatment Centre (ATTC) network

The ATTC network is a UK wide group of Advanced Therapy Treatment (ATTC) Centres operating within the NHS framework. The network addresses the unique and complex challenges of bringing pioneering ATMPs to patients.

Experimental Cancer Medicine Centres (ECMC)

ECMCs are a UK-wide network of specialist centres dedicated to advancing the development of new oncology treatments for adults and children.

Commercial Research Delivery Centres

The Commercial Research Delivery Centre (CRDC) works alongside life science organisations and research delivery infrastructures across the UK*, delivering commercial research. Their aim is to expand the recruitment of clinical trials beyond hospital Trusts into community and other trial settings.

*Commercial research delivery in Scotland will be delivered through the existing R&D Directorates.

Biomedical Research Centre

NIHR Biomedical Research Centres (BRCs) bring together academics and clinicians to translate early scientific breakthroughs into potential new treatments, diagnostics and health technologies.

UK Clinical Research Collaboration (UKCRC) Trial Units

Clinical Trial Units (CTUs) are specialist units that are experts in the design, execution, analysis, and publication of clinical trials and other studies that assess the efficacy and effectiveness of clinical therapies and treatments. Most CTUs can provide expertise in the set-up and delivery of clinical trials involving investigational medicinal products, which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials. Further information related to registered CTUs across the UK can be found on the UK CTU Network webpages.

Commercial and Industry Partners

Advanced Therapy Medicinal Product (ATMP) Roadmap

The Association of the British Pharmaceutical Industry (ABPI) has supported the production of the Advanced Therapy Medicinal Product (ATMP) Roadmap, which is a useful resource that sets out the key steps and activities in the end-to-end pathway for ATMP development. The roadmap contains a section dedicated to the planning, governance and conduct of clinical trials. Whilst primarily aimed at ATMP development in England, the roadmap also signposts where differences exist between devolved nations (Scotland, Wales and Northern Ireland) and by ATMP classification (i.e. cell, gene and tissue-engineered products).

Cell and Gene Therapy (CGT) Catapult

CGT Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies, with a vision for a thriving industry delivering life-changing advanced therapies to the world. Working with specialists across the system, CGT Catapult can provide expert support and advice for Sponsors/CROs, academia, and healthcare providers along the ATMP pathway.

Patient and Public Involvement and Engagement (PPIE)

ATMP Engage

ATMP Engage is the Advanced Therapy Medicinal Products Patient and Public Involvement and Engagement Working Group, which brings together various UK stakeholders to collaborate on PPIE activities. Their members include patient partners with lived or relevant experience, and representatives from charities, research, industry and health system organisations.

NIHR Patient and Public Involvement and Engagement

NIHR Patient and Public Involvement and Engagement (PPIE), ensures the inclusion of patients and the public in clinical development services to improve trial design and outcomes. The NIHR Patient Engagement in Clinical Development Service is specifically for life sciences organisations, and the link below will provide further information on how to access this.

NHS Research Scotland

Involving patients, service users and the public in the design and delivery of research is critical. This includes carers, patients, family and friends of patients, potential future patients and people who use health and social care services. If you are interested in joining the patient and public involvement community in Scotland, several groups run across Scotland focused on a range of therapy areas. To learn more, follow the link to the National Research Scotland website.

PPIE in Wales

Health and Care Research Wales assists in involving the public in research. They provide valuable support and resources to facilitate the inclusion of the public research development. Prior to applying for research award funding, researchers can access the Enabling Involvement Fund, which aids in public involvement during the development stage of a research project.

PPIE in Northern Ireland

In Northern Ireland, Health and Social Care Organisations have a legal duty to involve service users, carers, and the public in planning and delivering services, known as Personal and Public Involvement (PPI). PPI ensures that patients, carers, and the public are actively involved in clinical research as partners, not just participants.

Additional Advanced Therapy Resources

NHS Blood & Transplant

NHSBT Cellular and Molecular Therapies provides GMP manufacturing and translational support for academic and commercial advanced therapy programmes. Benefiting from integrated NHS infrastructure, we deliver plasmid, viral vector, and cell therapy manufacturing accelerating the transition from research innovation to clinical application through a collaborative, flexible, cost‑recovery model to maximise patient access to life-changing therapies.

Scottish National Blood Transfusion Service

The Scottish National Blood Transfusion Service (SNBTS) provides a specialist service for safe, high-quality blood, tissue and cell products and services in Scotland. Working collaboratively with health professionals, the SNBTS supports cell organ and tissue donation programmes across the UK.

SNBTS provides the cell collection service for the patients and donors of NHS Scotland. In addition, more about SNBTS involvement in advanced therapies can be found in the link below.

Advanced Therapies Wales

Advanced Therapies Wales (ATW) is a Welsh national programme dedicated to accelerating the development, adoption, and delivery of Advanced Therapies across Wales. It brings together healthcare providers, academia, industry, and government to create an integrated ecosystem that supports innovation in cell and gene therapies, regenerative medicine, and related technologies. By fostering collaboration, building specialist infrastructure, and developing workforce capability, ATW aims to work together within the Advanced Therapies global ecosystem, to deliver the benefits of these therapies to improve the health, wellbeing and prosperity of the people of Wales. Neuro is a key speciality in Wales, the Advanced NeuroTherapies Centre (ANTC) in Cardiff is the only UK site and one of only 5 worldwide delivering gene therapies to the human brain in First in Human and early phase clinical trials in neurodegenerative diseases. We were one of the two European sites delivering the uniQure AMT-130 gene therapy in Huntington’s Disease and currently are delivering the AskBio REGENERATE PD trials in Parkinson’s Disease and the AviadoBio ASPIRE-FTD trial.

Welsh Blood Service

The Welsh Blood Service plays a vital role in giving thousands of people across Wales a lifeline in their time of greatest need. They are also at the forefront of cutting-edge research and innovation. Their commitment to high-quality research extends across Wales and beyond, supporting their own researchers and collaborators in discovering new and improved treatments and enhancing healthcare services.

Specialist Pharmacy Service

The Specialist Pharmacy Service (SPS) composed of pharmacy professionals and support staff, is commissioned by NHS England to provide advice and guidance on medicines and their use, across the healthcare system. The Specialist Pharmacy Service via the Pan UK Pharmacy Working Group for ATMPs,  provides comprehensive information and resources for marketed and investigational ATMPS. Resources are  aimed primarily at Chief Pharmacists and their teams but also add insight and value for  Sponsors and Clinical Research Organisations (CROs) to support the provision of pharmacy clinical trial services.

To access advice and guidance related to clinical trials, and advanced therapy medicinal products, follow the links below:

NHS Readiness Toolkit

The NHS readiness toolkit provides resources for healthcare organisations that are working towards the delivery of advanced therapies for patients. It is intended for professionals across key specialisms involved in the delivery of advanced therapies. The resources within the toolkit are being developed by the ATTC network with a particular focus on providing support to research sites in the running of clinical trials of advanced therapies.

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