Programmes

The Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI) was established in 2020 to support the development and delivery of novel therapeutics and medical devices in the UK, through advanced regulatory standards and tools. 

A truly multidisciplinary initiative, CRSI will bring together experts in medicinal science, health policy and management, clinical trial design, medical law and patient-reported outcomes research, from across BHP member organisations. 

Its key research themes include:

  • Patient-centred drug development
  • AI in healthcare
  • Accelerated access to medicines
  • Real-world data collection
  • Innovative trial design
  • Medical technologies

Recent years have seen a rapid acceleration of discovery in fields such as personalised medicine, health data, AI, digital health and drug discovery. Alongside these developments, we are establishing novel methods of clinical trial design and growing the role of the patient in medical innovation – from Patient and Public Involvement and Engagement to Patient-Reported Outcomes Research

To ensure the safe and effective use of these innovations however, it is vital that we are able to validate, evaluate and legislate at an equally swift pace. Here, cross-sector partnership working is critical if the UK is to achieve its Life Sciences Industrial Strategy objectives, support the growth emerging markets and support the NHS with innovative therapies – all in the safest and most effective way for patients. 

Regulatory science achieves this by bringing together multiple disciplines with one focus – ensuring the quality, safety and efficacy of new medicinal products throughout their lifetime: from drug discovery and clinical trials, to introduction and adoption in clinic. 

The mission of the CRSI is to drive innovation in regulatory science to promote efficient, safe and cost-effective implementation of new therapies, for the benefit of patients and society

It works to identify critical emerging challenges in UK regulatory science; prioritise strategic areas in which to develop regulatory standards; implement effective cross-sector training platforms; and design the UK-wide infrastructure needed to drive this agenda across a broad range of stakeholders. 

The Centre’s activity is broadly grouped into three pillars: policy development; research and innovation; and capacity building and education. In line with these pillars, CRSI will:

      • Generate evidence to support advances in regulation
      • Convene national and international debate between key stakeholders
      • Provide training and support in regulatory science
      • Develop international consensus-based guidance for healthcare in cutting edge disciplines. 

The Centre also enables BHP to deliver effective, safe and affordable novel therapies to NHS patients through a well-resourced and coherent approach to R&D and regulation. Working through our established network, these therapies will benefit patients throughout the UK healthcare system.

The Centre leverages Birmingham Health Partners’ established profile and expertise in several key areas:

Patient-reported outcomes
Clinical trials
Artificial intelligence
Advanced therapies
Healthcare technology
      • Birmingham’s Healthcare Technologies Institute leads research in new technologies and treatments – including encouraging better tissue healing and rehabilitation tools
      • The Medical Devices Testing and Evaluation Centre (MD-TEC) supports medtech and life sciences businesses with design and development, validation, human factors engineering, usability studies and regulatory compliance 

Further reading:

Contact us:

Centre Director and Academic Lead – Professor Melanie Calvert: m.calvert@bham.ac.uk

Administrative Contact – Dr Eliot Marston: e.d.marston@bham.ac.uk

Advanced Therapies Facility

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The purpose-built Advanced Therapies Facility (ATF) building opened in 2011, funded largely through the Advantage … Continue reading "Advanced Therapies Facility"
BHP Centre for Regulatory Science and Innovation

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The Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI) was established in 2020 … Continue reading "BHP Centre for Regulatory Science and Innovation"
Birmingham Centre for Clinical Trials (BCCT)

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The Birmingham Centre for Clinical Trials (BCCT) brings together clinical trial expertise from across the … Continue reading "Birmingham Centre for Clinical Trials (BCCT)"
Birmingham Clinical Trials Unit (BCTU)

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The Birmingham Clinical Trials Unit (BCTU) is a leading national clinical trials unit specialising in … Continue reading "Birmingham Clinical Trials Unit (BCTU)"
Birmingham Drug Discovery Facility

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Based within BHP founder member the University of Birmingham, the Drug Discovery Facility enables our … Continue reading "Birmingham Drug Discovery Facility"
Cancer Research UK Clinical Trials Unit (CRCTU)

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From concept to completion: The Cancer Research UK Clinical Trials Unit (CRCTU) quickly and safely translates … Continue reading "Cancer Research UK Clinical Trials Unit (CRCTU)"
Centre for Clinical Haematology

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The Birmingham Centre for Clinical Haematology oversees one of the most active academic and clinical … Continue reading "Centre for Clinical Haematology"
Centre for Computational Biology

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The Centre for Computational Biology (CCB) brings together a multidisciplinary team of experts drawn from … Continue reading "Centre for Computational Biology"
Centre for Custom Medical Devices

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Bringing together multidisciplinary expertise, the Centre for Custom Medical Devices (CMD) was established to explore … Continue reading "Centre for Custom Medical Devices"
Centre for Human Brain Health (CHBH)

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The Centre for Human Brain Health (CHBH) is a collaboration between the College of Life … Continue reading "Centre for Human Brain Health (CHBH)"
Centre for Patient Reported Outcomes Research (CPROR)

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Based at BHP founder member the University of Birmingham, the Centre for Patient Reported Outcomes … Continue reading "Centre for Patient Reported Outcomes Research (CPROR)"
Centre for Rare Diseases

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Situated in the Heritage Building (former Queen Elizabeth Hospital) at the heart of the BHP … Continue reading "Centre for Rare Diseases"
Clinical Immunology Service

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The Clinical Immunology Service provides a full range of immunological investigation services, offering the highest quality … Continue reading "Clinical Immunology Service"
Experimental Cancer Medicine Centre (ECMC)

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The Experimental Cancer Medicine Centre (ECMC) Network was established in 2007 and now has 18 … Continue reading "Experimental Cancer Medicine Centre (ECMC)"
Genomics Birmingham

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Genomics Birmingham is a resource centre providing a range of genomic services, along with a … Continue reading "Genomics Birmingham"
Health Services Management Centre (HSMC)

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A critical friend of the healthcare community: The Health Services Management Centre (HSMC) at BHP … Continue reading "Health Services Management Centre (HSMC)"
Healthcare Technologies Institute (HTI)

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The Healthcare Technologies Institute (HTI) brings together leading experts from a variety of disciplines across … Continue reading "Healthcare Technologies Institute (HTI)"
Henry Wellcome Building for Nuclear Magnetic Resonance (NMR) Facility

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The Henry Wellcome Building for Nuclear Magnetic Resonance (NMR) is the UK’s largest biomolecular NMR … Continue reading "Henry Wellcome Building for Nuclear Magnetic Resonance (NMR) Facility"
Human Biomaterials Resource Centre

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The Human Biomaterials Resource Centre (HBRC) is a human sample biorepository, licensed by the Human … Continue reading "Human Biomaterials Resource Centre"
Inflammation Research Facility (IRF)

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The Inflammation Research Facility (IRF) is a clinical facility focusing on inflammation based within QEHB … Continue reading "Inflammation Research Facility (IRF)"
Institute for Mental Health

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The Institute for Mental Health (IMH) has been established to maximise the collaborative efforts of … Continue reading "Institute for Mental Health"
Institute of Translational Medicine

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The Institute of Translational Medicine (ITM) is a place where scientists, researchers, clinicians and industry … Continue reading "Institute of Translational Medicine"
Medical Device Testing & Evaluation Centre (MD-TEC)

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Based within BHP's Institute of Translational Medicine, MD-TEC is a custom-built facility designed to support … Continue reading "Medical Device Testing & Evaluation Centre (MD-TEC)"
Midlands & Wales Advanced Therapy Treatment Centre (MW-ATTC)

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The Midlands and Wales Advanced Therapy Treatment Centre (MW-ATTC) is part of the wider ATTC … Continue reading "Midlands & Wales Advanced Therapy Treatment Centre (MW-ATTC)"
NIHR Applied Research Collaboration (ARC) West Midlands

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The NIHR Applied Research Collaboration (ARC) West Midlands is a five-year (2019-2024) initiative funded by … Continue reading "NIHR Applied Research Collaboration (ARC) West Midlands"
NIHR Birmingham Biomedical Research Centre (BRC)

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The NIHR Birmingham BRC brings together the expertise of University Hospitals Birmingham NHS Foundation Trust (UHB) … Continue reading "NIHR Birmingham Biomedical Research Centre (BRC)"
NIHR Surgical Reconstruction & Microbiology Research Centre (SRMRC)

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The NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC) is a national hub for trauma … Continue reading "NIHR Surgical Reconstruction & Microbiology Research Centre (SRMRC)"
NIHR Trauma Management MedTech Co-operative (Trauma MIC)

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We are one of 11 NIHR MedTech and In Vitro diagnostics Co-Operatives (MICs) across England. … Continue reading "NIHR Trauma Management MedTech Co-operative (Trauma MIC)"
NIHR/Wellcome Trust Birmingham Clinical Research Facility (CRF)

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The Birmingham NIHR/Wellcome Trust Clinical Research Facility (CRF) is a truly integrated BHP centre. Its … Continue reading "NIHR/Wellcome Trust Birmingham Clinical Research Facility (CRF)"
Scar Free Foundation Centre for Conflict Wound Research

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Birmingham has long provided specialist care for injured members of the armed forces, with the … Continue reading "Scar Free Foundation Centre for Conflict Wound Research"
The BioHub Birmingham

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The BioHub Birmingham is a bioincubator at the heart of a support ecosystem for biomedical … Continue reading "The BioHub Birmingham"
The Centre of Membrane Proteins and Receptors (COMPARE)

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The Centre of Membrane Proteins and Receptors (COMPARE) is a unique collaboration between the Universities … Continue reading "The Centre of Membrane Proteins and Receptors (COMPARE)"