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• v.27(1-2); 2022 Mar

Perspectives: Reflections on the COVID-19 response: putting clinical research nursing on the map

Prior to COVID-19, Glasgow Clinical Research Facility (GCRF) was a busy clinical research unit with in excess of 100 multi-disciplinary team members undertaking approximately 400 studies in various stages of development – from set-up, open/recruiting, follow-up, closing down studies and archiving.

When we heard that the difficult decision had been made by the research leadership level to put the majority of these studies on hold in order to maintain participant safety and support the start-up process for the fast approaching COVID-19 clinical research portfolio, we were worried. The initial questions we asked all centred around the safety of our current participants; how would they get their bloods reviewed? Would they still receive their trial drugs? What if they reported an adverse event (AE), serious adverse event (SAE) or suspected unexpected serious adverse reactions (SUSARS)? A contingency plan was put in place to allow for scheduled follow-ups for patients involved in clinical trials of investigational medicinal products (CTIMPs) and other studies involving devices. Where possible these were conducted remotely using a direct-to-patient service for delivery of equipment, devices and medicines following medical or nursing review.

In a timeline that felt like overnight, we were reduced from running over 400 studies, to just a handful. It was no longer safe to bring participants into a hospital setting for routine research visits. As nurses, we were readying ourselves to join our colleagues in clinical areas to help with the massive influx of patients with COVID-19. Within days, however, new COVID-19 research protocols had been given approval to recruit and we were with our colleagues on the front line, but with a different remit: to collect as much information about the emerging disease as possible. As an often overlooked specialty in nursing, this was a proud moment for our clinical research nurses as it felt like we were able to do our part to help fight COVID-19, using our honed set of research skills to deliver essential information.

Urgent Public Health Research (UPH) focused on the coronavirus itself and its mode of action to help us understand the disease process and host response, development of safe and effective treatments and potential prophylaxis in the urgent quest for a vaccine. Our COVID-19 portfolio included studies of varying intensity from data collection, sample collection to intervention studies looking at possible drug treatments. Expedited approvals and a cohesive team approach enabled these studies to be actively recruiting within a short period of time, and all had high recruitment opportunity because of the sharp rise in hospital admissions with COVID-19. Expedited approvals and ever-changing amendments were, at times, difficult to keep up with which led to anxiety amongst the staff as this was a big change to our normal procedures. Excellent team working and regular meetings ensured we were able to implement these and maintain the safety of our participants.

Although we were used to working in a fast paced, pragmatic unit, we had to adopt a new working environment which led to a change, not only in the way we utilised the GCRF but also to our overall working conditions. The small group of patients who had to attend their regular safety visits were given a dedicated space and where possible, equipment within the GCRF, in order to minimise the risk of infection. Allocated clinic rooms were introduced for COVID-19 study visits and also for specific follow-ups where patients who had either been symptomatic and/or previously tested positive for COVID-19 could attend. Due to the acute clinical emergency presented by COVID-19 infection, we established a seven-day service and introduced extended working hours, which was not without challenges. Skill mix was at the forefront of the development of the new rotas in order to ensure that a steady mix of CRNs were available for ward reviews, including ICU/HDU, and non-COVID-19 reviews, whilst ensuring availability for early starts, later finishes and weekend working – all the while ensuring that the GCRF environment adhered to the government mandated social distancing guidance.

We split ourselves into three main teams (data entry, non-COVID-19 facing and COVID-19 facing), each team had their own tasks and challenges but each team had additional stresses – the COVID-19 facing team had the worry of knowing that despite the use of PPE, they were putting their health, and possibly families’ health, at risk to ensure good data was obtained; the non-COVID-19 and data team were worried for their co-workers and some of us felt guilty that our own health was impacting on us being able to share the COVID-19 facing team's workload.

A large majority of patients admitted to hospital with COVID-19 were given the opportunity to participate in research, but there was also a sense of guilt as we entered wards, HDU and ICU, and saw staff under immense pressure supporting patients with COVID-19. How could we offer a potential new treatment, collect our samples and then (it felt like) walk away? But of course if research was not able to continue through the pandemic, we would not have been able to offer patients and the public the hope of finding a treatment. So when the first evidence-based treatment of dexamethasone that came out of the RECOVERY study we had all been working on was announced, it felt like an incredible honour to have been part of this. We were under no illusion that we could not have achieved this without patients and their relatives agreeing to risk taking trial treatments, but as the nation clapped on a Thursday to support the NHS, a huge sense of pride was felt, and a few tears shed, knowing we had contributed to the national effort with our specialised research skills.

The logistics of further splitting the GCRF’s new teams became a challenge when the UPH COVID-19 vaccine portfolio was given ethical approval for initiation at site. The three main teams had to be split into further teams of blinded and un-blinded nurses. At this stage, the non-COVID-19 facing team felt like we had more to offer our colleagues as we could be more hands-on with overall aspects of the vaccine studies.

CRNs are used to having time for site initiation visits (SIVs) and investigator meetings where training is extensive and thorough. Due to the UK wide lockdown, these SIVs moved from face-to-face teaching to being carried out remotely via video link and in some cases, were completed in condensed intense sessions, which left some of the nurses feeling like we did not have enough preparation time to confidently start these trials. Our education team had been enveloped into the wider research team, but was still able to help immensely to close any information gaps by ensuring that small information sessions were held regularly and that we were all trained to deliver vaccines. Bi-daily team updates, known as huddles, were carried out to keep us updated on the ever-changing COVID-19 picture.

Vaccine clinics brought research into the news once again and the overwhelming support from volunteers willing to roll up their sleeve and risk a new vaccine was outstanding. Another intense effort from the whole research team enabled us to appoint, consent and vaccinate in a superhuman time frame to ensure that the data could be accurately analysed to advise the national vaccine programme. The stomach lurching moments were still part of the role; a waiting room full of volunteers waiting for safety data to be reviewed to allow for vaccination to continue; safe unblinding to be completed for hundreds of participants to allow them to get the now-approved Pfizer vaccine. Long hours were put in to ensure the safety of the participants and to ensure reliable data.

The constantly evolving COVID-19 portfolio resulted in a steep learning curve with a high turnover of documents and processes, again requiring a lot of flexibility from all teams as patients would require last minute changes to clinic appointments and documentation, new equipment being organised and set up. Adaptability is not only important for growth and development within the research nursing post but is also essential to allow you to rapidly learn new processes, techniques, behaviours and skills, especially in response to the continual changing requests and conditions that accompany research during a global pandemic.

Juggling COVID-19 work and restarting the postponed or halted research studies were now our priority. Believe it or not, life goes on and we needed to approach the ‘new normal’ with the enthusiasm and drive of pre-pandemic research. An influx of new staff is helping to support this but all need to be trained in research skills before they can work independently.

Supporting staff to work in such a dynamic and at times emotionally difficult environment was of paramount importance to our team. Managing the logistics and skill mix of the team to implement and safely carry out new complex trials during such a fast moving time tests all aspects of leadership, especially when the situation is compounded by a reduced nursing capacity due to an increased level of staff sickness prior to the testing programme being implemented for staff symptomatic of COVID-19.

Every member of staff within the GCRF has contributed to the COVID-19 pandemic showing admirable efforts in not only adapting their working schedule but also adjusting their role to accommodate the ever-changing practices. Like the rest of the NHS, there are staff members who went above and beyond, such as cancelling planned leave, postponing retirement, as well as increasing working hours in order to provide effective, essential research practice. Without research teams working tirelessly to provide data on COVID-19 disease progression, treatments and prevention, we would not be where we are today. It could be said that every cloud has a silver lining; those clinical colleagues who once did not even know that there was a research facility in Glasgow, now come to us to ask advice about delivering medicines; we are asked questions about research as we enter wards and potential participants are suggested to us, having spiked the interest of our nursing colleagues. That lesser known speciality of research nursing is now on the map. Let us keep it there!

When it was announced that the Nursing and Midwifery Council had introduced emergency standards ( Nursing & Midwifery Council, 2021 ) at the request of the UK government to allow student nurses to support the NHS without being supernumerary during the first wave of the pandemic, I was scared. I was concerned that foregoing my supernumerary status would be a detriment to my education. The decision to be made, whether to ‘opt in or opt out’, was a difficult one. Opting in meant a potential negative impact to my learning and risking my family’s health with this unknown trajectory of this new disease. But opting out meant that my final year as a student nurse would be extremely pressured to make up the 380 hours alongside theory and the year 3 hours that already had to be completed. I was conflicted in my decision making, but I decided that ‘opting-in’ was the right decision for me.

Due to the emergency, our placement was brought forward by 3 weeks which involved my university, Glasgow Caledonian University, having their staff work around the clock to meet the demands of the NHS, along with the constant demands from students who were anxious about what the emergency standards meant to them. It was not an easy task; however, they did an amazing job showing impressive teamworking. I was allocated Glasgow Clinical Research Facility (GCRF) as my placement.

Whilst student nurses understand that research in nursing is a professional obligation of the Nursing and Midwifery Council (2018) , it is well documented that evidence-based practice theory modules are challenging for student nurses as they find it irrelevant to practice ( Ferguson et al., 2017 ). Therefore, I was apprehensive as to what learning opportunities this placement would provide and, importantly, if I would be able to meet the essential skills cluster requirements to be signed off as a year 2 student.

Upon my arrival, it was clear that the team members were enthusiastic about my placement. My allocated mentor spent time with me to build a mutually respectful relationship and discuss what knowledge and skills I had and what I wanted to achieve from this placement. This person-centred approach allowed me to flourish and gain confidence as a year 2 student. Throughout the whole time at the GCRF, I was provided with continuous constructive feedback and constant revisiting of the goals we set for my learning which is an essential component in any clinical learning environment ( Jefford et al., 2021 ).

Clinical Research Nurses (CRNs) are extremely adaptable and have an advanced knowledge base. They act as advocates to preserve patient safety whilst ensuring the integrity of the research they carry out. It was also evident that CRNs use a holistic approach to critically assess the research needs rather than have a task-orientated approach.

During my time at the GCRF, I was able to learn about the trajectory of the COVID-19 disease through analysing the data, observe participant recruitment for the drug trials that may help treat symptoms or reduce the impact of the virus and help trial the efficacy of the Oxford AstraZeneca vaccine.

These trials helped me understand the importance of good documentation, the challenges that come with consenting for participants who are unable to consent due to their illness and the ethical decisions that doctors and CRNs face. I was also involved in collecting biological samples and clinical and demographic data. I also received additional training on Good Clinical Practice, basic life support, anaphylaxis and intra-muscular injections. Additionally, I saw first-hand the infection prevention and control (IPC) innovations the CRN’s were able to implement in order to continue research protocols taking place which Iles-Smith (2020) attests are essential skills for the flexibility and contingency planning in times of public health emergencies.

This placement enabled me to be more curious, think critically, be adaptive and innovative which are all essential attributes of being a nurse. Being part of such a positive culture which nurtures students helped me to bridge the gap between theory and practice in terms of evidence-based practice. I did not apply to do a nursing degree with the intention to be involved in research; I applied as I wanted to make a positive impact on patients’ lives. However, it was unmistakable from this placement that CRNs play a huge part in this too. This placement mitigated my initial concerns about being a detriment to my learning, and in fact, it has enhanced it. Offering student nurses more research placements in order that pre-registration students’ perceptions of research are changed ( Council of Deans of Health, 2019 ) will produce research confident students nurses who understand the significance of research and feel empowered to use it to improve patient outcomes.

Editors’ note

Together, these two perspectives illuminate the impact that COVID-19 had on research activity and a strong insight into the contribution CRNs made to the international endeavour to understand the disease, identify effective treatments and support the development of the vaccine. This was undoubtedly a challenging period that demanded strong leadership, adaptability and the development of an environment and culture that facilitated innovative solutions. Whilst the authors describe the experience in one research facility in Scotland, we feel sure their perspectives will resonate more widely, and hopefully reflect the emphasis placed on greater innovation and flexibility within clinical research and higher education.

Leeanne Milne is a senior research nurse in GCRF and has been involved in education initiatives in the unit. She has recently moved post to a clinical educator role with Older People and Stroke Services in NHS Greater Glasgow and Clyde.

Hillary Peddie has many years’ experience in clinical research nursing and manages the Diabetes and Respiratory teams in GCRF.

Naomi Hickey has been involved in research as a research nurse and educator for over 10 years and has developed a comprehensive training programme in GCRF to support new research nurses.

Natalie Elliott is undertaking an optional fourth year to the nursing programme at Glasgow Caledonian University. She is currently working as a Registered Nurse and aspires to gain employment as a Clinical Research Nurse.

Authors’ Note: This perspective is presented in two parts. In the first, three clinical research nurses from the Glasgow Clinical Research Facility (GCRF) reflect on the impact of the COVID-19 pandemic on their clinical and research practice. In the second part, a student nurse deployed to the GCRF reflects on her experience offering a complementary perspective.

• Council of Deans of Health (2019). Becoming research confident. Research in pre-registration curricula for nursing, midwifery and allied health programmes in the UK . London: Council of Deans of Health. Available at: https://councilofdeans.org.uk/wp-content/uploads/2019/05/CODH.RIPR_.report_v3-002.pdf [ Google Scholar ]
• Ferguson C, Digiacomo M, Gholizadeh L, et al. (2017) The integration and evaluation of a social-media facilitated journal club to enhance the student learning experience of evidence-based practice: A case study . Nurse Education Today 48 : 123–128. DOI: 10.1016/j.nedt.2016.10.002 10.1016/j.nedt.2016.10.002 [ PubMed ] [ CrossRef ] [ CrossRef ] [ Google Scholar ]
• Iles-Smith H. (2020) How research nurses and midwives are supporting Covid-19 clinical trials . Nursing Times 116 ( 11 ): 20–22. https://www.nursingtimes.net/roles/clinical-research-nurses/how-research-nurses-and-midwives-are-supporting-covid-19-clinical-trials-06-10-2020/ [ Google Scholar ]
• Jefford E, Nolan S, Munn J, et al. (2021) What matters, what is valued and what is important in mentorship through the appreciative inquiry process of co-created knowledge . Nurse Education Today 99 : 104791. DOI: 10.1016/j.nedt.2021.104791 10.1016/j.nedt.2021.104791 [ PubMed ] [ CrossRef ] [ CrossRef ] [ Google Scholar ]
• Nursing & Midwifery Council (2018) The Code [online] . London: Nursing & Midwifery Council. Available at: https://www.nmc.org.uk/standards/code/ (accessed 21 January 2021). [ Google Scholar ]
• Nursing & Midwifery Council (2021) Current emergency and recovery programme standards. [online] . London: Nursing & Midwifery Council. Available at: https://www.nmc.org.uk/globalassets/sitedocuments/education-standards/current-emergency-and-recovery-programme-standards.pdf (accessed 25 February 2021). [ Google Scholar ]

Clinical Life Sciences and Biotechnology

As one of the largest life sciences clusters in Europe, Scotland is the home of ground-breaking research and invention in human healthcare and technology. 

Employing...

over 41,000 people across 770 organisations.

Contributing...

£2.4bn in GVA to the Scottish economy.

Glasgow’s thriving Life Sciences sector, underpinned by a robust partnership of academia, industry and the NHS, provides ideal conditions for health innovation to flourish.

With four universities, the  largest acute hospital complex  in Western Europe and a world-leading talent pool, the region produces and attracts international leaders in precision medicine, medical technology, and translational medicine.

Led by the prestigious University of Glasgow, the city is now a world leading and business-friendly centre for precision medicine and imaging, providing unique access to ‘cradle to grave’ electronic patient records and data, easy access to clinical trial infrastructure, partner identification, logistical and financial support.

In dealing with the COVID-19 pandemic, Glasgow City Region has drawn on strengths in research, innovation and entrepreneurship to help tackle new societal challenges and provide a platform to recover and re-build.

The collective response across the city region has been remarkable, with multidisciplinary approaches to collaborate across the public, private and academic sectors to deliver results at pace.

Click here to explore the breadth and depth of regional activity .

More than 380 Life Sciences companies…

in the Glasgow city region turn over £325m annually, employ over 10,000 people and represent over one third of Scotland’s total sector base (incl. 50% of MedTech companies).

Glasgow is one of only 12 major European cities…

to boast a global top 50 university for Life Sciences.

The £1bn Queen Elizabeth University Hospital…

developed in partnership between NHS Greater Glasgow and University of Glasgow, is the largest critical care complex in Western Europe.

Regional strengths

Glasgow, its universities, research institutes and hospitals sit at the heart of the city region, underpinned by a robust and innovative partnership across industry, academia and the public sector and supported by a well-established and complex supply chain.

The Glasgow Lighthouse Lab, operated by the University of Glasgow on behalf of the UK Government, has played a vital role in identifying positive COVID-19 cases and helping reduce transmission of the virus since starting operations in April 2020.

Staffed around the clock, more than 20m PCR tests from across the UK have been analysed at the lab to date, with many tests genomically sequenced to identify and track any new variants.

The region is also home to world-class R&D centres of excellence, including the University of Glasgow-led Imaging Centre of Excellence (ICE), Clinical Innovation Zone , and the Precision Medicine Scotland Innovation Centre (PMS-IC) at the Queen Elizabeth University Hospital (QEUH) site.

The PMS-IC brings together industry innovators, clinicians and world-class researchers to collaborate on Precision Medicine opportunities. It focuses on linking Scotland’s domain expertise, data assets and delivery capability to accelerate the adoption of new products and services for a global market. The Innovation Centre was established by a consortium of partners from 4 Scottish NHS Health Boards, 4 Scottish Universities and 2 industrial partners in informatics: Aridhia Ltd and in genetics with ThermoFisher Scientific Ltd .

The quality of research from the four Precision Medicine Scotland-Innovation Centre partner universities in precision medicine related subjects is higher than in other key university groupings in the UK.

Health innovation in the region is further supported by world-class infrastructure and facilities, including novel imaging technology and access to a patient base of 2.8m.

The £56m Medicines Manufacturing Innovation Centre , in partnership with the University of Strathclyde, will accelerate adoption of novel manufacturing technologies for small molecule pharmaceuticals and fine high value chemicals. The region is also home to one of the largest pathology laboratories in Europe and a large biorepository for high-quality clinical samples.

Previous research by Scottish Enterprise has indicated 30% of all the biosafety testing across Europe is done in Glasgow. SGS Vitrology , the world’s leading inspection, verification, testing and certification company, is a topical example of Glasgow’s distinct strengths. From the onset of the pandemic, SGS has batch developed and tested over 1 billion doses of COVID-19 vaccine for clinical trial.

The biosafety testing market is itself part of the wider “Pharmaceutical Services” sub-sector where the City Region in particular excels, by providing contract research services and the supply of key components of the supply chain.

Cluster strengths

The Glasgow BioCorridor ─ a biomedical cluster linking industry with public sector and academia ─ houses more than 380 life sciences companies, representing over a third of all life sciences enterprises and medtech companies in Scotland. Almost 75% of life sciences activity involves human healthcare and more than 25% of the region’s top innovative technology firms are in the health and medical sectors, higher than in Manchester, Liverpool and Leeds.

Precision medicine is changing the way we think about health problems with a new generation of healthcare delivery which signifies a movement away from a one-size-fits-all approach to medical care, tailoring medical diagnosis and treatment to individual characteristics of patients. Companies can capitalise on Glasgow city region’s strengths in the sector to launch their precision medicine application in the UK, Europe and globally. The global precision medicine market across major diseases is forecast to grow to £102bn by 2025.

Technologies which are transforming healthcare delivery, accelerated by the COVID-19 pandemic, include mobile and app-based technologies, wearable devices, how public health messages are both rapidly and effectively communicated, and the analysis and interpretation of data. In 2024, the total medical technology revenue globally is expected be nearly £450bn. Medical technology is used for diagnosis, monitoring, or treatment of diseases or medical conditions.

Assets and infrastructure

Queen elizabeth university hospital campus.

The Queen Elizabeth University Hospital Campus is the largest critical care complex in Western Europe, puts Glasgow at the forefront of healthcare and innovation across the UK and Europe.

The 14 floor building is one of the largest acute hospitals in the UK and home to major specialist services such as renal medicine, transplantation and vascular surgery, with state-of-the-art Critical Care, Theatre and Diagnostic Services.

Precision Medicine Scotland Innovation Centre

The Precision Medicine Scotland Innovation Centre  enables the development of new products and services for a global market via its platform for collaboration linking Scotland’s expertise, data assets and delivery infrastructure to accelerate the real-world adoption of precision medicine including incubator units for industry.

The Living Laboratory

The Living Laboratory for Precision Medicine, with funding from UKRI Strength in Places Fund, is an internationally leading programme focused on translating cutting-edge science and healthcare innovation into real-world clinical settings. Integrated within the Queen Elizabeth University Hospital campus, the Living Laboratory expands upon Glasgow’s award-winning precision medicine industry cluster to realise the full potential and benefit of precision medicine.   

The Living Laboratory will be a focal point for research and development, open innovation and commercialisation – bringing partners from across the triple helix together to unlock substantial productivity growth opportunities. Delivering expert support for industry, access to a supportive ecosystem and unique infrastructure, the Living Laboratory enables the testing of new innovations in clinical settings, accelerating the adoption of precision medicine innovations into healthcare to deliver savings for the NHS, improve health outcomes and drive economic development in Govan, Glasgow, and beyond.  

Imaging Centre of Excellence (ICE)

The Imaging Centre of Excellence (ICE) houses the UK’s first ultra-high field 7 Tesla (7T) MRI scanner, fully integrated within a clinical site. ICE also links to world leading 3T and CT imaging clinical research facilities, transforming Glasgow’s capacity to deliver leadership internationally in imaging and precision medicine.  

Glasgow Clinical Research Facility

The Glasgow Clinical Research Facility is led by the University of Glasgow and NHS Greater Glasgow and Clyde for trials in adults and children. Employing over 60 staff, the CRF works closely with NHS researchers, academic partners, contract research organisations, pharmaceutical and medical device companies.

The University of Glasgow Clinical Innovation Zone

The University of Glasgow Clinical Innovation Zone is based at the Queen Elizabeth University Hospital and a designated member of the United Kingdom Science Park Association, comprising of 22,000 ft2 of space designed to foster open innovation across the collaborative ‘triple-helix’ partnership, between the University, industry and NHS. Co-located industry partners within the CIZ include Aridhia, Clinnovate Health, Siemens Healthineers, MR CoilTech, Causeway Therapeutics, BioClavis, Canon Medical Systems and Spiritus.

Queen Elizabeth University Hospital Learning and Teaching Centre

The Queen Elizabeth University Hospital Learning and Teaching Centre is a purpose-built facility developed and managed in partnership between the University of Glasgow and NHS Greater Glasgow and Clyde on the Queen Elizabeth University Hospital campus.

The University of Strathclyde: Institute of Medical Devices

The University of Strathclyde is exemplary in medicines, medical devices and diagnostics. The Strathclyde Institute of Medical Devices brings together specialists in engineering, life sciences, physical sciences and the NHS to research and innovate future technologies and assist MedTech companies and their supply chain to enter the global MedTech market.

Digital Health & Care Innovation Centre

Led by a world-leading partnership between the Glasgow School of Art and the University of Strathclyde, the Digital Health & Care Innovation Centre supports transformational collaboration between universities and businesses. The innovation centre can help you to develop prototypes and take them to market, as well as offering a demonstration and simulation environment alongside living lab test beds.

iCAIRD is the Industrial Centre for Artificial Intelligence Research in Digital Diagnostics.

CENSIS is Scotland's Innovation Centre for sensing, imaging and Internet of Things (IoT) technologies. CENSIS work with all types of organisations, from large multinationals and public sector bodies, to SMEs, including high tech, pre-revenue start-ups.  They also support collaborative R&D projects and industrial PhDs to both develop the skills base and generate new technologies.

Health and Care Futures

Health and Care Futures  uses state-of-the-art innovation and expertise to promote the delivery of new models of care focusing on prevention, and empowering individuals and populations to live as well as possible at home and in their communities.

Scotland has a well-established ecosystem for precision medicine centred around the Scottish Government’s investment in the Precision Medicine Scotland Innovation Centre and the QEUH. The combination of world-class clinical research, electronic health data, patient samples, NHS and large cohorts of patients with chronic disease differentiates Scotland from many other countries.

— Professor Victor Dzau, President of US National Academy of Medicine.

We are pleased to contribute to Scotland’s health and economic growth, now and beyond the pandemic.

— LumiraDx Chief Executive Ron Zwanziger

Scottish Enterprise has worked closely with the company in Scotland, Europe, US and Japan to provide business support. This has included work from SDI field colleagues in Japan and across Europe to help identify potential customers, as well as tailored company support on the ground in Scotland to look at new market opportunities globally and extend existing testing services.

— Dr David Bunton, CEO of ReproCELL Europe Ltd

Technology and Innovation Centre (TIC)

The University of Strathclyde’s TIC is home to 850 academics working in partnership with industry tenants focusing on key themes including health technologies and disease management.

Kadans - West of Scotland Science Park

Kadans is home to a wide range of companies operating across all areas of the life sciences and technology sectors including ultrasonics, pharmaceuticals, mobile computing, cleanrooms, satellites, laser systems, telecommunications, pre-clinical drug discovery and optolectronics.  In close proximity to several leading research facilities including the Beatson Oncology Centre, one of Europe’s top cancer hospitals, and the new Translational Research Centre, the final element in the Glasgow Centre for Cancer Research.

Biocity Glasgow

Biocity Glasgow is a 20-biotech incubator with specialist industry facilities including a compound management library and GMP storage and archiving. Home to a growing number of dynamic, successful and growing technologies.

Medicity Glasgow

Medicity Glasgow is a subsidiary of the BioCity Group offers the ideal environment for both start-up and established MedTech and digital health companies to grow. It provides flexible lab and office space, accelerator bootcamps and events.

Glasgow Riverside Innovation District

Glasgow Riverside Innovation District (GRID) is a partnership between the University of Glasgow, Scottish Enterprise and Glasgow City Council. Its aim is to areate an environment to boost collaborations with industry and encourage the formation of new ones in some of the most dynamic sectors of the economy.

The Living Laboratory and Clyde Waterfront Innovation Campus (CWIC) are both part of GRID. CWIC brings together academic research strengths and unique translational asset with cutting-edge facilities and industrial R&D teams to create an ecosystem offering opportunities for interdisciplinary collaboration, innovation and skills development.

Industry support

The Life Sciences Scotland Industry Leadership Group (LSS ILG) is a joint industry, enterprise of agencies and government strategy teams. Their remit is to develop, drive and deliver the Life Sciences strategy in Scotland.

The Life Sciences Scotland Company Directory lists over 1000 companies and organisations in the life and chemical sciences sector in Scotland. It doesn't only include companies but also academic organisations, research centres and trade associations.

SULSA is a strategic partnership between eleven Scottish Universities that aims to advance Scotland’s research and innovation in the life sciences, and secure Scotland’s global position as a world-class centre of research excellence.

Glasgow city region’s well-established precision medicine ecosystem can support your business with:

• Extensive data records and real time patient data
• Internationally renowned clinical trial infrastructure
• Connectivity and coordination across academia, industry and healthcare

Company Focus

Precision medicine.

• Gabriel Precision Oncology Laboratory
• Thermo Fisher Scientific
• Siemens Healthineers

Medical Devices and Diagnostics

• MR Coiltech
• Alba Ultrasound
• Intellego Technologies

Digital Health

• Aridhia Informatics
• Metix Medical
• Pal Technologies
• Frog Systems

Pharmaceutical Services

• SGS Vitrology
• Tissue Solutions
• Amphista Therapeutics
• TC Biopharm
• Causeway Therapeutics
• Antibody Analytics

Clinical Manufacturing

• Merck Life Sciences
• Enterobiotix
• Curia Scotland

Both Universities of Strathclyde and Glasgow…

ranked in the top 16 institutions for producing spin-out companies in 2021 with 38 and 29 respectively.

Research & Development

Drive your research forward through collaboration with the region’s leading global universities.

Every Scottish university was found to undertake research deemed “world-leading” in the latest UK benchmarking exercise. Scottish universities also have the highest number of publications per researcher across all UK nations and EU nations of similar size – 0.53 in Scotland vs 0.43 in Sweden and 0.38 in UK, and the highest average number of citations per researcher in these countries.

Scottish Universities were awarded 13% (£450m)…

of all UK funding through Biotechnology and Biological Sciences Research Council and Medical Research Council over the last 5 years.

Scottish universities also generated…

the second highest income in collaborative research with industry in 2018/19 across all UK regions.

In Glasgow, there are many types of investment, funding, and grant options open to companies in the life sciences sector. Scottish Enterprise, Scotland’s national development agency, can provide access to its Growth Investment Team who invest in and support early-stage companies access a range of finance including bank funding, equity funding, loans and grants.

Scottish Co-Investment Fund

Gap equity funding of between £10,000 and £1.5m matched by an accredited investment partner.

Scottish Venture Fund

Gap funding up to 50% of total funding package between £10,000 and £2m.

Scottish National Investment Bank

A mission-led development bank providing patient capital to build a stronger, fairer, more sustainable Scotland. It invests in debt and equity on commercial terms based on project or business needs.

Venture Capital Fund

A £102m fund, led by Epidarex Capital, for early stage, high growth, life science and health technology companies. The UK Government has committed £50m through the British Business Bank, with the rest coming from the Universities of Edinburgh, Manchester, Glasgow and Aberdeen, Strathclyde Pension Fund and several global investors.

Talent Pipeline

Glasgow’s leading institutions are developing a pipeline of talent for your business now and in the future.

Wth access to the very best talent pool, the city is home to over 8,000 health and life sciences students - the highest of all 11 UK core cities - and feeds an established industry workforce in excess of 10,000 people .

The city region graduate pool in particular is strengthened by precision medicine-specific courses and world-class research centres.

The University of Glasgow houses Scotland’s imaging and precision medicine centres of excellence (ICE and PMS-IC), iCAIRD and the £98m precision medicine Living Lab. The university also awards a postgraduate Masters course in Precision Medicine and Pharmacological Innovation, and the MRC Doctoral Training Programme in Precision Medicine.

The University of Strathclyde is exemplary in medicines, medical devices and diagnostics, partnered with the £56m Medicines Manufacturing Innovation Centre in Renfrewshire. The University also houses the Digital Health and Care Institute (DHI).

Sector News

Read all the latest Life Science news in and around Scotland:

• Life Sciences Scotland News

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Clinical Research Facilities

NIHR’s 28 Clinical Research Facilities (CRFs) are purpose-built facilities in NHS hospitals where researchers can deliver early-phase and complex experimental studies. They offer a range of services to help researchers and life science organisations to design and deliver these clinical trials.

What are the NIHR Clinical Research Facilities?

NIHR 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. 

The NIHR has invested £161 million in these facilities across England, creating cutting-edge facilities for complex studies, including overnight studies.

Where are the NIHR CRFs located?

Our 28 CRFs are distributed across England. These are:

• NIHR Alder Hey Clinical Research Facility
• NIHR Barts Clinical Research Facility 
• NIHR Birmingham Clinical Research Facility
• NIHR Bristol Clinical Research Facility
• NIHR Cambridge Clinical Research Facility
• NIHR Exeter Clinical Research Facility
• NIHR Great Ormond Street Hospital Clinical Research Facility
• NIHR Guy’s and St Thomas’ Clinical Research Facility
• NIHR Imperial Clinical Research Facility
• NIHR Lancashire Clinical Research Facility
• NIHR Leeds Clinical Research Facility
• NIHR Leicester Clinical Research Facility
• NIHR Liverpool Clinical Research Facility
• NIHR Manchester Clinical Research Facility
• NIHR Moorfields Clinical Research Facility
• NIHR Newcastle Clinical Research Facility
• NIHR Norfolk Clinical Research Facility
• NIHR Nottingham Clinical Research Facility
• NIHR Oxford Clinical Research Facility
• NIHR Oxford Health Clinical Research Facility
• NIHR Royal Free Clinical Research Facility
• NIHR The Royal Marsden Clinical Research Facility
• NIHR Royal Surrey Clinical Research Facility
• NIHR Sheffield Clinical Research Facility
• NIHR Southampton Clinical Research Facility
• NIHR King's Clinical Research Facility
• NIHR St George's Clinical Research Facility 
• NIHR UCLH Clinical Research Facility

All CRFs in England and the devolved administrations are supported by the UKCRF Network. The UKCRF Network is funded by the NIHR and it facilitates collaboration among CRFs, providing strategic leadership to create an internationally competitive network of early-phase facilities in the UK.

This networks enables:

• coordination of CRFs into a national early phase research delivery platform
• access to highly skilled research delivery staff
• development and sharing of best practice guidance and tools
• provision of support for patient involvement and access to early phase research

What services do the NIHR CRFs provide?

The CRF teams have a proven track record of helping to deliver a wide range of research. Researchers funded by the NIHR, the life sciences industry and other organisations can access assistance from skilled CRF clinical trial support staff, from study design to data collection and study management. This includes specialist world-leading expertise in specific therapeutic areas, highly specialised equipment and facilities, access to patient populations and patient and public advocates. 

In 2022 to 2023, our CRFs collectively supported 1,774 active commercial studies.

How do CRFs support research?

CRFs receive sustained funding from the NIHR to deliver both commercial and non-commercial, early translational and experimental medicine research.

The CRFs can:

• provide state of the art facilities to support the delivery of high-intensity research,tailored to each CRF’s therapeutic specialisms such as laboratories for sample processing, clinical trials pharmacies, radiopharmacies, sleep clinics, cardiorespiratory exercise and hypertension testing suite, a pan-endoscopy suite, in-patient isolation rooms, and more
• offer a critical mass of dedicated and highly-skilled clinical staff, scientists and academics, who have specialist expertise in the delivery of experimental medicine and high intensity studies
• help capacity building through training and development opportunities
• provide opportunities to leverage and attract funding from external organisations, forming key strategic partnerships through industry engagement
• engage participants across a wide range of conditions, developing inclusive recruitment strategies to target specific patient populations
• connect and collaborate with networks of patients and volunteers who help in the design of patient-centric research
• offer access to project management and data collection expertise, and a diverse workforce of experience research nurses, to aid study delivery

CRF support for the life sciences industry

In addition to working with NHS and university-led research teams, CRFs have extensive experience of working with commercial companies, from biotechnology and medical technology startups to prominent pharmaceutical giants.

Companies that choose to work with NIHR CRFs can access all of the support for research listed above. This support is available to both commercial and non-commercial research studies.

Life science organisations and sponsors of commercial research should contact the NIHR industry team to discuss their requirements and explore which facility would be best suited to support them.

Contact the Industry team

Visit our ‘ Offer to the Life Sciences Industry ’ page to discover the full range of support available to commercial research sponsors developing and delivering research in the UK.

Register to take part in a study today

Pioneers in Neuro Clinical Research

Now recruiting volunteers for Parkinson’s research.

NeuroClin Glasgow is an independent research organisation engaged in national and international clinical studies that seek to find better treatments for those with memory impairment, Alzheimer’s Disease, Parkinson’s, Dementia, Depression and other neurological conditions.

We are currently accepting applicants across Scotland for research studies into Alzheimer’s disease, Parkinson’s disease and Depression.

Register for yourself or on behalf of someone else to take part

Please select the relevant pre-screener

NeuroClin Glasgow

We are an independent research organisation, engaged in National and International research studies that seek to find better treatments for those with Memory Impairment, Alzheimer’s disease, Dementia, Parkinson’s disease, Depression and other neurological conditions.

Our dedicated research facility is located within Excel House, at Eurocentral and our team are experienced healthcare professionals who have now dedicated their time to research.

Watch our latest STV advert

Our areas of current research.

Learn more about the symptoms which affect these conditions.

Alzheimer’s

Parkinson’s

Memory Impairment

Current Studies

We have a number of national and international clinical studies running for those seeking to find better treatments specifically with memory impairment, Alzheimer’s disease, dementia, Parkinson’s disease, Depression and other neurological conditions.

We are currently accepting applicants from across Scotland for research studies. If you’d like to learn more about current opportunities or qualifying criteria, please call us on 0141 948 0206 and a member of our team will be happy to answer your enquiry.

People who qualify for each of these studies will receive:

Benefits of Research

What are the benefits of participating in a clinical trial?

New Treatments

Access to promising new treatments often not available outside the clinical-trial setting.

Effective Treatments

Treatment that may be more effective than the standard approach.

On going Support

Close monitoring, advice, care, and support by a research team of doctors and other health care professionals who understand your disease or condition.

Priority Listing

The opportunity to be the first to benefit from a new method under study.

Further Knowledge

The chance to play an active role in your own health care and gain a greater understanding of your disease or condition.

Being part of research

The chance to help society by contributing to medical research. People who take part in clinical trials are vital to the process of improving medical care.

If you would like to learn more about the benefits of volunteering to take part in a clinical trial, please click below:

Testimonials.

During my period attending the clinic I found a very congenial atmosphere and was most impressed with the staff’s attitude and dedication at all times.

George Harrison - Paisley

A very positive experience – I was reassured to discover that my memory was too good for the research study.

J C - Glasgow

Latest News

Browse through our recent news and keep up to date with the latest on what’s been happening at NeuroClin Glasgow.

NeuroClin appoints new chief executive

Plans also unveiled for a new site in north west England during the third quarter. NeuroClin has appointed Fiona Wood as its new chief executive. The Glasgow-headquartered clinical research facility has also confirmed that an agreement has been reached to open a new site in north west England this autumn.Wood joins the business from Clyde … Continued

NeuroClin and Dementia Action Week 2024: Together Towards Better Diagnosis

This week Neuroclin marks the commencement of Dementia Action Week, running from 13th to 19th May 2024. Spearheaded by the Alzheimer’s Society, this initiative seeks to mobilise the UK in significantly enhancing the diagnosis rates of dementia. It’s a stark reality that 1 in 3 people living with dementia are undiagnosed, underlining the critical importance … Continued

How Dementia Affects Women Differently

With women being 65 per cent of the people affected by dementia, we must make sure that any new therapy works for them as well as men.

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NRS Introduction to Good Clinical Practice (GCP)

There are no fees for NHS Greater Glasgow and Clyde/NHS West Node employees

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The Research and Innovation Service in NHS Greater Glasgow and Clyde operates to support researchers in the NHS and academia. It has multiple roles including offering consultancy and advice, providing Management Approval and aiding in the achievement of a successful conclusion to research projects.

Our goal is to release the potential to world class clinical studies across the region, and to play our part in enabling Scotland to grow as an internationally competitive location for medical research.

The Research and Innovation management office acts as a catalyst for discovery and innovation within NHSGGC. We have a ‘can-do’ attitude, striving to support both experienced and new researchers in the design and execution of high quality research studies and ensure compliance to all regulatory requirements.

As the busiest Research and Innovation office in Scotland, we received in excess of 560 new research applications in 2023 and have approximately 1000 studies ongoing at any one time.

To ensure consistency of contact, and to help develop an in-depth understanding of therapy area-specific research projects, the NHSGGC Research and Innovation Management office has adopted a ‘portfolio-team’ structure. The portfolio teams form the functional core of Research and Innovation and are comprised of Research Co-ordinators, Research Facilitators, Co-ordinator’s Assistants and clerical support staff.

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Based at the AHRO University at Glasgow, the AHRO Clinical Research Facility (ACRF) is a purpose-built clinical area dedicated to research trials. It also houses the evidence-based medicine research team.

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All studies undertaken within the clinical research facility are conducted to the highest standards of safety that comply with up to date and relevant regulations and ethical guidelines. All our activities conform to the well delivered standard operating procedures. All staff are provided with training which are relevant to their specific roles.

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COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

Clinical Research Coordinator I - DLD

• Columbia University Medical Center
• Opening on: Aug 12 2024
• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $63,700 - $75,000

Position Summary

We are seeking a Clinical Research Coordinator to join the Division of Digestive & Liver Disease within the Department of Medicine at CUIMC. This role will be instrumental in coordinating the research activities of multiple ongoing projects, including NIH/NCI grant-funded studies and industry-sponsored clinical trials. Our research focuses on upper gastrointestinal diseases, the microbiome's impact on GI disease development and progression, and the implementation of innovative screening methods for GI conditions.

Responsibilities

• Oversee and maintain active IRB approval for assigned research protocols, submitting modifications and renewals as required.
• Foster effective communication with the study team, research sites, and sponsors to ensure timely updates on protocol changes and study status.
• Screen medical records to identify eligible participants based on specific inclusion and exclusion criteria. Contact potential participants to enroll them in the study.
• Conduct study visits, administer questionnaires, collect and handle biological specimens, and maintain accurate and up-to-date research records and databases.
• Serve as the primary point of contact for research participants, addressing inquiries, providing updates, and ensuring their satisfaction.
• Work closely with departmental research personnel and other CUIMC departments, including Sponsored Projects Administration and the Clinical Trials Office.
• Report directly to the Clinical Research Manager of the DLD research team and Principal Investigators of relevant studies.
• Perform additional related duties as needed.

Minimum Qualifications

• Requires a bachelor's degree or equivalent in education, training and experience, plus three years of related experience.
• Minimum of two years of experience in a clinical research setting.

Preferred Qualifications

• Bilingual (Spanish).
• Experience in clinical settings, IRB submissions, GCP and HSP principles, and HIPAA regulations.

Other Requirements

• Contact with patients and/or human research subjects
• Potential bloodborne pathogen exposure
• Successful completion of applicable compliance and systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity 

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds.  , share this job.

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Iscoe Receives YCCI Scholar Award for AI Research on Drug Reactions

Mark Iscoe, MD, MHS , has received a Yale Center for Clinical Investigation (YCCI) Scholar Award to research adverse drug reactions (ADRs) using large language models and artificial intelligence (AI). Iscoe is assistant professor of emergency medicine and of biomedical informatics and data science at Yale School of Medicine.

Defined as harmful and unintended responses to medications, ADRs often lead to emergency department (ED) visits and hospitalizations among older adults. ADRs typically present in nonspecific ways, such as dizziness, falls and altered mental status, which means the role of medications can be overlooked by emergency physicians—placing patients at risk of preventable harm. Research in this area has been limited, according to Iscoe, because many clinicians report suspected ADRs through unstructured clinical notes rather than structured data and diagnostic codes.

Iscoe’s project, titled “Identifying Adverse Drug Reactions Among Older Adult Emergency Department Patients with Undifferentiated Presentations Using Large Language Models: A Stakeholder-Engaged Project,” aims to address this issue. The study team will use AI methods, such as natural language processing and large language models, to perform large-scale analyses of previously inaccessible clinical notes.

“[The project will] fill gaps in our current knowledge of the scope and nature of adverse drug reactions in older adult ED patients with undifferentiated presentations—as well as opportunities and barriers to addressing them,” said Iscoe. “We hope this project will pave the way for a future [clinical decision support] intervention that will improve diagnostic safety, facilitate appropriate deprescribing, and improve patient-centered outcomes.”

Iscoe’s collaborators include Ula Hwang, MD, MPH , adjunct professor of emergency medicine, Andrew Taylor, MD, MHS , associate professor of emergency medicine and of biomedical informatics and data science, Terri Fried, MD , Humana Foundation Professor of Medicine (Geriatrics), and Arjun Venkatesh, MD, MBA, MHS , professor and chair of emergency medicine.

The YCCI Scholar Award is awarded to junior faculty members who are strongly committed to research careers focused on improving human health.

The award offers salary support in addition to research funding of $25,000 for two years.

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Featured in this article

• Mark Iscoe, MD, MHS Assistant Professor of Emergency Medicine and Biomedical Informatics and Data Science
• Ula Hwang, MD, MPH Professor Adjunct of Emergency Medicine
• Terri Fried, MD Humana Foundation Professor of Medicine (Geriatrics); Section Chief, Geriatric Medicine
• Arjun Venkatesh, MD, MBA, MHS Professor of Emergency Medicine; Chair, Emergency Medicine; Scientist, Center for Outcomes Research and Evaluation, Internal Medicine

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Filter by month, filter by course, nrs introduction to good clinical practice (gcp), nrs good clinical practice (gcp) update, principal investigator roles and responsibilities workshop, bite size training - investigational medicinal products, bite size training - quality and monitoring in research trials, bite size training - getting started in a research trial, bite size training - delivering a research trial, bite size training - the who's who of research and innovation, bite size training - trial design, ctimp workshop, early phase clinical trial, good research practice (non-drug trials), informed consent - adults: ethical, legal and practical aspects in clinical research, induction one: clinical research 101: diving into research essentials, induction two: safe and sound: ensuring excellent research evidence, induction three: in pursuit of perfection: delivering quality research, laboratory skills workshop, medical device good research practice, paediatric consent - the practicalities and legalities in taking consent for paediatric trials, preparing poster & presentations, introduction to critical appraisal.

The Education team works closely with our partners in the NHS, Higher Education Institutes and Research & Development departments to provide a service that is tailored to meet the needs of researchers and associated staff.

We collaborate with education staff in CRF's across the UK and with colleagues at the NIHR to ensure a cohesive and standardised programme of educational opportunities are available to researchers.

If you have any questions regarding the education programme or a course you have booked, please contact  [email protected]  or 0141 314 0206.

Glasgow Clinical Research Facility privacy statement

______________________________________________

This one day course is designed either for those who have not studied Good Clinical Practice (GCP) before or those who have studied it more than two years ago. It is presented as a practical introduction to the subject and consists of a mixture of short lectures interspersed with practical activities, culminating in a monitoring workshop. The monitoring workshop allows the more abstract concepts that have been discussed throughout the day to be brought to life.

While the principles of GCP that are covered in the course are common to a wide range of different types of clinical research the course does focus on the drug trial specific legislation. However, it also promotes the ‘GCP-mindset’ needed to satisfy inspectors and auditors, and would therefore be useful for all clinical researchers.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors. 

Pricing Information:

Invoice Detail:

Please note confirmation of course will be sent once a purchase order number has been provided .

Pay by Card

Please contact our Treasury Department with the name of course and course date - 0141 278 2794

This course is relevant for those who are conducting or supporting Clinical Trials of an Investigational Medicinal Products (CTIMPs) and who have previously undertaken a GCP course. It is suitable for those who require an update to provide evidence of having maintained and updated their knowledge of GCP. Attendance at the half day update course requires you to have undertaken GCP training within the past two years. The course is compliant with Transcelerate requirements.

Topics include

• UK legislation – Statutory Instrument
• What’s new in regulations and frameworks
• Quality Systems
• Record Keeping
• Safety Reporting
• Computer System Validation
• Principles of GCP

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

The aim of this workshop is to equip Principal Investigators and researchers with an understanding of the key roles and responsibilities involved in conducting a research trial. The workshop will consist of a mixture of presentations and discussions.  It is relevant to those who are new to research and for those who would like to improve their understanding of set up, coordination and archiving of research trials.

After the Workshop, each Participant will:

• understand the requirements of a Principal Investigator in research studies
• understand the importance of study oversight and how to demonstrate this
• describe the key steps of study set up and recognise important contacts
• understand the role of the PI in leading the study team and overseeing trial activities
• recognise the key steps for archiving a research trial

Pay by Cheque: please make out a cheque, payable to NHS GG&C Endowment Fund CG0337 and bring it with you on the day.

Pay by Credit or Debit Card: can be arranged. (Please note your details will be stored in our database but not passed on to any other parties).

If you have any queries in respect of your course fee, please telephone 0141 314 0206. Thank you.

This session will build on knowledge gained at GCP training.  This is an introduction to the requirements of running a clinical trial of an investigational medicinal product.

This is suitable for members of the NIHR Associate PI Scheme, or people new to the PI role.

A full day CTIMP workshop is also offered to further knowledge and skills in this area.

This short session will build on knowledge gained at GCP training. It will highlight Principal Investigator (PI) responsibilities with regards to monitoring and audit to ensure good quality data and patient safety. This is suitable for members of the NIHR Associate PI Scheme, or people new to the PI role.

This short session will build on knowledge gained at GCP training. It will highlight the requirements of study set up, including preparation of site files, site initiation visits and recruitment strategies. This is suitable for members of the NIHR Associate Principal Investigator (API) Scheme, and those new to the PI role.

This short session will build on knowledge gained at GCP training.  It will highlight Principal Investigator oversight in research studies and discuss how this should be demonstrated throughout the study.

This is suitable for members of the NIHR Associate PI Scheme, and those new to the PI role.

We also offer the PI Roles and Responsibilities course to further develop skills and knowledge in this area.

This short session will highlight the different support departments in R&I and discuss the roles and responsibilities of each team.

Greater Glasgow and Clyde examples are shared but this could be extrapolated to most Health Boards.

This short session will discuss different types of trial design and consider practical examples.  It will highlight risk adaptive approaches to maintain patient safety and data integrity. This is suitable for members of the NIHR Associate PI Scheme, or people new to the PI role.

The aim of this workshop is to equip clinical research staff with an understanding of the key elements involved in conducting a clinical trial of an investigational medicinal product (CTIMP). The course builds on GCP knowledge and assumes GCP training has been completed prior to attendance.

The workshop will consist of a mixture of presentations, case studies and practical exercises.  It is relevant to those who are new to research and for those who would like to improve their understanding of clinical trials involving an investigational medicinal product

• Understand relevant CTIMP terminology and the requirements for CTIMPs including permissions and approvals 
• Demonstrate the use of a protocol in setting up a CTIMP and planning a study visit
• Describe the key issues that impact on recruitment and retention
• Describe the key elements relating to the management of the investigational medicinal product (IMP) 
• Recognise the importance of accurate documentation throughout all trial-related activities
• Understand the importance of safety measures and parameters in CTIMPs and the responsibilities of the research team in monitoring these

The aim of this workshop is to equip clinical research staff with an understanding of the key elements involved in conducting an early phase clinical trial of an investigational medicinal product (CTIMP). The workshop will consist of a mixture of presentations, case studies and practical exercises.  It is relevant to those who those who would like to improve their understanding of early phase clinical trials.

• be familiar with the phases of clinical trials
• have an understanding of pharmacokinetics and pharmacodynamics and the practical implications of obtaining these measurements accurately
• understand risk assessment in early phase trials and procedures to mitigate risk
• understand of safety reporting in clinical trials.

Good Research Practice (Non-drug Trials) This half-day course is appropriate for anyone conducting or supporting clinical research that does not involve a ‘drug’. The course will provide research staff with the knowledge to undertake quality research in accordance with the UK Policy Framework for Health and Social Care Research, recognising the responsibilities and requirements to conduct safe high-quality clinical research.

Topics include:

• History of Research Governance
• Informed Consent
• Roles & Responsibilities
• Documentation
• Data Management.

Pay by Cheque: please make out a cheque, payable to NHS GG& C Endowment Fund CG0337 and bring it with you on the day.

If you have any queries in respect of your course fee, please telephone 0141 201 9324. Thank you.

Informed consent is the foundation of all clinical research.  This workshop will focus on the legal and practical issues around obtaining informed consent from adults participating in clinical research, including vulnerable groups who require additional safeguards.  It will also cover consent issues relating to the use of human tissue and data in research.  The workshop will consist of a mixture of short presentations and activities.  It is designed for anyone who is involved in the informed consent process in clinical research. 

This is a three day induction course aimed at providing knowledge and practical skills to new clinical staff to clinical research.

Day one includes an overview of what clinical research is and the roles and responsibilities of the research team. Further sessions include a beginners guide to EDGE, how to read a protocol and an introduction to approvals and quality assurance.

Continuing on from our introductions to clinical research, this course will look at data collection, protection and confidentiality as well as safety in clinical trial.  A session on site file maintenance includes how to set up a site file and where to file essential documents.

The sessions in this course include how to process an amendment, monitoring, a more in depth overview of quality assurance.  Leadership and team working is vital in a clinical research team and with a session looking at team work this will assist with the skills required to manage a clinical trial, consolidating the knowledge from all three induction days.

This workshop follows the UKCRF Network guidelines for Laboratory skills training. The aim of the workshop is to equip staff with the knowledge and practical skills necessary to carry out sample handling and processing with particular emphasis on samples for research studies. The workshop is relevant to those who are new to research or to sample processing. After the workshop each participant will:

• Demonstrate knowledge of laboratory legislation, regulation and risk assessment
• Describe the safety precautions to be observed in a laboratory setting
• Explain the term pre-analytics
• Operate a centrifuge safely
• Demonstrate safe handling, processing and storage of samples
• Understand the regulations surrounding the transport and packaging of dangerous goods

The UK Policy Framework for Health and Social Care Research requires that all clinical research is conducted in accordance with the general principles of Good Research Practice. Those conducting research involving medical devices need to be aware of the set of research standards and legislation and understand their implications for practice.

After the workshop each participant will:

• Understand the range of products that fall under the definition of medical device
• Be familiar with the regulation of medical devices in the UK by the MHRA
• Understand the implications of the UK policy Framework for Health and Social Care Research

This course will be run jointly by Glasgow Clinical Research Facility and Edinburgh Clinical Research Facility. 

This online workshop will focus on the ethical, legal and practical issues around obtaining informed consent for paediatric clinical research in Scotland. The first half of the course examines the legislation and guidance in relation to consent, with a specific focus on who is able to give consent, dependent on the type of trial and the age of the participant. The second section discusses how to implement the legislation by closely examining the consent process and highlighting practical considerations.

Suitable for all those involved in paediatric trials, the aim of the course is to provide participants with an improved knowledge of the subject and the confidence to apply best practice within their own work areas.

Please note: this course focuses on Scottish legislation.

The aim of this workshop is to provide the key features for good poster design and basic rules for giving a presentation/talk. The workshop will consist of a mixture of short interactive lectures, practical sessions and discussion. It is relevant to those who will be presenting research work in the form of a poster at a conference, for individuals, from any discipline who have no previous lecturing experience, and for those who wish to improve their skills.

After the workshop, each participant will:

• understand the purpose of a conference poster
• be familiar with the basic rules for poster design
• understand the importance of words, images, colour and flow
• know how to design a presentation/talk
• recognise the importance of content and layout using PowerPoint
• understand the key points when delivering a presentation/talk

This three-hour interactive workshop will consist of an introduction to the principles of evidence-based practice and the process of critically evaluating a journal article, followed by practical experience in critically appraising a randomised controlled trial and systematic review.

The course will cover the following objectives:

• Understand the principles of evidence-based practice and the place of critically appraising the literature as one of its three pillars (professional experience, best available evidence, patient values and preferences)
• Recognise different research methodologies and know the relevant questions to ask of them in order to assess validity, importance and applicability
• Be aware of the tools and checklists available to assist you in reading critically
• Discuss the strengths and weaknesses of a study.

Note: This course is not being taught by a statistician and will not discuss the interpretation of statistics in detail.

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