Case study: working with a world-class research site – Liverpool CRF

The UK’s Clinical Research Facilities (CRFs) and the departments and expert staff they provide are fundamental in the delivery of high intensity experimental research. By providing a dedicated site for research to take place, patients are more likely to be offered, and in turn, to participate in important clinical trials.

The UK Clinical Research Facility (UKCRF) network supports 54 sites based within NHS trusts in the UK and Ireland, providing centres of excellence, facilitating research, and bringing together NHS, academic, and industry expertise. In 2023, it was awarded £2.4 million funding by the National Institute for Health and Care Research (NIHR) to support research studies for five years.

As a CRO specialising in early phase trials, PHARMExcel works closely with CRFs across a broad portfolio of studies including rare disease such as Behcet’s Syndrome, COVID-19, liver dialysis device, and oncology. Our CRO services range from site selection/feasibility, clinical monitoring, eTMF and CTMS support to study close – always with a focus on participant safety and data integrity. CRF staff also receive training from us, and both parties work together to ensure study compliance throughout.

Unique features of a clinical research facility

CRFs are built to be centres of excellence, hosting the latest technology, and allowing access to expert researchers, all with the shared goal of advancing medical understanding and changing the lives of patients with a wide range of conditions.

By providing an infrastructure for industry led studies, CRFs are responsible for bringing together both NHS and academic expertise with multidisciplinary teams working together efficiently to deliver complex study protocols. With their agile infrastructure and flexible space allowing for them to adapt to meet the diverse needs of the researchers, they provide a safe and quality assured environment.

How a state-of-the-art clinical research facility can support your study

NIHR Liverpool NHS CRF, based in Royal Liverpool University Hospital, is an excellent example of a purpose-built research facility conducting high quality research. It was opened in 2009 and was the first site to achieve the MHRA Phase 1 Accreditation. This means the site has exceeded the basic regulatory good clinical practice (GCP) standards by having additional procedures, including the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.

Liverpool CRF features excellent facilities, dedicated Principal Investigators with experience as clinical pharmacologists, a team of scientists, physicians, nurses and laboratory staff, and access to specialist hospital services. The CRF can host up to 12 patients overnight and can provide a database of both healthy volunteers and diverse patient populations. There is also a laboratory for sample processing, as well as co-located storage facilities with central temperature monitoring. These world-class features can facilitate complex study procedures. The site operates like a commercial organisation, unlike academic-funded sites supported by milestone payments which can slow down progress of the study. The site, like many CRFs, provides a strong scientific arm to the study. It values the additional industry expertise and resources a CRO brings to the table to deliver a quality-driven, timely research operation.

Left: Yvanne Enever, CEO of PHARMExcel, and Becky Lyon, Senior Research Nurse at NIHR Liverpool CRF. Right: Patient room at NIHR Liverpool CRF.

PHARMExcel case study:  AGILE CST-6 COVID study at Liverpool CRF

PHARMExcel was selected as the CRO to provide full study management for the AGILE CST-6 study, a Phase I/II platform study based at Liverpool CRF. This included regulatory, biostatistics and vendor oversight activities, leading Trial Management Groups (TMGs) and contributing as a voting member at the safety review committees. Agile-CST-6 set out to determine the Phase II dose and evaluate the safety and efficacy of IV Favipiravir for the treatment of COVID-19. The study recruited four cohorts and was the highest recruiting study across the Agile Platform, which included non-UK sites.

This study design included a 2:1 randomised open-label standard of care (SoC) controlled phase I of IV Favipiravir, followed by a 1:1 blinded, parallel group phase II trial of IV Favipiravir versus placebo (plus SoC).

The study is still currently recruiting adult in-patients (≥18 years) with laboratory confirmed COVID-19 infection by positive polymerase chain reaction (PCR) test.

What makes a good site-CRO relationship?

PHARMExcel is proud of the consistently positive feedback it receives from the sites it works with. It understands from the site perspective what is important in order not to burden the site but enable it to deliver on its targets.

Clear communication and flexibility

Creating a partnership based on clear communication and flexibility provides a positive base for the relationship throughout the study. This allows both sides to align their goals and understand each other’s strengths.

Relationships between sites and CROs also benefit from setting clear and realistic joint goals. This can be established during study set up, with well thought out protocols from the Sponsors and CROs, inviting site involvement early in the process to ensure their perspective is considered and the availability of their resources is taken into account.

An invested team

Talented and invested team members play a crucial role in clinical trial delivery, in particular the Clinical Research Associate (CRA) assigned to the study. It is important the CRA builds a positive relationship with the site. An enthusiastic, competent, and experienced CRA can provide significant support and manage site-related issues quickly. The CRA is the key liaison between the CRO and the site, having conversations with both sides and building trust.

Building relationships and utilising strong CRAs lead to positive trial outcomes

For a Sponsor, utilising the services of a CRO that has excellent relationships with CRFs brings added value to the trial set up process. Having worked with CRFs on previous studies, the CRO will have an understanding of a CRF’s capabilities and built up a working relationship based on trust. Additionally, the Sponsor saves time on researching the sites that fit their needs, as the CRO can reach out quickly to a trusted CRF that they have worked with before.

The Sponsor can take advantage of an already positive working relationship between the CRO and the CRF, with an expert CRA bridging the gap, benefiting from the joint expertise and collaborative history.

PHARMExcel works closely with CRFs when undertaking site feasibility on behalf of its sponsors, making sure that only the sites that meet the specific study requirements are approached.

The overall benefits of a world-class research site

Having world-class research sites like NIHR Liverpool CRF readily available to support clinical research benefits all aspects of the study, especially when the sites are brought into the process early in the planning stage of the study.

It also benefits the people at the centre of the research – the patient. The patient pathway should be the highest consideration when setting out the study, an outcome which can only be achieved if the study is designed around the patient journey. This can be achieve with a strong partnership between the site and a flexible, responsive CRO.

Combining access to a world-class research site with a CRO team of skilled CRAs and study/project managers, PHARMExcel is well placed to provide the necessary level of support required by site and sponsor to deliver successful trial outcomes.

PHARMExcel prioritises its relationship and connections with sites across the UK to build a network of established and expert locations for trials to take place in. This is immensely important for Sponsors who are looking for guidance in this area and who need the capabilities of world-class sites as they can access what they need through pre-existing relationships.

Overall, the benefits of working with world-class sites mean that all the study’s site needs are met. Partnering site success with a CRO such as PHARMExcel who has embedded positive relationships with those sites brings benefits to the Sponsor and is likely to improve both trial and patient outcomes.

About PHARMExcel

PHARMExcel is an award-winning, full-service Contract Research Organisation (CRO) providing a flexible and innovative approach to clinical trial delivery. The company is recognised for its in-depth knowledge and experience of the clinical research environment, particularly in the UK, and has a network of regulatory and industry associates, allowing it to provide a global reach.

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