Unlocking Research Income with EDGE

Donna Foster – Clinical Trials Governance & Data Manager, Research and Development, The Princess Alexandra Hospital NHS Trust, UK

At The Princess Alexandra Hospital NHS Trust, research activity continues to grow across a broad range of specialties. The Trust currently supports around 75 active studies across three sites, including commercial and non-commercial trials, portfolio and non-portfolio studies, and academic research. Approximately 15% of these studies are commercial, a proportion expected to rise as the Trust expands its commercial research activity. Ensuring that study activity is accurately tracked and supported by robust financial processes is therefore essential, especially with research teams working across multiple departments and sites,

When Donna Foster joined the Research, Development and Innovation (RD&I) department in November 2023, she quickly identified that financial tracking within research studies was an area that needed attention. At the time, invoices were typically raised only when sponsors requested them, and there was no central system to record study activity or verify whether all billable work had been captured. “When I arrived, finance wasn’t prioritised,” Donna said. “Invoices were often only raised when sponsors asked for them, which meant there was no clear way of checking whether everything we had done had actually been claimed for.”

Although staff were aware that EDGE had finance capabilities, the tools had never been implemented due to uncertainty around how to configure them. Donna was determined to change this and contacted the EDGE team for support. Within days, the team held their first Teams call with Stevie and Mat to use the commercial and non-commercial import tools. They were up and running at the Trust within a week.

The impact was immediate. The first study Donna applied the system to was a commercial trial where the sponsor had requested a final invoice of £6,000. By retrospectively recording historical activity within EDGE, she was able to identify additional billable work that had not previously been captured. The final invoice issued exceeded £24,000 after reviewing the records with the sponsor. “My achievements regarding implementing the EDGE finance tools was recognised in the Trust’s proudest moments, and highlighted the money that would have been ultimately lost if these tools had not been introduced.”

Today, the RD&I department uses both the commercial and non-commercial finance import tools within EDGE to track study-related income. Research staff across the department – including research nurses, clinical trial practitioners, pharmacy teams, and data teams – record activities such as study visits, monitoring visits, participant travel expenses, and consumable checks directly in the system. While it initially took some time for clinical teams to adjust to recording financial activity alongside research tasks, the process has now become embedded in day-to-day workflows.

The results have been significant. Donna said: “Within the first three months of implementing the finance tools in EDGE, the department recovered more than £100,000 in previously unclaimed income from historic studies.” This ensured the department finished the financial year in a positive position and created a stronger financial foundation moving forward. During the 2024/25 financial year, the RD&I department recorded the highest research income in its history – a milestone supported by the ability to track study activity and associated income in real time.

Beyond recovering lost revenue, the system has also helped the team improve efficiency. Because research activity is now recorded at the time it occurs, invoices can be prepared quickly and with confidence that all eligible costs are included. Management and summary reporting tools within EDGE also provide insights into current and projected income, helping the department make informed decisions about future growth and team expansion.

Donna has since shared her experience with other organisations through EDGE events and professional networks, encouraging other Trusts to adopt the finance tools to strengthen their own cost recovery processes. As research activity continues to expand, the integration of financial tracking within EDGE is helping the Trust build a more sustainable and transparent research environment. “I cannot express enough what a difference the finance tools have made. I would recommend them to all Trusts.”

Smarter Delegation with EDGE

Dr Mikayala King – R&D Governance, QA and Sponsorship Manager, University Hospital Southampton NHS Foundation Trust, UK

At University Hospital Southampton (UHS), delegation of duties is a vital part of research delivery. It ensures that specific tasks are formally assigned by the Principal Investigator (PI) or Chief Investigator (CI) to appropriately trained members of the research team. While duties can be delegated, the PI or CI retains overall responsibility for the study. This makes accurate and up-to-date records essential.

Historically, this process was managed on paper. Delegation logs often ran to several pages of names, trial roles, duties, signatures, and dates. Updating them meant physically tracking down team members for signatures – a process that was both time-consuming and prone to inconsistencies or missing information. As Dr Mikayala King recalls, “Before EDGE, signing off a delegation log meant a lot of paperwork – and a lot of time.”

The solution came in the form of the EDGE Delegation Log, which was developed to replace cumbersome paper records with a clear, concise, and regulation-compliant electronic system. The tool allows authorised staff to update records remotely, store all key details in one place, and keep a complete audit history. Information such as staff names, roles, approvals, start and end dates, responsibilities, and signatures can be accessed and updated online with the added benefit of downloading reports in familiar formats like Excel.

UHS rolled out the EDGE Delegation Log across all sponsored studies. The implementation involved engaging nursing teams and PIs/CIs in discussions, running workshops, and even providing one-to-one support to update signatures directly. This practical, hands-on approach ensured that staff could start using the system quickly and confidently. The Delegation Log is now embedded into standard EDGE training for all new users.

“It’s easy to understand, adaptable to our needs, and keeps everything in one place,” says Dr King. “We’ve reduced both the time to sign-off and the number of incidents related to delegation logs, while making the whole process more efficient for our teams.” Looking ahead, UHS sees the Delegation Log as an important step toward building a fully integrated, paperless research environment, one that supports compliance, transparency, and smoother collaboration across the research community.

The impact has been significant. The time required to get delegation logs signed off has been reduced, incident reports related to delegation logs have dropped, and unnecessary printing has been cut back, which has supported the wider shift to digital records. The system has also improved cross-site collaboration, making it easier to share accurate, up-to-date information with partners such as the CDRC. Other sponsors are now beginning to adopt the EDGE Delegation Log at the feasibility stage, which has extended its benefits beyond UHS.

Equality, Diversity, and Inclusion (EDI) - New NHS project using EDGE

After going live on the 22nd of September this year, our team are thrilled to announce the next milestone in the Equality, Diversity, and Inclusion (EDI) in Health and Care Research Pilot has been achieved.

On the 5th of November the first extract of EDI pilot data was extracted from EDGE for participating organisations and sent to NHS England for review. Further extracts will be taken on a monthly basis for any organisation choosing to opt into the EDI pilot via EDGE.

The EDI project support understanding of inclusion, representation, and participation and identifying variation in participation in health and care research across the geography of England. In the long term it is intended that analysis of this data will directly improve equality, diversity, and inclusion in such research and ultimately improve access to good quality, evidence-based health and care.

NHS England will provide results of its analysis in the form of reports and dashboards, which will inform the Department of Health and Social Care’s (DHSC) strategy and policy decisions with the support of the National Institute for Health and Care Research (NIHR), aligned with the “Best Research for Best Health: The Next Chapter” and as set out in the NIHR Research Inclusion Strategy 2022-2027

It's not too late to include your organisation in the EDI pilot. Further details about how to opt in can be found on the links below.

Questions about the Equality, Diversity and Inclusion (EDI) in Health and Care Research pilot

CIRU's success in ISO 27001 Certification

CIRU’s success in ISO 27001

certification

We are thrilled to share that our department, The Clinical Informatics Research Unit have been successful in achieving certification to an international information security management system (ISMS) standard called Information Security Management System (ISO 27001). The standard provides a framework for organisations to manage their information security and protect their data. Achieving ISO 27001 builds trust with our clients and demonstrates the Unit’s commitment in securing confidential information. The certification has been recognised by BSI – information on this company found further below.

The certification was achieved in March 2025 following an in-depth audit process and 18 months of hard work from our small team here at CIRU. The lack of critical, major, or minor findings clearly demonstrates the quality and dedication of the department.

Following this great achievement we spoke to Professor James Batchelor, CIRU Director / Associate Dean International Research & Enterprise, Faculty of Medicine, who said the following:  

“The ISO 27001 certification is a testament to the dedication, meticulous planning, and collaboration of the CIRU team. From thorough risk assessments to implementing strong security controls and producing key documentation, the team has shown exceptional professionalism and commitment to excellence. I’m truly grateful for the team’s hard work in reaching this milestone. This achievement reflects our collective expertise and dedication to maintaining the highest standards of information security at CIRU.”

About CIRU:

CIRU has over 25 years of experience in providing clinical research solutions and services across the globe, advancing data excellence, quality, management, and improving research conduct. The University department of no more than 35 employees works with organisations across 7 continents including Europe, North America, South America, Australasia, Asia, and Africa. Achieving ISO 27001 strengthens CIRU’s reputation in both data security and patient safety, not only to their clients but to their partners, stakeholders, and to the public.

David Mudd, Global Head of Digital Trust Assurance at BSI, remarks:

“The global digital landscape means core research practices are increasingly cloud-based and digitally reliant, and it is essential for organizations like CIRU to remain vigilant against cyber threats, particularly in the realm of healthcare and clinical research. Achieving certification highlights CIRU’s commitment to safeguarding sensitive data, ensuring the integrity of clinical research, and adhering to global best practices in establishing digital trust. CIRU should be commended for its proactive approach to managing information security, supporting regulatory compliance, and strengthening resilience for the future of clinical informatics research.”

About BSI:

Since 1901, BSI has been creating an enduring legacy of transformation for the benefit of all. Across all divisions and services, BSI delivers on its purpose by helping its clients to fulfil theirs. For over a century, BSI has driven best practice in organizations around the world and support a 13,000-strong global community of experts. With our extensive expertise in standards, Assurance, Regulatory, and Consulting services, we can support you to enhance your performance, achieve sustainable growth, manage risks, and be a partner in progress.

For more information contact ciru@soton.ac.uk

Fergus Walsh to host our 25 Year Silver Jubilee celebration

Fergus Walsh to host our

25 Year Silver Jubilee celebration

Fergus Walsh, BBC Medical Editor

The BBC’s Medical Editor Fergus Walsh is set to return to the next EDGE Conference, taking place on the 4th and 5th June of this year at the Hilton London Heathrow T5. Fergus is returning as host to the EDGE Conference for the 4th time after proving to be a very popular choice amongst our community of users. 

Fergus will be hosting our Silver Jubilee event ‘TOGETHER 25’ which marks 25 years of EDGE and will celebrate 25 years of sharing, learning, and innovating amongst the EDGE user community. This very special event also aims to kickstart shaping the next 25 years of research excellence and will showcase EDGE expert users working within the field of research, who will share their best practice, knowledge, and practical ways in utilising EDGE and will demonstrate the strength of working together.  

Fergus will steer the direction of the keynote speakers, including impactful presentations from real-life patients sharing their ‘Real Research Stories’, as well as informative talks from across the healthcare and research industry.

About Fergus Walsh:

Fergus Walsh is the BBC's Medical Editor and one of its longest serving journalists. He has played a key role in covering the Covid pandemic which included reporting from intensive care units in several hospitals, as well as following the development and deployment of vaccines. Fergus is based at New Broadcasting House in London and appears mainly on the Six and Ten O’Clock TV News on BBC1. His reports are seen globally via BBC World News. Fergus also reports for Panorama, the world’s longest-running investigative TV programme. He can be heard on BBC radio, on the Today programme, BBC Radio 5 Live, and on the Newscast podcast. He also writes for the BBC news website. 

Fergus went to the Royal Grammar School in High Wycombe (1974-1980), Leeds University (BA Hons English Lit 1983), and Falmouth Technical College (post-graduate dip radio journalism 1984). He began reporting for the BBC in May 1984 and within weeks had his first voice piece on national radio. At the age of 26 Fergus became one of the BBC's youngest specialist correspondents, reporting for radio on Home and Legal Affairs. In 1990 he moved to television and worked briefly as political, diplomatic, and education correspondents before moving to health and science. He was appointed medical correspondent in 2004 and medical editor in 2020.  

Fergus has reported from more than two dozen countries on topics such as malaria, TB, HIV, obesity, genetics, antibiotic resistance, healthy ageing, and medical ethics. He has volunteered for several medical trials, including testing a vaccine against H5N1 avian flu. He has had his brain, heart, and other organs scanned for television reports. In 2009 he appeared as himself in an Emmy award-winning TV drama with Dame Julie Walters about assisted dying. 

To learn more about the EDGE Conference 2025, see here.

A Real Research Story at the EDGE Conference 2025

A Real Research Story

at the EDGE Conference 2025

Tanya and Nadim Ednan-Laperouse OBEs , The Natasha Allergy Research Foundation

As our 7th EDGE user conference is fast approaching, we are honored to share one of our keynote speaker sessions with you. We are feeling very privileged to have both Tanya and Nadim Ednan-Laperouse OBEs and founders of The Natasha Allergy Research Foundation presenting to our audience of EDGE users and research professionals. 

Nadim and Tanya set up The Natasha Allergy Research Foundation, the UK’s food allergy charity, in 2019 after their daughter Natasha died aged 15 from an allergic reaction to food. In addition to supporting bereaved families, the charity has three key pillars of work: education and awareness, campaigning and advocacy and clinical research. The £2.7 million Natasha Clinical Trial, the charity’s first major research project, uses every day, shop-bought foods rather than pharmaceuticals to try to desensitise children and young people with peanut and cow’s milk allergies. The charity hopes the trial results will lead to the NHS making this form of OIT (Oral immunotherapy) available as a treatment for people with food allergies.

Tanya and Nadim will be our first keynote speakers on day 1, opening the conference which is sure to be a very impactful talk, sharing their real research story. Their talk will be one of two real research stories taking place across the 2 days which gives the EDGE conference a different dynamic and meaning. The patient talks are a powerful reminder to our delegates how important their roles are in the field of research, no matter how big or small they may be.

More about the conference:

Our CPD-certified event TOGETHER 25 is taking place on the 4th-5th June this year at the Hilton London Heathrow Hotel and will celebrate 25 years of sharing, learning, and innovating amongst the EDGE community.  This special event marks our Silver Jubilee and is being hosted by none other than Fergus Walsh, BBC Medical Editor, as he returns for his 4th EDGE conference.  We are set to have impactful presentations from real-life patients as well as informative keynote speakers from the healthcare and research industry.

The event also aims to kickstart shaping the next 25 years of research excellence and will showcase EDGE expert users working within the field of research, who will share their best practice, knowledge, and practical ways in utilising the EDGE Programme to ultimately shape research excellence and efficiency. TOGETHER 25 is the opportunity to unite with fellow members of the EDGE community and will showcase the strength of working together.  

More information on our special Silver Jubilee event can be found here.