From EDGE user to EDGE team: Roberto Aguiar

Roberto Aguiar, EDGE Technical Business Support Manager,

Before joining EDGE, I worked for 2 years as a Clinical Trials Administrator within the Trials Pharmacy at University Hospitals Southampton NHS Foundation Trust.

It was a varied role that gave me valuable experience across a wide range of research activities and processes, providing insight into the work that goes on behind the scenes to support clinical trials.

A key part of my role was managing the day-to-day operations of the studies assigned to me, working closely with pharmacy technicians and pharmacists to ensure that research activities ran smoothly. This included managing Investigational Medicinal Products (IMPs), from ordering and processing deliveries to responding to queries relating to stock levels, patient accountability and temperature excursions. Maintaining accurate records and ensuring that IMPs were managed appropriately was an important part of supporting patient safety and compliance with study requirements.

My responsibilities also extended to the set-up and ongoing management of clinical trials. I supported the creation of pharmacy folders, updated systems with study data and helped ensure that the necessary documentation and processes were in place before a study began. I also scheduled monitoring visits with study sponsors and Contract Research Organisations (CROs), following up on any queries raised during these visits.

Whilst working in Clinical Trials Pharmacy, I was responsible for finance related tasks such as preparing pharmacy invoice pro formas and helping with financial queries relating to invoices sent to sponsors and CROs. My job was also very clinical-based. I coordinated participant treatments between the Oncology pharmacy and research nurses. This involved ensuring that IV medication was delivered at the scheduled time, helping to support the smooth running of treatment schedules and the wider patient journey. I was also responsible for organising IMP deliveries to research nurses or directly to patients' homes, where required. These activities relied on careful coordination and communication between multiple teams to ensure that medication reached the right place at the right time.

My responsibilities continued through to the end of a study, where I managed the close-down process. This involved checking that all documentation had been signed off, working with sponsors to resolve outstanding queries, reviewing finances and ensuring that all applicable costs had been invoiced.

During my time within this role, I was of course introduced to EDGE. In particular I used it for tracking the setup of studies and other processes and datapoints of a studies lifecycle. EDGE was the tool used for tracking and recording of the pharmacy costs and we also used it a lot of the time to confirm the participant details when dispensing clinical trial medication as well as when dealing with the IMP returns.

Working as a Clinical Trials Administrator gave me a broad understanding of the processes involved in delivering clinical research within an NHS pharmacy and helped me take my next step in 2019. This is when I joined EDGE as a Knowledge Officer where I managed  client accounts, created new functionality requests based on user feedback and was responsible for the CPMS integration. Then in around 2023 I moved to the Product Team where I started my current role as Technical Business Support Manager. Now I oversee the product backlog (tickets used to create new functions to the system), support EDGE integrations with other systems, support the data implementation of new organisations and maintain the responsibility for the CPMS integration.

I feel my past experience working in research has given me first-hand knowledge of research processes, the challenges faced by NHS teams and the importance of developing solutions like EDGE that support the people using them every day.

New ‘Saved Searches’ Functionality Now Live on EDGE

Arpana Basu, Technical Business Support Manager

We are pleased to announce the launch of ‘My Saved Searches’.

A new functionality within Project Search on EDGE, designed to help users stay informed about new studies that may be relevant to them.

Making it easier to find relevant studies

The requirement for Saved Searches was identified by our Product Manager, Nicky Morris, as part of the Expression of Interest (EOI) work. One of the first steps in making it easier to record an EOI is to increase engagement with EDGE and make it easier for users to find studies of a particular type.

The new feature allows users to save their search criteria and receive notifications when new studies matching those criteria are added to EDGE. This provides a simple and effective way to keep track of emerging opportunities without having to repeatedly carry out the same searches.

We hope this functionality will support users throughout the project engagement process, particularly when discovering projects that may be relevant for assessing feasibility and expressing interest. By helping users identify relevant studies more efficiently, Saved Searches can make it easier to stay informed and engage with projects at the right time.

Stay informed with notifications

Saved Searches can be used to receive both internal EDGE notifications and email notifications. Users who wish to receive either type of notification should ensure that their personal notification settings are configured accordingly. These settings work in the same way as other EDGE notifications.

Users can also create and save as many searches as they need, allowing them to monitor different project criteria and areas of interest simultaneously.

Supporting users behind the scenes

The Knowledge team has also played a role in bringing this functionality to users. As part of the work, I was involved in testing the new functionality and then creating the Knowledgebase articles and support text to provide guidance for users.

This ensures that users have clear information available to help them understand and make the most of Saved Searches as part of their everyday use of EDGE.

With the introduction of ‘My Saved Searches’, EDGE provides users with a useful tool for keeping up to date with new studies and identifying projects that could be relevant to their organisation or future engagement.

We look forward to seeing users make the most of this new functionality as part of their ongoing use of EDGE.

Feel inspired: UHS host dedicated EDGE day to strengthen research management

Mikayala King, Research Governance and QA Manager, UHS

Showcasing University Hospitals Southampton NHS Trust for outstanding efforts in strengthening their use of EDGE

For more than 20 years, University Hospitals Southampton NHS Foundation Trust (UHS) has relied on EDGE to support the management of its research portfolio. Today, the system is firmly embedded within the organisation’s research and development processes, providing a central source of information throughout the research lifecycle.

With the introduction of new Key Performance Indicators (KPIs) from the Department of Health and Social Care, designed to measure research set-up times and delivery of research, the UHS R&D team recognised an opportunity to review how they could make the most effective use of all tools available to them.

To explore this, the team held a dedicated focus event around EDGE bringing together staff from across the R&D infrastructure.

Making the most of EDGE

Mikayala King, Research Governance and QA Manager at UHS, explained the thinking behind the event:

“We wanted to ensure that we were using all of the tools available to us to help manage expectations, to be able to react swiftly to changing situations with studies, and to look for trends to enable us to be more efficient.”

For UHS, EDGE is central to achieving this. As Mikayala explains:

“The main tool at our fingertips is EDGE. It is our source of truth and our contemporaneous record of everything that occurs prior to study set-up, including the EOI process, feasibility, and whilst the study is running, amendments and invoicing for activity.”

With EDGE playing such an important role, the team identified the need to ensure that everyone was confident in using the system and understood how information was captured, stored, retrieved, and subsequently reported.

A day focused on data, processes and collaboration

The full-day event provided an opportunity for different staff groups across the R&D department to refresh their knowledge of EDGE and explore how the system is being used across UHS.

Key areas covered during the day included:

• How UHS uses EDGE throughout the research lifecycle.

• The importance of data integrity.

• The value of timely and complete data entry.

• Where information is stored within EDGE and how it can be retrieved.

• How EDGE data is used and reported across the wider R&D department.

• Opportunities to improve workflows and make better use of existing functionality.

• Ideas for additional functionality that could provide greater insight into studies and support more efficient working.

The event was not simply about refreshing existing knowledge. It also created a forum for staff to share their experiences, identify challenges, and suggest ways that EDGE could be used more effectively.

Turning discussion into action

The event has already led to tangible improvements within UHS.

Following the discussions, changes have been made to forms and workflows, while data input has improved. The team is also planning a further event focused specifically on finance, recognising the importance of ensuring that financial information is managed as effectively as other areas of the research portfolio.

The team also identified areas where improvements and clarification would be valuable at a wider level. This includes suggestions to the NIHR around the handling and reporting of sub-studies and platform trials, as well as questions about where the data used to populate EDGE from CPMS is sourced.

Learning through practical activities

To reinforce the importance of good data management, the team took an engaging and creative approach during the day.

The importance of timely data entry was demonstrated using Rubik’s Cubes, while data integrity was explored through doctored jigsaw puzzles. The team also used doctored origami instructions to highlight the importance of clear and accurate instructions.

These practical exercises helped turn what can sometimes feel like abstract concepts into memorable, hands-on examples of how small errors, delays, or inconsistencies can affect the bigger picture.

Looking ahead: The next 20 years

For UHS, the focus event demonstrated the value of stepping back from day-to-day processes to review how systems, data, and people work together.

The team plans to continue pushing EDGE as far as possible, while working collaboratively with the EDGE team to explore opportunities for further development and improvement.

UHS plans to ensure that EDGE continues to be the trusted source of truth for research studies and that it remains a fundamental part of research management for many years to come.

UHS attendees of the EDGE day

From EDGE user to EDGE team: Beth Mathis

CIRU & EDGE Marketing Manager, Beth Mathis

Prior to my current position at EDGE, I worked in a few different research-based roles where I was first introduced to EDGE and, in fact, became a user of the system myself.

My research journey began in 2012 when I joined University Hospitals Southampton NHS Foundation Trust as a Pharmacy Support Worker in Clinical Trials. My main tasks included dispensing clinical trial medication, setting up trial folders and receipting trial drugs. I soon progressed to Senior Pharmacy Support Worker and later to Clinical Trials Coordinator, where I worked on mostly Oncology studies.

It was during these roles that I was introduced to EDGE, and it quickly became a helpful tool in my day-to-day work. I used it to help identify trial patients when prescriptions came into the pharmacy. It was also useful for gathering additional information that a Pharmacist might need, particularly when working in the main Oncology pharmacy, where clinical trials was just a small part of the medication dispensed in the dispensary and produced in the clean rooms.

My roles within Pharmacy involved a lot of paperwork including the upkeep of drug accountability logs, staff logs, drug destruction logs, and delegation logs. One thing I clearly remember was the amount of effort it could take to get, in particular, a delegation log completed. I was often hunting down a nurse or Principal Investigator (PI) for their paper signature, or trying to track down the paper log that had been left in a tray somewhere waiting to be returned. This certainly gave me an insight into the challenges and hassle that come with maintaining paper documentation for clinical trials.

After nearly three years in Pharmacy, I moved up to the Trust’s R&D department. This meant a small pay rise, but also a significant increase in the number of steps I did each day, walking all the way up to E Level! My role as a Research Assistant was heavily administrative and meant I worked with EDGE much more regularly. My main responsibilities included adding studies to the system and transferring information from both electronic and paper documentation.

I stayed within R&D for just over six months before discovering a vacancy within the EDGE team, which was based at UHS. I applied, had an interview, and soon became a Knowledge Support Analyst for the EDGE team. In this role, I supported the Knowledge Officers with implementations and support queries, while also beginning to work on new functionality for EDGE.

I was assigned specifications for new patient SAE functionality and, yes, you guessed it, a new electronic delegation log! I worked alongside our dedicated development team and other Knowledge team members to help design and build these new features. It was a great opportunity to take my experience as an EDGE user and use it to help shape the system itself.

A couple of years later, I moved into a brand-new role in Marketing and Communications, progressing to my current role as CIRU Marketing Manager. Today, I contribute to the direction of marketing and communications for our department, build on our user communication strategy and develop a number of EDGE Community channels. These channels help our user base enhance their EDGE skills, share knowledge, and connect members together to find better ways of working.

I do believe that having both the user experience and the ‘on-the-ground’ experience of working in clinical trials has really helped me in my role at EDGE. It has given me a valuable perspective when it comes to system development and communicating with our community.

Most importantly, it has helped me think like a user and understand the importance of putting the user at the forefront of what we do.

The new ISO 9001 Certification

Professor James Batchelor, CIRU Director

Building trust through Quality and Information Security Certifications

Here at the Clinical Informatics Research Unit protecting patient information and delivering high-quality services are fundamental to maintaining stakeholder trust. These principles underpin everything we do for the EDGE Programme. That is why we are proud to announce that we are certified with two internationally recognised standards: ISO 27001 for Information Security Management Systems (ISMS), achieved in May 2025 and ISO 9001 for Quality Management Systems (QMS), obtained in September 2026.

Together, these standards provide robust frameworks for managing information security, protecting sensitive data, and ensuring the consistent delivery of high-quality services and continual improvement across our operations. They provide assurance to NHS organisations, research partners, and collaborators that our processes meet recognised international standards for both information security and quality management.

Achieving and maintaining ISO 27001 and ISO 9001 certification demonstrates our Unit's commitment to safeguarding confidential information, meeting stakeholder expectations, and operating to internationally recognised best-practice standards. Our director Professor James Batchelor had the following words to say about CIRU’s recent success:

“We are excited to announce our continued high-level compliance with ISO 9001 and ISO 27001, demonstrating our additional commitment to providing our clients and stakeholders with assurances of our information security and quality systems management.”

ISO 27001 helps to ensure that confidential and sensitive information is protected throughout its lifecycle. For NHS partners, this offers confidence that data is handled responsibly, with appropriate controls in place to safeguard patient and organisational information while supporting vital research and innovation.

Complementing this, ISO 9001 focuses on quality, consistency, and continuous improvement. It encourages organisations to adopt efficient, well-managed processes that deliver reliable outcomes and respond to the evolving needs of stakeholders. For us this means regularly reviewing and enhancing our ways of working to ensure we continue to provide high-quality support for research, service improvement, and collaboration across the health and care system.

Both certifications strengthen our governance framework and reinforce our commitment to excellence. They help us meet the expectations of NHS organisations and beyond by embedding quality and information security into every aspect of our work, from project delivery and data management to stakeholder engagement and operational performance.

Most importantly, our certifications have been independently assessed and recognised by BSI, providing external validation that CIRU continues to meet the rigorous requirements of both standards. The BSI certifications demonstrate our ongoing commitment to supporting our stakeholders with confidence, integrity, and best practice, enabling research and innovation that ultimately benefits patients and the wider health and care community.