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.

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.