Trials Pharmacy

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.