Trials Pharmacy

From EDGE user to EDGE team: Jen Peach

Jen Peach, Knowledge Team Manager,

I have more than 10 years of experience working in clinical trials within an NHS acute trust. Before joining the EDGE team in 2017, I worked across several areas of clinical research, including Clinical Trials Pharmacy, Cancer Research and Research and Development (R&D).

Having used EDGE myself throughout my time in the NHS, I understand first-hand the challenges faced by clinical research teams and the importance of having the right tools to support their work.

My career in clinical research

I spent approximately seven years working in Clinical Trials Pharmacy, taking on a variety of roles, including Senior Assistant Technical Officer, QA Lead and Team Manager.

My responsibilities covered a wide range of clinical trial activities, from managing Investigational Medicinal Products (IMPs) and maintaining pharmacy trial files to overseeing accountability records, temperature monitoring and the ordering and destruction of trial medication.

I also worked closely with sponsors, Contract Research Organisations (CROs), R&D teams, Principal Investigators (PIs) and Chief Investigators (CIs). This included reviewing the pharmacy sections of Clinical Trials Agreements, supporting trial finances, responding to data queries and attending site initiation and monitoring visits, both in person and remotely.

This experience gave me a thorough understanding of the operational and administrative demands involved in delivering clinical trials, as well as the importance of accurate records, effective communication and well-managed processes.

I then spent six months working as a Clinical Trials Assistant with cancer research nurses for the Central South Coast Cancer Research Network. In this role, I supported patient recruitment and visits, completed paper and electronic Case Report Forms (CRFs and eCRFs), maintained study site files and source data, and responded to sponsor and CRO queries.

My next move took me into R&D, where I spent approximately three years working as a Clinical Trials Facilitator. Here, I supported CIs, PIs and students throughout the research lifecycle, from the initial concept through to study closure.

I organised feasibility meetings involving sponsors, investigators, research nurses, clinical trials assistants and support departments. I also reviewed Clinical Trials Agreements, worked with sponsors and CROs, and collaborated with support departments to ensure study costs were accurate and accounted for.

This work took place during the early development of the costing processes that would eventually evolve into what is now the Interactive Costing Tool (ICT) developed by colleague Stevie Barre and EDGE Community Champion Mat Davis.

Joining the EDGE team

My connection with EDGE began while I was working in the NHS.

When I first joined the trust, we were using the original version of EDGE, with separate instances for cancer and non-cancer research. I later moved onto EDGE 2 when it launched, continuing to use the system until I left the trust in 2017 to join the EDGE team.

During my time in the NHS, I moved between departments, giving me experience of how different research teams used EDGE to support their work.

Since joining the EDGE team, I have seen the system develop considerably. What began as a tool I used in my own day-to-day role has evolved into a much more comprehensive system that supports research teams with managing their trial portfolios, participants and finances.

Having experienced this development both as a user and as a member of the EDGE team, I have a unique perspective on how the system has grown to meet the changing needs of clinical research.

Understanding the challenges users face

Working in the NHS research environment gave me first-hand experience of the pressures that clinical research professionals manage every day.

From staff and time constraints to funding pressures, tight deadlines and increasing demands from sponsors, I understand that research teams have to balance a wide range of responsibilities while ensuring studies are delivered effectively and in line with requirements.

I know that the systems they use need to support their work, make processes more manageable and help them use their time effectively.

Having worked across pharmacy, cancer research and R&D, I also recognise that different teams have different priorities and requirements. Understanding these perspectives is essential when developing and improving a system designed to support the wider research community.

We understand the users, because we used to be them

For me, having experience of working within the NHS is an important part of what I bring to the EDGE team.

Having been an EDGE user myself, I understand the practical realities of working in clinical research and the difference that the right tools can make to busy teams.

My experience helps me appreciate not only what users need from the system, but also the challenges they face in their roles and the pressures under which they work.

As EDGE continues to develop, I believe this understanding remains invaluable. By drawing on our own experiences as former NHS research professionals, we can continue to improve the system with the needs of its users in mind.

After all, we understand the users because we used to be them.

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.