A successful clinical trial does not begin when the first participant is enrolled. It begins much earlier, with the work needed to determine whether the study is deliverable, which sites are right for it and what needs to happen before recruitment can begin. Strong feasibility and well-managed study set-up create the foundation for efficient trial delivery, helping sponsors reduce avoidable delays and make better decisions before the study becomes active.
PHARMExcel provides specialist Study Start-Up and Feasibility services to support sponsors through the planning and activation stages of clinical trials. We work with biotechs, medtech companies, charities and NHS or academic sponsors, as well as US and EU-based organisations, to assess trial viability, identify suitable sites and move studies towards activation in a structured and compliant way. Our role is grounded in practical delivery, combining operational experience, regulatory understanding and strong site intelligence to help sponsors set studies up on realistic foundations.
Clinical trial feasibility assessment
Feasibility is one of the most important stages in study planning because it determines whether a proposed trial can be delivered successfully within the intended timeline, setting and patient population. A strong feasibility process helps answer practical questions early, before sponsors commit time and resource to sites or countries that may not be the best fit.
At PHARMExcel, feasibility includes assessing the intended patient population, the likely effect of inclusion and exclusion criteria, competing studies and the recruitment realities within the centres being considered. It also means looking closely at whether sites have the capacity, experience and operational readiness to run the study effectively. A centre may look attractive on paper, but if it is over capacity or has a slower internal set-up process, that can affect timelines significantly. This is where feasibility becomes more than a generic assessment exercise. It becomes a practical way of helping sponsors understand what is likely to work in reality.
Site intelligence, identification and qualification
Selecting the right sites is one of the most important decisions in study set-up. Even a well-designed protocol can lose momentum quickly if the sites chosen do not have the right patient access, infrastructure, staffing or experience to deliver the study as planned.
PHARMExcel approaches site selection with a strong emphasis on site intelligence. Through years of experience working with sites across therapeutic areas, particularly in the UK and Europe, we have built up a detailed understanding of how centres perform in practice. That means we can help sponsors look beyond reputation alone and think more realistically about capacity, competing studies, speed of set-up and likely delivery performance. Where a sponsor already has preferred sites in mind, we can still bring that intelligence into the discussion, helping them understand where delays may arise and how to work in the smartest way with those centres.
Regulatory and ethics approvals during study set-up
Once feasibility decisions have been made, the study set-up phase moves into the approvals and preparations needed to activate sites. PHARMExcel supports sponsors with the regulatory and ethics activities required to start a clinical trial, including Clinical Trial Applications, ethics committee submissions, local authorisations and related trial-specific documentation.
Our teams help ensure that submission packages are complete, clear and aligned with the needs of the study and the requirements of the relevant authorities. This includes supporting trial-related submissions in the UK, Europe, the US and other regions where required. The aim is not simply to submit documents, but to keep the study moving efficiently towards activation by reducing avoidable delays and managing the approval process in a structured way.
Study set-up, activation and operational readiness
PHARMExcel sees study set-up as the phase that takes a protocol from planning into operational readiness. In practical terms, that means the work needed to move from concept to the point at which a centre is approved and ready to recruit. Site contracts, approvals, training and study-specific preparation all need to come together before activation can happen.
Our teams support site initiation and activation by helping ensure that investigators and site staff are ready to conduct the study in line with the approved protocol and Good Clinical Practice requirements. This includes oversight of protocol training, safety reporting pathways, study-specific procedures and the wider practical arrangements that need to be in place before the first participant can enter the trial. Site activation is a major milestone, and getting to that point efficiently depends on good planning from the start.
Continuity between feasibility and delivery
One of PHARMExcel’s strengths is the continuity we bring across this stage of the trial. In some larger CROs, feasibility and set-up can be handled by separate teams and then handed over to delivery teams once the study goes live. That can create gaps, repetition and loss of context. At PHARMExcel, feasibility and set-up are driven by the same project and study management functions that remain closely involved as the trial progresses.
That continuity helps keep the study grounded in the assumptions made at the beginning. It also means that what is learned during feasibility is carried forward into delivery rather than lost in handover. For sponsors, that often leads to clearer communication, better operational control and a more joined-up approach from the outset of the study.
Why sponsors choose PHARMExcel for study start-up and feasibility
Sponsors choose PHARMExcel because we combine practical delivery knowledge, regulatory understanding and strong site intelligence with a more responsive and personalised way of working. As a smaller, specialist CRO based in the UK, we offer direct access to experienced senior staff, continuity of team and the flexibility that larger organisations often struggle to provide.
Our UK base gives us particular strength in UK site intelligence and NHS or academic research environments, but our work is not limited to UK-based sponsors. We support organisations across the UK, Europe and the US who need a realistic view of how studies can be set up and activated efficiently. Our aim is to help sponsors move from protocol concept to active trial with stronger planning, better site choices and greater confidence in the path ahead.
Ready to accelerate your study start-up?
From protocol feasibility and site selection to regulatory submissions and site activation, PHARMExcel helps you lay the foundations for a successful clinical trial. Speak to our team to discuss your study and discover how our experienced start-up specialists can help you achieve faster, more efficient trial delivery.