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Clinical Trial Development Services

As a specialist UK CRO, PHARMExcel supports sponsors at the point where scientific ambition meets operational reality. Clinical trial development sets the direction for an entire programme, shaping protocol design, regulatory strategy, site selection, study start-up, monitoring and long term delivery. Getting these foundations right early reduces avoidable amendments, delays and downstream cost.

We work with biotech companies, charities, medtech developers and academic sponsors to translate early clinical concepts into credible, executable trial plans. Our teams bring practical insight from delivering studies across NHS and academic settings, helping sponsors sense check assumptions and build protocols that stand up in real clinical environments.

Clinical trial development explained

Clinical trial development covers the planning and design activities that take place before a study opens to recruitment. This includes defining objectives and endpoints, selecting the appropriate trial phase, shaping eligibility criteria, planning safety oversight and mapping the regulatory and governance pathway.

Development decisions influence how patients experience a study, how sites deliver assessments and how regulators interpret the resulting data. Early phase trials often focus on safety, tolerability and dose exploration, while later phase studies bring additional considerations around statistical power, consistency across sites and long term follow up. Each stage requires a different balance between scientific rigour and operational feasibility.

In the UK, trial development also involves navigating NHS capacity, research governance, ethics review and MHRA requirements. Understanding how these processes interact is central to building timelines and budgets that hold.

Why trial development matters

Protocols that look robust on paper can quickly unravel once sites begin set up or recruitment starts. Overly narrow eligibility criteria, unrealistic visit schedules or assessments that sit outside routine care place strain on investigators and patients alike. These pressures often surface as slow recruitment, protocol deviations or amendments that could have been avoided.

Early engagement with experienced clinical development teams allows risks to be identified before they become embedded. This includes testing recruitment assumptions, reviewing endpoint feasibility, understanding competing studies and aligning assessments with standard clinical pathways. For sponsors moving into the UK for the first time, these conversations are particularly valuable in bridging global development plans with local delivery realities.

Our experience in clinical trial development

PHARMExcel has supported clinical trial development across a wide range of therapeutic areas and study types and phases, with particular strength in early phase and complex investigator led research. Our teams work closely with sponsors and investigators to refine protocols, develop realistic delivery strategies and prepare for regulatory and ethics submissions.

Because we remain actively involved in study delivery, our development input is grounded in what sites can realistically deliver. We understand the pressures facing NHS departments, the impact of clinic capacity and the importance of aligning research activity with patient care. This perspective helps sponsors avoid designs that place unnecessary burden on sites or participants.

For each programme, we review the full development picture rather than isolated elements. That includes objectives, endpoints, safety considerations, data collection requirements and site feasibility.. The outcome is a trial plan that is scientifically sound and operationally credible.

"I have worked with other clinical trial research organisations on many studies and PHARMExcel has been by far the most effective in achieving targets and the easiest to work with on a day to day basis. I have no hesitation in recommending them as a CRO."

Dr Kim Orchard | Senior Lecturer and Consultant Haematologist, University Hospital Southampton NHS FT | Southampton

Our approach

We approach trial development as a collaborative process rather than a one off deliverable. Sponsors work directly with senior members of our team, allowing for open discussion, challenge and refinement as plans evolve. This hands on approach supports faster decision making and clearer alignment across stakeholders.

Quality and compliance underpin all development activity. Our work aligns with GCP and UK regulatory expectations, applied in a proportionate way that reflects the risk profile of each study. We support sponsors with MHRA and ethics strategy, documentation preparation and realistic planning around approvals and site activation.

Commercial transparency is central to our approach. We provide clear, itemised costings and help sponsors decide where external support adds most value versus activities retained in house. Our clinical trial development services can stand alone or feed directly into full service trial management and monitoring support.

Ready to discuss your clinical development programme?

If you are preparing for a proof of concept trial, shaping a first-in-human study, looking to get your study back on track and successful (rescue study) or revisiting a protocol that needs refinement, PHARMExcel can provide practical, independent input. We help sponsors move forward with confidence, grounded in an understanding of how trials operate in practice.

To discuss how our clinical trial development services could support your programme, contact our team to arrange an initial conversation.

FAQs

What does clinical trial development involve?

Clinical trial development covers the planning and design work required before a study starts. This includes defining objectives and endpoints, design, developing the protocol, planning safety oversight, assessing site feasibility, identifying suitable sites and preparing for regulatory and ethics submissions. Strong development work reduces the likelihood of amendments and delivery challenges later in the study.

Which trial phases can PHARMExcel support with?

We support development activity across the full clinical life cycle, with particular experience in early phase studies where safety, dose escalation and close oversight are central. Our teams also contribute to later phase trial development, including multi centre UK studies that require careful coordination across sites and consistent assessment approaches.

How does UK clinical trial development differ from other regions?

Developing trials for delivery in the UK involves specific regulatory, governance and operational considerations. These include MHRA and ethics review processes, NHS capacity, site contracting frameworks and integration with routine clinical care. Our familiarity with UK research environments and networks allows us to anticipate challenges and plan accordingly.

Can PHARMExcel support sponsors new to the UK?

Yes. We regularly work with overseas sponsors who are unfamiliar with UK specific clinical research systems. We provide clear guidance on feasibility, timelines and site selection, helping sponsors align global development strategies with UK requirements and expectations.

How does clinical trial development link with trial management and monitoring?

Effective development creates the framework that trial management and monitoring teams work within. Because PHARMExcel supports at all stages of trial delivery, our development input reflects downstream realities around site set up, monitoring intensity, safety reporting and data quality. This continuity helps ensure plans remain workable as the study progresses.

Can PHARMExcel support trial delivery outside of the UK?

Yes, the PHARMExcel team works with trusted partners and local experts to deliver trials outside of the UK, supporting sponsors global research programmes in other regions including the UK, Europe, Asia and the USA.