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Clinical Trial Monitoring Services

PHARMExcel provides clinical trial monitoring that gives sponsors confidence in data quality, participant safety and regulatory compliance, without placing unnecessary burden on sites. Our monitors work closely with investigators, site teams and sponsors to maintain oversight that reflects the true risk profile of each study and the realities of delivery in NHS and academic settings.

We support monitoring across early and late phase studies, including Clinical Trials of Investigational Medicinal Products (CTIMPs), device and diagnostic trials, and non-interventional research. Our approach combines on-site, remote and central monitoring, aligned to International Council for Harmonisation (ICH GCP) and UK guidance, and shaped around your protocol rather than a fixed template.

Clinical trial monitoring explained

Clinical trial monitoring is the structured oversight of trial conduct to confirm that participants are protected, data are credible and the study is delivered in line with the protocol, GCP and regulatory approvals. In practice, this involves regular review of informed consent, eligibility, safety reporting, investigational product handling, source data and essential documentation.

Modern monitoring has moved away from routine, high-frequency source data verification across every data point. Regulators and funders now expect monitoring strategies to be proportionate and risk-based, focusing effort on the processes and data that matter most to participant safety and trial integrity. Effective monitoring therefore depends on good judgement, strong communication with sites and a clear understanding of where things can realistically go wrong.

Why monitoring matters

Overly intensive monitoring can slow recruitment, frustrate site teams and divert attention from genuine risks. Too little oversight leaves sponsors exposed to protocol deviations, delayed safety reporting and data that cannot support reliable conclusions. The challenge lies in finding the right balance.

UK trials often run in busy NHS departments where research activity sits alongside routine care. Shared facilities, rotating staff and competing clinical pressures all influence how a protocol is delivered in practice. Monitoring plans that ignore these factors tend to generate repeated findings without improving study quality. Our role is to help sponsors focus monitoring effort where it delivers real value, supporting sites to get things right rather than simply documenting issues after the fact.

Our experience in clinical trial monitoring

PHARMExcel monitors have hands-on experience across a wide range of therapeutic areas and study designs, including first-in-human studies, dose escalation trials, multi-centre Phase II and III programmes, and investigator-led research funded by charities or public bodies. We are familiar with the governance frameworks that apply within the UK, including NHS R&D processes, sponsor oversight expectations and inspection readiness.

Because we work closely with UK investigators and research offices, we understand common pressure points such as consent timing, eligibility interpretation, safety reporting workflows and pharmacy capacity. This allows our monitors to identify emerging issues early and work constructively with sites and sponsors to resolve them before they escalate.

Our approach to monitoring

We develop a study-specific monitoring plan for each trial, informed by protocol complexity, participant risk, site experience and data criticality. This plan sets out the mix of on-site, remote and central monitoring activities, the frequency of visits or reviews, and clear escalation pathways for safety or compliance concerns.

Our monitors act as a consistent point of contact for sites, providing guidance on GCP expectations, documentation standards and protocol requirements. Monitoring findings are reported clearly and promptly, with a focus on practical corrective actions rather than volume of observations. Where appropriate, we work with sponsors to adapt the monitoring strategy as the study progresses and risks evolve.

Quality oversight is embedded within PHARMExcel through our ISO 9001 certified quality management system. Monitoring activities feed into sponsor oversight, risk review and audit preparedness, providing assurance that the trial remains under control throughout its lifecycle.

Working with PHARMExcel as your monitoring partner

Sponsors work with PHARMExcel when they want monitoring delivered by experienced professionals who understand both regulatory expectations and site realities. As a smaller UK CRO, we provide direct access to senior staff and continuity of the same monitoring team, enabling informed discussions and timely decision making.

We are comfortable integrating into sponsor oversight structures, working alongside internal teams or other service providers. Our monitoring services can be provided as part of a full service CRO package or as a standalone solution to strengthen oversight of an existing programme.

Commercially, we aim for transparency and flexibility. Monitoring budgets are clearly itemised, and our level of involvement can be scaled to match your internal capability and risk appetite.

"The support from PHARMExcel has been extremely high quality. This includes all aspects trial development, management and monitoring, that was also evidenced by a recent sponsor audit. We look forward to working with PHARMExcel going forwards."

Tom Fletcher | CST-6 Candidate Chief Investigator | Director Global Health Trials Unit, Liverpool School of Tropical Medicine

Your monitoring requirements

If you are planning a new clinical study or reviewing the effectiveness of monitoring on an ongoing trial, PHARMExcel can help you develop a proportionate, risk-based approach that supports sites and protects data quality. To discuss how our clinical trial monitoring services could support your programme, contact our team to arrange an initial conversation.

FAQs

What does a CRO monitor during a clinical trial?

A CRO monitor oversees trial conduct at participating sites to confirm that participants are consented appropriately, safety is reported correctly, and data are recorded accurately and in line with the protocol and GCP. This includes reviewing source data, trial documentation, investigational product management and site processes, as well as providing guidance and support to site staff.

What types of monitoring does PHARMExcel provide?

We provide on-site monitoring, remote monitoring and centralised data review, used in combination according to the needs of each study. Many trials benefit from a blended approach, with targeted site visits supported by ongoing remote oversight of key data and safety signals.

How is risk-based monitoring applied in practice?

Risk-based monitoring starts with identifying the aspects of a study that are most critical to participant safety and primary endpoints. Monitoring effort is then focused on those areas, with reduced intensity where risks are lower or controls are strong. This approach aligns with current regulatory guidance and supports efficient use of resources.

Can PHARMExcel take over monitoring for an ongoing trial?

Yes. We regularly support sponsors who need additional monitoring capacity or a change in approach part way through a study. After a structured handover and risk review, we can integrate into the trial and provide continuity of oversight.

How does PHARMExcel ensure monitoring quality and compliance?

Monitoring activities are delivered within our quality management system and in line with ICH GCP and UK regulatory requirements. Monitors receive ongoing training and oversight, and monitoring outputs feed into sponsor reporting, quality review and inspection readiness.