A partner to help get your study back on track
Clinical trials do not always progress according to plan. Enrolment may fall behind expectations, sites can underperform, data quality issues may emerge or weaknesses in project oversight can place timelines under pressure.
PHARMExcel supports sponsors managing delayed, underperforming or operationally challenging studies. We assess the issues affecting delivery, identify practical priorities and help strengthen trial oversight while protecting participant safety, data integrity and regulatory compliance. Support can range from targeted intervention in one area to broader operational recovery where several functions are affected. Our approach starts by understanding why performance has moved away from plan and what needs to change. We can intervene at any stage of the clinical trial from regulatory submission and site activation through to monitoring and close-out.
When might a clinical trial need rescue support?
PHARMExcel can review the study to understand the scale and likely causes of underperformance before helping determine an appropriate recovery approach.
Rescue support can be focused on a specific resource gap. You may need additional monitoring capacity or help completing outstanding close-out visits, rather than a wider change to study management.
Gap analysis and clinical trial rescue assessment
We start by listening to your concerns and establishing a clear picture of the study as it stands. Depending on your needs, we assess the operational, clinical, regulatory, safety and data-related factors affecting delivery. This may include timelines, site performance, enrolment progress, monitoring findings, safety information, data quality, the protocol and essential documentation
The aim is to identify underlying causes rather than focus only on visible symptoms. An apparent enrolment problem, for example, may actually reflect poor site selection, unrealistic feasibility assumptions or limited site capacity. This gives sponsors a clearer view of the issues requiring attention and the priorities for recovery.
We work collaboratively with the people closest to the study, including your team, site R&D teams, investigators and those responsible for data quality. These discussions help clarify outstanding issues, test assumptions and agree practical steps towards resolution.
Clinical trial rescue support tailored to your needs
We can take responsibility for the whole study or provide focused support where you need additional expertise or capacity. Our support includes:
Site feasibility and qualification – revisit site readiness, patient availability and recruitment expectations.
Site contracts and activation – support contract execution and address outstanding requirements affecting start-up.
Regulatory and ethics submissions – support submissions and updates required during a CRO transition.
Recruitment oversight – work with sites to understand barriers and agree practical actions to support site-led enrolment.
Clinical monitoring – provide additional monitoring capacity or take responsibility for agreed monitoring activities.
Project management – coordinate study activities, clarify responsibilities and maintain communication across stakeholders.
Site close-out – carry out outstanding visits when resource constraints are delaying completion.
Supporting studies during CRO or operational transition
Moving an active study to a new CRO requires careful coordination. A clear handover helps maintain study knowledge, documentation and site relationships, while ensuring outstanding activities have an agreed owner.
Where PHARMExcel joins an existing study, we focus on understanding current responsibilities, site status, essential documentation, safety obligations and operational risks. We can work with sponsors and existing providers to clarify ownership and maintain continuity across the study. The exact scope of any transition depends on the study, existing systems and responsibilities agreed with the sponsor.
We have experience of stepping in at critical stages of a study. Where required, we can support updates to regulatory records, amendments to site contracts and communication with sites about the change in CRO.
We can work within your existing Trial Master File (TMF) and electronic data capture (EDC) systems, or provide alternatives if needed. We agree the approach with you, taking account of the study’s requirements and existing ways of working.
Site performance and enrolment recovery
This may involve closer site oversight, additional training, reassessing poorly performing centres or identifying alternative sites with stronger patient access and operational capacity. Our site intelligence, particularly across the UK and Europe, can also help sponsors make more realistic decisions
Case study: Clarifying site feasibility and addressing start-up delays
A sponsor approached PHARMExcel after significant delays in study start-up and site contract execution. They lacked a clear view of progress and were receiving inconsistent information about expected patient numbers.
We contacted the relevant regulatory bodies to update the CRO details, supported contract amendments with existing sites and followed up with sites where contracts were still being negotiated. We also revisited feasibility across all sites, giving the sponsor a clearer picture of recruitment potential and outstanding requirements.
Data quality, monitoring and trial integrity
Unresolved operational issues can affect data quality. Missing information, outstanding queries, protocol deviations and inconsistent documentation can reduce confidence in study data and create additional work before database lock.
PHARMExcel can combine clinical monitoring, data management and project oversight to identify quality gaps. Depending on scope, this may include closer monitoring, review of outstanding data issues, query management and stronger oversight of recurring protocol or documentation problems. Where wider process weaknesses are identified, we can work with sponsors to establish practical corrective actions.
Case study: Additional monitoring capacity when it is needed
When a sponsor identified resource gaps affecting monitoring visits, PHARMExcel provided support specifically for those activities. This brought additional capacity into the study without requiring a full CRO transition.
Case study: Helping complete outstanding site close-out visits
We have also supported studies where a lack of resources was delaying site close-out. By providing capacity to carry out outstanding visits, we helped address the delays efficiently.
Corrective actions and stronger study governance
Rescue work should address the causes of underperformance, not only the immediate symptoms and, depending on the assessment, we may recommend changes to project governance, site oversight, monitoring, training, enrolment assumptions, vendor management or study processes.
Responsibilities and priorities can then be clearly defined so sponsors and study teams understand what needs to happen and how progress will be assessed. In instances where formal corrective and preventive action processes are required, PHARMExcel can support activities relevant to its agreed study responsibilities.
We agree responsibilities, priorities and how progress will be reviewed with you and the wider study team. Throughout, our focus is on straightforward communication, shared expertise and a collaborative approach to resolving issues.
Regulatory and safety oversight during trial recovery
Clinical trials do not always progress according to plan. Enrolment may fall behind expectations, sites can underperform, data quality issues may emerge or weaknesses in project oversight can place timelines under pressure.
PHARMExcel supports sponsors managing delayed, underperforming or operationally challenging studies. We assess the issues affecting delivery, identify practical priorities and help strengthen trial oversight while protecting participant safety, data integrity and regulatory compliance.
Support can range from targeted intervention in one area to broader operational recovery across several functions. The first step is understanding why performance has moved away from plan and what needs to change.
Supporting studies during CRO or operational transition
Changes to the management of an active study require careful control. Poorly managed transitions can create additional risk around study knowledge, documentation, site relationships and outstanding activities.
If PHARMExcel joins an existing study, we first establish a clear picture of current responsibilities, site status, essential documentation, safety obligations and operational risks.
We can then work with sponsors and existing providers to clarify ownership and maintain continuity across the study. The precise scope depends on the trial, the systems already in place and the responsibilities agreed with the sponsor.
Data quality, monitoring and trial integrity
PHARMExcel can combine clinical monitoring, data management and project oversight to identify quality gaps. Depending on scope, this may include closer monitoring, review of outstanding data issues, query management and stronger oversight of recurring protocol or documentation problems. Broader process weaknesses can then be addressed through practical corrective actions agreed with the sponsor.
Corrective actions and stronger study governance
Rescue work should address the causes of underperformance, not only the immediate symptoms. Depending on the assessment, PHARMExcel may recommend changes to project governance, site oversight, monitoring, training, enrolment assumptions, vendor management or study processes.
Responsibilities and priorities can then be clearly defined so sponsors and study teams understand what needs to happen and how progress will be assessed. Formal CAPA activity can also be supported when it falls within PHARMExcel’s agreed study responsibilities.
Regulatory and safety oversight during trial recovery
Operational recovery must remain aligned with participant safety and regulatory requirements and for that PHARMExcel’s clinical operations, regulatory and safety teams work together to maintain oversight of trial-specific regulatory obligations and safety reporting while operational issues are addressed.
Our pre-marketing pharmacovigilance capabilities include adverse event management, serious adverse event processing, medical review, SUSAR reporting and expedited reporting where required. Changes to study conduct that require regulatory or ethics submissions can also be supported through the relevant trial-specific amendment or modification process.
Why sponsors choose PHARMExcel for clinical trial rescue support
Underperforming studies often need close oversight, continuity and access to experienced decision-makers. As a smaller, specialist CRO, PHARMExcel has fewer organisational layers than many larger providers. Sponsors have direct access to experienced senior staff, while clinical operations, monitoring, safety, regulatory affairs, data management and project management can work together around the same study challenges.
PHARMExcel is based in the UK and has strong practical knowledge of UK, NHS, academic and European research environments, while supporting sponsors across the UK, Europe and US. For studies already under pressure, that combination of responsiveness, continuity and practical delivery experience can help create a clearer and more manageable route forward.
Let’s get your study moving forward
Whether you need to transition an entire study, address delays at a critical stage or bring in additional support for specific activities, we will work with you to understand the challenges and agree where PHARMExcel can help.
Talk to us about your study, where progress has stalled and the support you need.
Clinical trial rescue FAQs
What is a clinical trial rescue study?
Clinical trial rescue describes intervention in a study experiencing significant operational, site, enrolment, data quality, monitoring or regulatory problems. The work usually starts by establishing why the study is underperforming before identifying the corrective actions or operational changes required.
When should a sponsor consider clinical trial rescue support?
Sponsors may consider additional support when persistent problems begin to threaten timelines, enrolment objectives, data quality, participant safety or regulatory compliance. Warning signs can include sustained site underperformance, unrealistic enrolment projections, increasing protocol deviations, unresolved data issues or monitoring concerns.
Can PHARMExcel support a study previously managed by another CRO?
PHARMExcel can support an existing study where a sponsor needs additional clinical trial support or a change in operating model. Before taking on new responsibilities, we assess the trial status, documentation, sites, outstanding activities, safety obligations and operational risks. This helps define an appropriate and realistic scope for PHARMExcel’s involvement.
How does PHARMExcel support enrolment recovery?
PHARMExcel first assesses why site-led enrolment is behind expectations. This may include patient population availability, eligibility criteria, competing studies, investigator engagement, screening patterns and site capacity.
PHARMExcel does not directly recruit participants. Instead, we provide governance and oversight of site-led enrolment and use feasibility and site intelligence to help sponsors decide whether the current site strategy remains appropriate.
How can data quality problems be addressed during trial recovery?
PHARMExcel can support monitoring and data management activities relevant to the study, including review of outstanding data issues, query management and protocol deviations. Recurring problems can also be traced back to wider process weaknesses, allowing corrective actions to focus on the underlying cause rather than individual data points alone.
How does PHARMExcel protect participant safety during trial recovery?
PHARMExcel integrates clinical operations with medical and safety oversight so that safety obligations continue to be managed while operational problems are addressed. This may include adverse event and serious adverse event management, medical review, SUSAR reporting and expedited reporting where required.
Can every delayed clinical trial be rescued?
No. The options available depend on the cause of the problem, remaining timelines, site capacity, available patient population, study design and any existing data or quality issues. PHARMExcel therefore assesses the study first and establishes realistic priorities rather than promising recovery before the underlying problems are understood.
How long does clinical trial rescue take?
There is no standard timeframe. It depends on the nature and severity of the problem, number of sites, enrolment status, trial phase, data quality and the scale of any operational changes required. An initial assessment helps establish immediate priorities and a realistic recovery plan.
Why choose a smaller specialist CRO for an underperforming study?
Clinical trial rescue often requires fast decision-making, continuity and close senior oversight. PHARMExcel’s smaller structure gives sponsors direct access to experienced team members and allows clinical operations, monitoring, safety, regulatory and data functions to work together with fewer internal handovers.