Full-service CRO for Clinical Development

Strong delivery starts with the right plan. We work with your team to translate scientific objectives into a clinical development strategy that is grounded in evidence, aligned with regulatory expectations and realistic to deliver.

Our input can begin before the protocol is written. We help define the questions the study needs to answer, assess the available evidence and identify decisions that could affect later development. Clinical, regulatory, operational and statistical perspectives are brought together early, so feasibility is considered alongside scientific ambition.

Our support includes:

• Clinical development plans and regulatory pathways
• Protocol and study design
• Scientific advice meeting preparation
• Statistical input and sample-size planning

Feasibility should test the assumptions behind a study, not simply confirm that sites are interested. We assess where the target population can realistically be reached, how the protocol fits local clinical practice and what could affect recruitment, retention or site performance.

Our local teams combine country intelligence with investigator and site-level insight. We consider competing studies, standard of care, referral pathways, start-up requirements, site resources and the practical demands of the protocol. This gives you a clearer basis for selecting countries and sites, including an honest view of where the study may not work.

The resulting strategy connects patient access, regulatory timelines, site capability, logistics and cost, helping you make country and site decisions before assumptions become delivery risks.

Our support includes:

• Country and regulatory landscape assessment
• Patient population and recruitment analysis
• Site identification, qualification and capability review
• Start-up, logistics and supply considerations

Regulatory strategy shapes what can be delivered, when and where. Our Regulatory Affairs teams work alongside clinical, scientific and operational colleagues to keep regulatory decisions connected to the wider development plan.

We support the preparation, review and submission of clinical trial applications and related documentation across Europe, including submissions through CTIS and national routes in countries outside the system. Our in-country knowledge helps us anticipate local requirements, manage questions from authorities and ethics committees and maintain submissions as the study evolves.

Beyond the initial application, we provide regulatory intelligence, support substantial modifications and help your team respond clearly when requirements or development plans change.

Our support includes:

• Regulatory strategy and pathway planning
• Clinical trial applications and supporting documentation
• CTIS and national submissions
• Ethics committee and regulatory authority interactions
• Substantial modifications and ongoing regulatory support

A named project manager connects the people, decisions and dependencies across your study. From set-up to close-out, they maintain the delivery plan, coordinate functions and vendors and keep progress visible against agreed timelines, budgets and milestones.

Governance, responsibilities and escalation routes are agreed at the start. We track recruitment, site performance, quality signals, risks and critical dependencies throughout delivery. When something changes, we explain the likely impact and bring forward practical options, so decisions can be made with the right information.

For larger or more complex programmes, additional clinical management and cross-study oversight can be built into the model while keeping accountability clear.

Our support includes:

• Project, communication and governance planning
• Timeline, budget and resource oversight
• Cross-functional and vendor coordination
• Recruitment and delivery tracking
• Risk, issue and escalation management

Good monitoring protects participants and strengthens the quality of the data reaching your database. Our CRAs work closely with investigators and site teams from qualification and initiation through routine monitoring and close-out.

Monitoring is planned around the risks of the study rather than applied as a standard checklist. Our teams review informed consent, protocol compliance, source data, safety reporting, investigational product management and essential documentation, while following deviations and actions through to resolution.

Continuity matters. Where the delivery model allows, the CRA who supports a site through start-up and initiation continues as its monitor. This reduces handovers, builds stronger site relationships and helps emerging issues surface earlier.

Our support includes:

• Site qualification, initiation, monitoring and close-out
• Site training and ongoing support
• Risk-based monitoring
• Source data, informed consent and essential document review
• Protocol deviation and action tracking

Our medical monitors provide clinical oversight throughout the study, supporting participant safety and consistent medical decision-making. They work alongside project, monitoring, data and safety teams, giving sites and study colleagues access to timely medical guidance.

Their work includes the review of clinical and laboratory data, adverse events, eligibility questions, protocol deviations and emerging safety trends. They assess the medical significance of findings, support escalation and help determine whether further action or reporting is required.

Medical monitors can also contribute to protocol development, therapeutic training, safety review meetings and the review of patient narratives, tables, listings and other clinical outputs.

Our support includes:

• Ongoing medical and safety data review
• Eligibility and protocol deviation assessment
• Medical guidance for sites and study teams
• Therapeutic training and safety review meetings
• Review of narratives, tables, listings and clinical outputs

Reliable analysis depends on data that are complete, consistent and traceable. Our clinical data management team plans how data will be collected, reviewed and reconciled from study set-up through database lock.

We design case report forms and electronic data capture systems around the protocol, with edit checks and review processes focused on the data that matter most. During conduct, we manage queries, code clinical terms, reconcile external sources and work with sites and study teams to resolve discrepancies efficiently.

Clear data management plans, controlled database changes and documented quality checks support an orderly lock and provide a reliable foundation for statistical analysis and reporting.

Our support includes:

• CRF and EDC design
• Database build, validation and change control
• Data cleaning and query management
• Medical coding and external data reconciliation
• Database quality review and lock

Our biostatistics team contributes from study design through analysis and reporting, keeping statistical decisions connected to the scientific and clinical questions behind the programme.

At the planning stage, we support study design, endpoint selection, power and sample-size calculations and the statistical sections of the protocol. During delivery, we prepare randomisation schedules and statistical analysis plans before database lock, with methods and outputs agreed in advance.

Following lock, our teams deliver the agreed analyses and help interpret the results for clinical study reports and regulatory discussions.

Our support includes:

• Study design, endpoint selection and sample-size calculations
• Randomisation schedules and statistical analysis plans
• Interim and final statistical analyses
• ADaM datasets, SAS programming, tables, listings and figures
• Pharmacokinetic analysis, pooled analyses and regulatory responses

Our medical writers turn complex scientific and clinical information into documents that are clear, consistent and fit for their purpose. They work with medical, regulatory, statistical and operational colleagues so that the content reflects both the evidence and the realities of the study.

We prepare and maintain protocols, amendments, investigator brochures, informed consent forms and patient information. As studies progress, we support subject narratives, clinical study reports, literature reviews and clinical expert reports, incorporating statistical outputs and medical interpretation into one coherent account.

We also help communicate results through manuscripts, abstracts, posters and scientific presentations, with the level of support adapted to the audience and publication plan.

Our support includes:

• Protocols and amendments
• Investigator brochures and informed consent materials
• Subject narratives and clinical study reports
• Literature reviews and clinical expert reports
• Manuscripts, abstracts, posters and presentations

Our Safety and Pharmacovigilance teams help sponsors meet their responsibilities for participant protection, safety surveillance and regulatory reporting during clinical development and after marketing authorisation.

For clinical trials, we establish clear safety responsibilities and processes, manage individual case processing and support expedited and periodic reporting. This can include safety management agreements, DSURs, line listings, EudraVigilance reporting and coordination with investigators, partners and regulatory authorities.

Post-authorisation support is defined around the product, territories and sponsor’s existing pharmacovigilance system.

Our support includes:

• Clinical trial safety management and case processing
• Safety management agreements and expedited reporting
• DSURs, PSURs, line listings and EudraVigilance reporting
• Risk management plans and pharmacovigilance system documentation
• Safety database, QPPV and local contact person services

Quality is built into delivery from the start. Our independent Quality Assurance function provides oversight outside the operational study team, helping identify risk, strengthen processes and maintain inspection readiness throughout the programme.

We conduct investigator site, vendor, system and study audits based on the needs and risk profile of the work. When quality events occur, we support investigation and corrective and preventive actions that address the underlying cause, not only the immediate issue.

Our teams also provide GxP training, document control, trial master file oversight and preparation for regulatory inspections. The aim is a quality system that supports reliable delivery every day, rather than one reconstructed when an inspection is announced.

Our support includes:

• Investigator site, vendor, system and study audits
• Inspection readiness and regulatory inspection support
• Quality event investigation and CAPA management
• GxP training and document control
• Trial master file oversight