Real-World Evidence-Driven Solutions for Pragmatic Trials
At OXON, we combine our extensive experience in Real-World Evidence (RWE), epidemiology and observational research with rigorous clinical trial methodologies to support the design and delivery of pragmatic clinical trials in routine healthcare settings.
From study design and feasibility to trial management, data analysis and reporting, we provide integrated solutions for pragmatic trials evaluating drugs, vaccines, medical devices and other healthcare interventions, bridging the gap between clinical trials and real-world evidence.
PRAGMATIC TRIAL DESIGN
Rigorous Study Methodologies
Designing trials that combine scientific rigour with routine clinical practice.
REAL-WORLD SETTINGS
Routine Healthcare Environments
Conducting trials in routine healthcare settings with diverse patient populations.
RWD
INTEGRATION
Real-World Data Solutions
Leveraging routinely collected healthcare data for efficient trials and evidence generation.
EFFECTIVENESS & SAFETY
Clinical Outcomes
Evaluating the effectiveness and safety of healthcare interventions in routine clinical practice.
Why choose OXON for your pragmatic trials?
We bring together scientific expertise, operational experience and multidisciplinary collaboration to address the complexities of pragmatic trials and deliver meaningful clinical evidence.
Our multidisciplinary team brings together specialists in epidemiology, clinical research, biostatistics and data management to generate reliable evidence that supports healthcare decision-making.
Trial
Management
From feasibility and site selection to trial coordination, oversight, monitoring and final reporting.
Multidisciplinary Approach
Combining epidemiology, clinical operations and specialised data expertise for coordinated trial delivery.
Global
Expertise
International experience in real-world research across healthcare systems and therapeutic areas.
Patient-Centric
Approach
Designing research around routine patient care, with a focus on meaningful clinical outcomes.
Our services
OXON provides integrated scientific, operational and technical support throughout the pragmatic trial lifecycle, from initial study planning to evidence generation and reporting.
Medical and Statistical Consulting
Our scientific and statistical consulting services combine OXON’s expertise in RWE and epidemiology with the guidance of internationally recognised experts, including our Scientific Advisor, Professor Stuart Pocock, renowned for his contributions to clinical trial methodology.
• Pragmatic trial design, including randomised approaches tailored to real-world healthcare settings.
• Feasibility assessments and study population definition.
• Sample size calculations and statistical power optimisation.
• Advanced statistical methodologies, including Win Ratio analysis for clinically prioritised outcomes.
• Integration of RWE and routinely collected healthcare data.
• Strategies to address confounding, bias and missing data.
Clinical Operations:
Our clinical operations team supports the efficient delivery of pragmatic trials in routine healthcare settings:
• Study start-up, site feasibility and selection.
• Site coordination, activation and training.
• Patient recruitment and retention strategies.
• Risk-based monitoring adapted to pragmatic trial designs.
• Trial management, oversight and contingency planning.
Statistical Analysis
We provide rigorous statistical analysis to generate reliable evidence from pragmatic trials:
• Randomisation schedules and allocation methodologies.
• Statistical analysis plans and appropriate analytical models.
• Intention-to-treat and sensitivity analyses.
• Analysis of real-world effectiveness and safety outcomes.
• Statistical reports, tables, listings and figures.
Data Management
We deliver efficient, high-quality data management solutions tailored to pragmatic trials:
• Design and testing of electronic Case Report Forms (eCRFs).
• Integration of routinely collected healthcare data.
• Data validation, cleaning and quality control.
• Patient-centric data collection to minimise site burden.
• Ongoing data monitoring and quality oversight.
Medical Writing
Our medical writing team develops high-quality scientific and regulatory documentation throughout the pragmatic trial lifecycle:
• Study protocols and clinical study reports.
• Scientific publications, abstracts and posters.
• Regulatory documentation and study summaries.
• Clear communication of real-world clinical outcomes.
Regulatory Interactions
We provide regulatory guidance and documentation support for pragmatic trials, helping sponsors navigate applicable requirements throughout the study lifecycle.
• Regulatory strategy and submission support.
• Scientific and methodological documentation.
• Alignment with applicable GCP and regulatory requirements.
• Support for regulatory interactions and evidence generation.