Real-World Data-Driven Solutions in Clinical Trials
“At OXON, we bring our extensive experience in RWE and observational studies to the realm of clinical trials, offering comprehensive solutions for managing Phase I-IV research”
From initial concept through to regulatory approval and post-market surveillance, we offer end-to-end solutions to face your clinical research challenges, covering all phases (I–IV) with precision, expertise, and a commitment to delivering impactful results.
PHASE I
Early Safety and Dosage Studies
First-in-human studies to assess safety, pharmacokinetics, and pharmacodynamics.
PHASE II
Efficacy and Side Effect Assessment
Studies focused on assessing the efficacy of the drug and continue safety monitoring.
PHASE III
Confirmatory Studies
Large-scale trials to confirm efficacy, monitor long-term safety, and compare with standard treatments.
PHASE IV
Post-Surveillance
Studies to monitor large-scale safety and effectiveness once the drug is available to the general population.
Why choose OXON for your clinical trials?
We integrate operational expertise with scientific rigor to support pharmaceutical companies and biotech firms in advancing healthcare solutions.
Our team of experts combines industry-leading knowledge, cutting-edge methodologies, and a global network to deliver trials that exceed regulatory expectations and deliver impactful results.
Trial Management
From feasibility and site selection to regulatory submissions and final reporting.
Seamless Integration
Bridging interventional and observational research to maximize study value.
Global Expertise
Proven success in multi-country trials across diverse therapeutic areas.
Patient-Centric Approach
Dedicated to ethical research and enhancing patient outcomes.
Our services
Our services include full-service support and consultancy across Phases 1–4, backed by a team with 100+ publications in NEJM and Lancet, and expertise in a new FDA-approved method to enhance study power.
Medical and Statistical Consulting
We support your clinical trial study and programme with a tailored and strategic approach:
• Phase I-IV trial design (including adaptive and sequential designs).
• Use of RWE and historical data to plan trials and create external controls.
• Optimal sample size calculations for efficacy and safety studies
• Regulatory support, including FDA interactions..
• Win Ratio methodology to increase study power.
Clinical Operations:
Our expert team handles all aspects of clinical trial operations, including:
• Study design & protocol creation with input from world-leading experts
• Feasibility and site selection to ensure diversity in patient populations, particularly in the U.S.
• Patient recruitment & retention strategies, including patient-centric approaches and site support.
• Trial management, including site training, monitoring, and risk management
Study risk management and contingency planning to ensure smooth operations.
Statistical Analysis
We provide world-class statistical support for every phase of your trial:
• Sample size calculations and Randomization Schedules.
• Statistical analysis plan with optimal statistical models and analyses.
• Regulatory submission-ready datasets.
• Clear tables, listings and figures for study reports and publications.
Data Management
Maximizing data quality is key to trial success:. We use state-of-the-art systems to ensure seamless data collection and real-time updates, ensuring you stay on track at every stage.
• Design and test e-CRFs for easy, efficient data collection.
• Patient-centric data entry to reduce dropout rates and site burden.
• Ongoing review of data for quality, enrollment, and compliance.
• Real-time metrics on data quality and participant characteristics.
• Blind data management for Data Monitoring Committees (DMC).
Medical Writing
Our expert medical writing team produces high-quality regulatory documents and publications:
• Clinical study reports.
• Journal articles, abstracts, and posters for publication in top-tier media.
• Regulatory submission documents (ISS/ISE reports, clinical summaries).
Regulatory Interactions
We help you successfully engage with regulatory bodies, ensuring your trials are designed for approval navigating the complexities of FDA, EMA, and MHRA interactions.
• Expert support for regulatory submissions.
• Specialized experience in key therapeutic areas such as CVRM, oncology, neurology, and rare diseases.
• Use of the Win Ratio methodology to enhance study power and improve regulatory outcomes.