Clinical study design
A well-designed clinical study is central to the appropriate collection of evidence related to a new product, service, or device. The outcome and data collected during such studies will be integral to your HTA submission and will be crucial to subsequent market access considerations and payer assessments. It is also a complex task that requires an understanding of various technical, clinical, and social factors.
Whether observational or experimental, we will support and assist you in the design of clinical studies that will generate valuable and reliable data to demonstrate the benefits of your product. Our team of clinicians and statisticians will help you to design the following types of clinical studies in compliance with health regulations in your area:
• Clinical trials;
• Community trials;
• Field trials;
• Cohort studies;
• Case-control studies;
• Cross-sectional studies.
Data collection assistance
You may already have designed your clinical study but require assistance in designing appropriate data collection forms to capture relevant clinical and economic information. Our team of statisticians and health economists will assist you in the design and implementation of detailed, easy-to-use data collection forms which are most suitable for your study. We will ensure that your data collection forms correspond to your needs and can provide sufficient security if being used on digital platforms.
Population sample size estimation
Sample size estimation is an important step in the design of your clinical study. It is necessary to accurately assess your sample size to understand your clinical study’s cost, timelines, and statistical power. Our team of statisticians and clinicians will support you in estimating the population size that is most appropriate for your study.
At Optimax Access, we understand that an appropriate patient recruitment strategy is crucial to ensuring that eligible patients are identified, approached, and recruited in an efficient, scientific manner. Our team of consultants will assist you in establishing the correct recruitment guidelines and in conducting effective and timely patient recruitment for your clinical study.
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