Detailed development of clinical study design and preparation of high-quality documents for the study is the key to the successful registration of a medicinal product. The properly prepared clinical study protocol will allow obtaining high-quality valid data, which allows estimating efficacy and safety of a medicinal product, and then the risk-benefit ratio for decision-making about registration of a medicinal product in Russia, EAEU, CIS, EU.
One of the key tools used in clinical trials is biostatistics. Biostatistical methods are used both at the stage of study planning and during the processing of the data arrays obtained in the course of the study.
X7 Research can help in strategy development of interventional studies, preparation of literature reviews, preparation of post-marketing and non-interventional study concepts. Our medical writing experts (medical writers) have extensive experience in developing clinical trial documents. We will help in the selection of the study endpoints, justification of the required sample size, and selection of correct statistical methods for the analysis of the efficacy and safety parameters of the investigational product.