Development of medical documentation and biostatistics

  • Study design development
  • Fast project start-up
  • Extensive experience in both clinical and non-interventional studies in Russia, EAEU, CIS, EU

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.

STUDY PLANNING PROCESS OPTIMIZATION

PREPARATION OF ALL NECESSARY MEDICAL DOCUMENTATION

ACCURATE SAMPLE SIZE CALCULATION

The company X7 Research provides a full range of services on solving problems of medical documentation writing and biostatistics, arising in the process of clinical research. Employees of the scientific department regularly pass training on the application of modern techniques and software products and have many years of experience in applied and scientific work.

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