Data in a particular population is obtained irrespective of exposure to the particular drug and the health status of its members. This study allows us to find statistical relationships between exposure to a particular drug, and the fact that people are struggling with a particular disease in a given population.
This study tests a group of patients of a population whose members take a certain medicinal product. The cohort is monitored for predefined medical events at fixed times, and then, at the stage of statistical analysis, the confirmed incidence is compared between the study group and the cohort control group (patients not taking the medication).
Cohort studiesThe study consists of identifying the relationship between an observed medical event occurring at the end point, and a specific type of exposure. Retrospective comparative analysis is performed simultaneously on a group of patients who have had such a medical occurrence, and a control group (with no occurrence of the medical event).
Our team consists of experienced specialists in the field of medical statistics, biostatistics, data management / data mining, as well as IT industry experts and Medical / Pharma Market Research. We also have business and academic experience - it allows us to participate efficiently in observational and clinical research projects, but also to carry out marketing research for pharmaceutical entities or provide them with professional medical records and dedicated software.
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Each of our projects was realized using the dedicated to pharmaceutical and medical industries eCRF.bizTM system. Using our proprietary software is a guarantee of the security of your data – provided by our access encryption module and automated backup systems, as well as by our compliance with FDA standards – Title 21 CFR Part 11. The eCRF.bizTM platform is also equipped with a function that allows it to check the completeness and quality of data, and to continually verify the progress of the project currently underway. Due to its advanced statistical module, it is also possible to carry out comprehensive analyses, and to easily represent the detected dependencies in a easy to read, graphical way.
eCRF.bizTMObservational study that allows us to find detailed characteristics of patients undertaking pharmacological therapies using specific drugs. The study makes it possible to identify a typical population, among others due to socio-demographic and health characteristics. Patient compliance with the recommendations of the Summary of Product Characteristics may also be analyzed.