Non-interventional studies

Non-interventional study (NIS) – a study/trial, which meets the following requirements:

a) the drug is administered by the instructions for medical use;

b) the decision to prescribe a certain treatment to a patient is not made in advance according to the Study Protocol but is consistent with accepted practice, and the prescription of the drug is separated from the decision to include the patient in the study;

c) no additional diagnostic or control procedures are applied to patients, and epidemiological methods are used to analyze the data obtained.

X7 Research has extensive experience in conducting non-interventional studies in various therapeutic areas. Proper planning and careful conceptualization are very important to obtain the best results for a non-interventional study.

PREPARATION OF MEDICAL DOCUMEN-TATION

SUPPORT DURING ALL STAGES OF THE STUDY

SCIENTIFIC ARTICLE WRITING

The X7 Research team has extensive experience in conducting non-interventional studies in Russia, EAEU, CIS, EU. We work by the latest legal requirements in the field of drug circulation.