Non-interventional study (NIS)

Non-interventional studies (NIS):
 Research that meets the following requirements:
 a) the drug is prescribed in accordance with the patient information leaflet;
 b) the decision to prescribe a specific treatment to the patient is not made in advance according to the research protocol, but corresponds to the accepted
practice, and a clear distinction is made between the prescription of the drug and 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 [Technical code of
common practice (TKP) 564-2015 (33050). Good Pharmacovigilance Practice].

 We provide the following services:
• Medical writing
• Search for clinical sites
• Local Ethics Committee (LEC) approval
• Overall project management
• Monitoring
• Data Management
• Statistics
• Development of a final report
• Writing publications