Description
Creation of documentation.
Familiarization with the study and the necessary training for staff.
Preparation for the study (including budgeting centers).
Coordination of research and workflow.
Obtaining permits for research and conclusion of contracts.
Selection of research centers.
Monitoring research.
Safety reports.
Data processing.
Project management (Project Manager).
Quality control services.
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Preparation of a set of documents to the ethics committee of the Ministry of Health of the Russian Federation for obtaining permission for a clinical trial (protocol, brochure, etc.) |
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Research tests conducted to study the characteristics of the test object - a medical device |
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Research tests carried out to study the characteristics of the test object - the drug , including: |
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Bioequivalence study ( Note : shows the average value per 1 volunteer and 18 sampling points ) |
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Phase I clinical trials ( Note: the average value per 1 patient-volunteer is shown, the actual price depends on the study design ) |
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Phase II clinical trials ( Note: the average value per patient is given; the actual price depends on the study design ) |
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Phase III of clinical trials, including therapeutic equivalence ( Note: averaged value per patient per patient; actual price depends on study design ) |
Part of the SMO is the preparation of a package of documents (protocol, patient information sheet, KFM) of communication with LEC, conclusion of contracts, payment coordination, project management, maintenance of clinical center files, data management, etc.
Clinical part of the study
- hospitalization
- carrying out laboratory tests
- payments to study participants
