Medical writing

• Protocol
• IB
• CRF printing
• ICF

Feasibility study

• Search for clinical centers
• Search for research and diagnostic laboratories
• Accreditation of the accreditation of clinical centers

Preparatory stage

• Conclusion of an agreement with the center
• Conclusion of a contract with the laboratory
• Conclusion of an agreement with the insurance company
• Obtaining permission to conduct ki (with the preparation of a dossier)
• Obtaining the approval of LEK
• The import of the studied drug
• Preparation of the research file
• Print ICF, CRF printing
• Preparation of materials for learning, research team training
• Conducting a starting meeting

Study Monitoring

• Conducting the initiative and closing visits
• Conducting intermediate monitoring visits

Clinical study report

• Data management
• Conducting statistical analysis
• Preparation of an integrated clinical test report

Development of electronic CFM (on the basis of OpenClinic)

• Development of a database specification
• Creating a database
• Development of a data management plan
• Development of a manual for filling out IRK
• Development of a validation plan