Clinical studies

CONDUCTING OF CLINICAL AND BIOEQUIVALENCE STUDIES

Medical writing
• Protocol
• IB
• CRF
• ICF
Feasibility study
• Search for clinical sites
• Search for research and diagnostic laboratories
• Accreditation maintenance of clinical sites

Preparing and conducting a clinical trial
• Conclusion of a contract with the center
• Conclusion of a contract with an investigator
• Conclusion of a contract with the laboratory
• Conclusion of a contract with an insurance company
• Granting approval to conduct Clinical trials (including dossier preparation)
• Local Ethics Committee (LEC) approval
• IMP management
• TMF/ISF development
• Printing of ICF, CRF
• Investigators training
• Start-up Meeting

Research monitoring

• SIV (Site Initiative Visit)
• RMVs (Routine Monitoring Visits)
• CMV (Close-out Monitoring Visit)

Final Stage

• Data management
• SAR (Statistical Analysis report)
• CSR (Clinical Study Report)
 
Development of electronic Case Report Form
• Database specification development
• Database development
• Development of a data management plan
• Development of guidelines for the Case Report Form filling
• Development of a data validation plan