Medical Device Clinical Trial Management

Some of the medical device clinical trial management services we offer to our customers are;

• Research Protocol Design
• Sample Size Calculation
• Case Report Form Design
• Informed Consent Form Design
• Ethics Committee and TİTCK Application File Preparation
• Center Feasibility and Selection
• Monitoring Management
• Project Management
• Study Materials Inventory
• Researcher Meeting Planning and Coordination
• Center Organization Management
• Data Management
• Data Entry Support Service
• Statistical Analysis and Reporting
• Medical Writing Procedures
• Study Materials Inventory
• Import and Customs Procedures
• Adverse Event/Serious Adverse Event Monitoring and Collection
• Center Specific File Management
• Regulatory File Management
• Laboratory Contract Negotiations
• Revolving Fund Contract Negotiations
• IT and Technical Consultancy
• CE File Preparation
• Clinical Evaluation Report Preparation