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Clinical Investigations Ltd provides the complete clinical operation services for all stages of drug development.
- Design of protocol, CRF, and documentation needed for trial approval in Central and Eastern Europe
- Development of the statistical plan
- Sample size calculation
- Feasibility studies
- Regulatory procedure with competent authorities, central and/or local Ethical Committees
- Project Management
- Time-line and budget control
- Monitoring
- Data entry, data management, data verification and validation
- Electronic data capture
- Statistic evaluation and reporting
- Pharmacovigilance with 24/7 response line
- Safety surveillance of Clinical Trials
- Publication of the manuscript
- Submission and handling of publication
These services are provided for:
- drugs,
- medical devices,
- cosmetics,
- healthcare products.
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