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In 2010 Sana pharma started offering the conduct of clinical trials after joining all the required expertise in one place and preparing the legal frame for these studies. The following clinical activities can be provided:
- 1. Start up:
- Feasibility study
- Selection of sites and investigators
- Ethics submission
- Regulatory submission
- 2. Conduct:
- Project Management
- Monitoring
- TMF/ISF preparation, handling and maintenance
- Pharmacovigilance and safety reporting
- Ethics and regulatory progress reporting
- IP shipments, handling and storage
- Supplies management
- Data management
- IT support
- Interim analysis (if required)
- Quality Assurance
- 3. Close-out:
- Project management
- Database lock
- Statistical analysis
- Final report
- Close-out reporting to Ethics and regulatory
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