Clinical Research Unit
Regulatory affairs and medical writing
- Documentations writing and preparation for Ethics committee and Swissmedic submissions
- CTA and MTA
- Protocol and ICF
- Safety data reports
- CRF
- Patient information leaflets
Project Management
- Coordination
- Budget and Timelines
- Recruitment through our direct contact (in-house)
Data Management
- Electronic data capture
Site Management
- Site Identification and Selection
- Site Initiation
- Safety and Quality Monitoring
Safety and Quality monitoring
- GCP compliance
Consulting
- Clinical development strategy and management
- Conceptualization, implementation, and management of Phase I and Phase II trials
- Regulatory authority submissions
- Medical, Scientific and technical expertise