Clinical Research Unit

Regulatory affairs and medical writing

1. Documentations writing and preparation for Ethics committee and Swissmedic submissions
2. CTA and MTA
3. Protocol and ICF
4. Safety data reports
5. CRF
6. Patient information leaflets
    

Project Management

1. Coordination
2. Budget and Timelines
3. Recruitment through our direct contact (in-house)
    

Data Management

1. Electronic data capture
    

Site Management

1. Site Identification and Selection
2. Site Initiation
3. Safety and Quality Monitoring
    

Safety and Quality monitoring

1. GCP compliance
    

Consulting

1. Clinical development strategy and management
2. Conceptualization, implementation, and management of Phase I and Phase II trials
3. Regulatory authority submissions
4. Medical, Scientific and technical expertise