Services
■ Drug Development
- Drug development plan, product profiling and positioning
■ Clinical Research
- Clinical trial design and protocol writing
- Quality by design
- Quality Risk Management (QRM)
- Phase I to IV studies, NIS, IIS and PMOS
- Study management, coordination and supervision of CRO(s)
- Established international service provider NetWork
- Planning and coordination of advisory boards and investigator meetings
■ Regulatory Affairs
- Ethical committee and Health Authority submissions
- Legal sponsor representative in Switzerland for international sponsors
■ Medical Writing
- Study protocols
- Clinical study reports
- Publications
- Benefit/risk plans
■ Medical Affairs
- Marketing concepts, business strategy and launch plan
- Product promotion, sales strategies
- Life cycle management
- Line extensions
- Medical training
■ Quality Management
- Quality Risk Management (QRM)
- Quality Management Systems (QMS)
- Standard Operating Procedures (SOP)
■ Training and Coaching
- Trainings (GCP, SOP, QRM, clinical trial management)
- Moderating workshops
- Tutorial for new employees and clinical operation teams
- Coaching of Individuals and teams
