Clinical operations
Biometry
Vigilance
Clinical Operations
- Study design & Medical writing
- Regulatory expertise
- Pre and post-market studies
- Early access program (« Accès précoces
et compassionnels »)
- Real World Evidence (primary & secondary data collection)
- Digitalized monitoring
- Decentralized studies
Biometry
- Methodology
- eCRF conception
- Data management
- Statistics
- CDISC implementation
- Data visualization
- Scientific communication
Vigilance
- Multi-vigilance for clinical studies and post marketing
- Vigilance database
- Case management
- Reporting to authorities
- Safety reports
- Data Safety and monitoring Board (DSMB) / Independant Data Monitoring Committee (IDMC)