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project Management

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)