Sélectionner une page

SERVICES

START-UP ACTIVITIES

  • Preparation of operational and project plans
  • Preparation of study related and essential documents
  • Study sites identification, assessment and selection
  • Database implementation

    REGULATORY AFFAIRS

    • Preparation of regulatory dossiers for submission to Ethics Committees and regulatory agencies
    • Follow-up and finalization of submissions for approval
    • Sites coordination for Regulatory approvals
    • Clinical Trial Agreement negotiation and finalization

      PROJECT MANAGEMENT

      • Implement the operational and project plans
      • Patient recruitment according to milestones
      • Ensuring quality data entry in database
      • Managing IMP and study material supply
      • Clinical monitoring activities

      SITE MANAGEMENT

      • Training on study for study staff
      • Site Initiation Visits
      • Ensure maintenance of study documentations on sites
      • Safety event reconciliation, coordination and management
      • Quality management

      STUDY CLOSE-OUT

      • Preparation of final clinical trial reports
      • Close out visits
      • Study archiving management
      • Inspections and audits preparation
      • Assistance in final results analysis and presentation

        OTHER ACTIVITIES

        • Management of contractual aspects
        • Management of financial aspects
        • Obtaining local insurances
        • Quality assurance and control
        • Vendor management