Clinical researches

Clinical monitoring

  • clinical trial protocol and other documentation submission to the ethics committee and regulatory authority
  • site identification and assessment
  • training of investigators and their teams on protocol and clinical trial aspects
  • clinical trial oversight in order to assure compliance with the protocol and applicable regulatory requirements (site initiation visit, monitoring, close out visit).
  • study logistics, customs clearance procedures

Pharmacovigilance

  • clinical safety
  • pharmacovigilance system including EU-QPPV
  • local pharmacovigilance representation