Medical consulting and project administrationMP900433105

Project administration

  • Consulting services
  • Drawing up CT budget
  • Sites selection
  • Organizing meetings and negotiations with investigators and sites chief managers
  • Assistance in concluding agreement with sites
  • Sites personnel training
  • Regular interactions with Regulatory Authorities and local Ethics Committees
  • Joint monitoring visits
  • Pharmacovigilance
  • Monitoring of test results documents on adverse experience and serious adverse events (SAEs)

Documents producing

Medical writing for clinical studies performance:

  • CT Protocol                                                              
  • CRF (Case report form)
  • Investigator's brochure
  • Patient Information Sheet
  • Informed consent statement

Producing regulatory documents:(Analytical Normative Documents, Basic Prescribing Information (package  leaflet ), description of package design

Producing literary reviews and surveys