Clinical Research Services

For clinical research;

  • ♦ Management of Early Access Programme (Compassionate Use),
    • • Support to Regulatory process (submission/approvel of the study, patient and import licence)
    • • Custom process
    • • Informed Consent requirements
    • • Patient selection and randomisation process
    • • Study assessment
    • • Monitoring Requirements
    • • Training responsibilities
    • • Safety issues and AE/SAE reporting procedures
  • ♦ Data entry Services, SMO services,
  • ♦ Organization and conduct of Moderator Services Agreements.