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.