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.