- 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