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Clinical services - trial initiation |
| We can initiate and coordinate all operational aspects of your trial. This includes: - Protocol and informed consent design
- CRF design, data management, data analysis (statistics, pharmacokinetics ) and reporting
- Site selection, contracting, insurance
- Packaging, labeling, import and storage of trial medication
- Set-up of randomization procedure
- Filling out EudraCT application forms, submission of documentation to ethics committees and competent authorities
- Pharmacovigilance
- Bioanalysis and sample shipment
- Site monitoring
- Trial master rile preparation and archiving
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