- Selection and recruiting of investigators - Selection of other facilities such as study sites and laboratories - Pre-study visits and facility check - Investigator and study participant trainings - Study initiation visits - ATCs
Clinical phase
- Monitoring: regular monitoring visits, reports and actions on on-site problems, etc. - Regular telephone contacts with all study participants - Regular sponsor updates (patient status, recruitment, monitoring activities etc.) - Study file management - Data query handling - Management of investigators and other study participant`s fees - Logistics (national and multinational) for sample transport, drug and material supply - Control of drug administration - Contact to authorities - Monitor QC - Data entry - Control of timelines
Evaluation phase
- Quality control - Control of timelines - Statistical analysis - Final report
