What we can do for you:
We support your clinical trial according to ICH-GCP, the pharmaceutical law and all other regulations.
Clinical trial planning
Clinical trial planning
- Protocolldevelopment
- CRF - Design
- Oversee and evaluate subject enrollment
- Recruitment of the investigators and sites
- Assistance in obtaining the votes from the institutional review board/independent ethics committee
- Announcement of the study
- Study-Start and Initiation-Visit
- Fee-agreements
- Organisation of all drug related jobs
- Monitoring-reports
- Report of (serious) unexpected adverse events or unknown adverse drug reactions
- Final study reports
- Preparation of the data-dase
- Independent double-data-entry
- Data-cleaning and query processing
- Delivery of the final database to the sponsor