Phase II - IV
Full service or modular approach - tailored to your specific needs
Study Preparation
- Protocol design (and CRF) in any indication by our M.D.s and scientific experts
- Selection of "Main / Chief Investigator" (according to national drug law / law on medical devices)
- Submission to ethical committees, submission to / notification of authorities in Europe, customs procedures
- Recruitment of investigators (9,000 investigators in hospitals and practices) and site selection (visits)
Studies conducted in Germany, Western Europe and Eastern Europe with local and central monitors
- Initiation visits, investigator meetings
- Project management, controlling, AE-management
- Monitoring visits according to GCP, FDA standards by our 50 monitors
- Handling of study material, storage, customs regulations
- Quality control, audit
- Remote Data Entry