- Monitoring of indication-related study parameters according to protocol, trial monitoring plan, etc.
- Verification of compliance with regulatory requirements (Medicinal Products Act - AMG, Medical Devices Act - MPG, GCP, etc.)
- Key contact person for study team and sponsor
Depending on the individual project requirements concerning the monitoring strategy, we can offer you different approaches:
- On-site visits performed by our clinical monitors / CRAs
- Focus on informed consent forms / data protection, SDV - Source Data Verification
- Telephone monitoring / video conferencing
- Focus on SDR - Source Data Review / check of plausibility and completeness of eCRF data or data from other electronic systems
- Risk-based approach - focus on critical data and processes
- Systematic and timely data analysis of eCRF data or data from other electronic systems
- Review by clinical monitors / CRAs, data managers, statisticians
We would also be happy to assist you in defining and developing the monitoring strategy for your project.
Our study assistants - also called flying study nurses - will strengthen the study team at site and will ease their workload accordingly.
Due to their flexibility, optimised support can be provided to the local study teams in form of an efficient and professional co-operation.