- The basis for GCP-compliant data management at KKS is the EDC (electronic data capture) system MARVIN from XClinical. MARVIN combines all the necessary functionalities, such as an audit trail, with a high level of user-friendliness for programmers and users. The KKS data managers have many years of experience with the system. The KKS uses MARVIN for all types of clinical studies, be it a multicenter study, a monocenter phase II study or a registry.
- Development of the study-specific test forms in close collaboration with the study coordinators
- Programming of the eCRF in the GAMP-5 validated EDC system MARVIN
- Randomization
- User training and support
- Data validation
- Query management
- MedDRA coding
- SAE Reconciliation
- Preparation of data for interim and final reports