Medical Services
The clinical development of an investigational medicinal product is a very complex, costly, and risk-involving process. The establishment of appropriate procedures and the implementation of high-quality training ensure compliance with legal mandates and will be of utmost importance for the success of the project.
Medical services related to clinical development offered by HilbransConsulting include:
- Planning and establishing of pharmacovigilance processes in clinical trials (SAE Reporting Flow)
- Medical and quality review of trial documents (e.g. protocol, CRF, patient information, report)
- Medical monitoring of protocol compliance
- Data reconciliation, query resolution
- Medical coding (MedDRA)
- Organisational support for Data Monitoring Committees
- Drug safety training for investigators, monitors etc.