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.