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Expertise - Monitoring

Monitoring

Our scientifically and medically trained monitors handle the central aspects of executing studies. They master challenges and are experienced in dealing with testing centers under all conditions. They ensure the highest of data quality, majorly contribute to patient safety and support the study centers. Written reports are prepared for every monitoring visit conducted and reviewed both internally and externally. This way, difficulties in the study centers are noticed in a timely fashion and ensure that appropriate measures can be taken to counteract the situation. The core aspects of this area are:

  • Pre-study visits
  • Study initiation visits
  • Routine monitoring visits
  • Close-out visits
  • In-house monitoring
  • Support and preparation of institutional inspections in the study centers

Highest principles for our monitoring:

  • Protection and well-being of our study participants
  • Completeness, correctness and replicability of data
  • Control of the proper execution in agreement with the trial protocol, GCP, and current regulations