Monitoring is a quality control. The monitor ensures that laws and regulations are followed and that data is correctly recorded in the patient's data collection form - CRF.
UCR's monitors have long experience of clinical trials in a wide range of therapeutic areas. We plan monitoring based on the regulatory requirements and guidelines provided by the International Conference of Harmonization - Good Clinical Practice, ICH-GCP and the Medicines Agency Constitution LVFS 2011: 19.
We have developed a process for working with risk-based monitoring but also offer more traditional monitoring with visits before, during and after the study.