Good Clinical Practices with ethical and scientific evaluation is applied in all studies. The approval from the National Agency for Medicines is also required.
Participation in drug development studies is always voluntary for patients and their informed consent is mandatory. Most patients find it positive that they are treated by specially trained personnel and the latest drugs.
The continuous education makes the work rewarding for fhe doctors and nursing staff.
Moreover, society as a whole benefits from the studies when the companies in question take care of the costs of the studies and drugs.
Monitoring service for investigator-initiated clinical studies
Clinical Research Institute HUCH Ltd offers monitoring services for investigator-initiated clinical studies.
Regular quality control is performed according to the regulatory requirements, the principles of good clinical practice (ICH-GCP) and the standard operating procedure of Clinical Research Institute HUCH Ltd. The investigator can determine the level of needed quality control in the study.
The investigator should contact the study monitor in early stage when planning a clinical study. The level and nature of monitoring are determined separately for each study in a study specific monitoring plan.