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Monitoring, which is conducted by CRAs, is one of the most important activities that are carried out in new drug development. The CRA is responsible for visiting the medical institution that is implementing the clinical trial and explaining the study drug, the protocol, and the procedures. Following the start of the clinical trial, the CRA will monitor the trial to ascertain that it is accurately conducted according to the established procedures, and will collect the data. At Linical, we employ many CRAs, with management-level experience in the development divisions of major pharmaceutical companies, who are proficient in new drug development and medical knowledge as well as related laws and regulations. This allows us to provide highly accurate and reliable data.
CRAの業務内容
  • Solicit and confirm contracts for clinical trials
  • Explanation of the GCP, clinical trial execution plan sheets, and clinical trial drug outline sheets
  • Check issues regarding clinical trial drugs and control status.
  • Request integration of clinical cases
  • Confirm clinical trial execution status (effectiveness and safety)
  • Create a clinical case report, explain the outline, and request its creation
  • Verify original material (SDV *1)
  • Check case reports for consistency
  • Collect clinical case reports
  • Collect any leftover drugs used in the trial
  • Clinical trial termination procedures
  • *1: SDV (Source Data Verification) refers to the verification of source materials (clinical records, etc.) relating to clinical case reports and clinical trials.
モニタリング業務