Service

Medical Monitoring

Our professional medical monitors can help the project team to better understand the objective, inclusion & exclusion criteria and process of the clinical trial, provide medical support for the project team, and ensure that subjects are safe and that clinical trial data are accurate and scientific. The medical monitoring team will provide the following services for the client:

Service Scope:

1. Draft/update the medical monitoring plan

2. Medical training (medical monitoring plan/protocol interpretation/knowledge of relevant disease areas)

3. Subject enrollment review

4. Regular medical monitoring meeting

5. Protocol violation/deviation review

6. Medical review for clinical data (adverse events, laboratory data, vital signs, medical history, and past medical history, etc.)

7. Medical counseling/Q&A Log maintenance

8. Review of clinical trial-related materials (clinical trial protocol, clinical summary report, and case report form, etc.)

9. Review of laboratory alert values

10. Data cleaning before database locking