Monitoring

The monitoring of clinical studies is a mandatory ICH GCP requirement. It ensures the respect of the rights, safety and well being of the subjects enrolled in the trial, data integrity and other ICH GCP principles.

The clinical site monitor is the key communication link between the sponsor and the investigator site.

Aepodia provides trained and experienced monitors for Phase I/IIa clinical trials who will:

• Plan and prepare site visits according to the monitoring plan
• Carry out monitoring visits during the active phase of the trial
• Report essential data and provide update on study progress
• Ensure the quick and efficient resolution of issues
• Monitor GCP compliance, identify and resolve GCP-related issues