Monitoring the research data and procedures
The purposes of trial monitoring are to verify that:
a) The rights and well-being of human subjects are protected.
b) The reported trial data are accurate, complete, and verifiable from source documents.
c ) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. Penthecilia provides monitoring procedures conform ICH-GCP and the WMO.
Our services include:
- Design a monitoring plan
- Perform source data verification
- Perform site initiation visits
- Verify the study administration
- Verify study procedures