We offer high quality monitoring services to clients for all types of monitoring activities. All monitoring activities are conducted in accordance with ICH-GCP and applicable regulatory guideline requirements.
During monitoring:
- The rights and well-being of human subjects are protected.
- The reported trial data are accurate, complete, and verifiable from source
- The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Types of monitoring services:
- Site identification and Site initiation
- Clinical phase monitoring (Check-in and dosing)
- Bioanalysis monitoring (MD/MV data review and in process analysis monitoring)
- Site close out
- Biostudy results assessment / review (retrospectively)
- Retrospective Monitoring Visit
- Risk Based Monitoring