Study Monitoring And Site Management

NIBA Research prides itself on possessing a well trained team of monitors being comprised of physicians, chemists, biologists, pharmacists, biotechnologists and nurses to cite but a few. Our monitoring-force is located in 5 medical university towns in Bulgaria.

We provide a wide range of clinical research services at the study site to meet quality and ICH-GCP compliance at the highest level:

• Pre-study documents collection and review
• Site/Investigator identification and selection
• Site initiation
• Monitoring visits and reports
• Source documents review and data verification
• Drug accountability
• Study close-out
• Query Management
• SAE reporting

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