Clinical
Monitoring
Our Clinical monitoring team is structured to meet your individual needs, and this customized approach produces excellent monitoring services throughout the duration of the project.
Our Clinical monitoring team ensures the adherence with standard operating procedures and makes every effort to maintain a relationship with a high level of trust and confidence with the customers.
During the clinical monitoring, our CRA makes sure that:
• The rights and well being of human subjects are protected.
• The conduct of the trial is in compliance with the approved protocol, GCP, and the applicable regulatory requirements.
• The data are correct, complete, and supported by authentic source documentation.
• Review the CRFs and source documents for adverse events and serious adverse events
• Perform drug accountability
• Ensure appropriate informed consent process is being followed
• Evaluate investigator study files for completeness
• Ensure investigator compliance with the study protocol
Our CRAs call investigators regularly to review study progress, confirm patient enrollment status, answer study related questions, discuss CRF completion and ensure the study meets the timelines.
Our Services »
International Collaboration with
X-Lab (S) Pte, Singapore |
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