Monitoring
MEDIKAPOLI CRO provides comprehensive Clinical Monitoring services to ensure that clinical trials are conducted in accordance with approved protocols, regulatory requirements, and international quality standards. Our experienced Clinical Research Associates (CRAs) perform monitoring activities throughout the study lifecycle to safeguard patient safety, data integrity, and regulatory compliance.
We conduct on-site, remote, and risk-based monitoring visits, including site initiation, routine monitoring, and close-out visits. Our monitoring activities focus on source data verification, protocol adherence, informed consent compliance, investigational product accountability, and timely reporting of safety events.
Through a structured and risk-based monitoring approach, MEDIKAPOLI CRO helps identify and address issues proactively, minimize deviations, and maintain high-quality data, ensuring full compliance with ICH-GCP and local regulatory requirements.