GLP Monitoring is an essential activity to ensure the quality of the clinical trials, and also we understand issues at both CRO and sponsor levels. Our well qualified and trained monitors are responsible for ensuring that the study conducted in accordance with the protocol, GCP, GLP, and applicable ethical and regulatory requirements. Our team can fully integrate into the study teams of sponsors or CROs while the conduct of the study, nonetheless monitors are independent of the personnel performing the study. We provide a written report after each site visit.
If any issues observed during monitoring, our expert communicates to the CRO and Sponsor as quickly as possible, to mitigate the observed problems. We also suggest and enable prompt corrective actions to mitigate the risk associated with the issues. Such communications and corrective actions shall be documented and provided to the Sponsor.
