Risk Based GCP & GLP Monitoring & Audit/GLP Compliance

 

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.

Our well defined SOPs with separate checklists for the initiation visit, routine monitoring visits, retrospective visit, and a closeout visit provides assured quality monitoring services. We are committed to delivering all checklist and observed issues within a stipulated predefined timeline. Quality evaluation of research partners in terms of capability to adhere to regulatory requirements and meet the expected timeline should be a standard part of the contracting the services. Our well experienced and highly technical auditor available to evaluate the capability of your research partner. Our rigorous auditing process is designed to identify and address issues before your important projects stuck in major problems.

Oxter Research an India Based Pharmaceutical Research Company auditing services are based on the checklist designed by compiling the USFDA, EU, NPRA, ANVISA, TGA, Health Canada, GCP, GLP, and all other applicable regulatory requirements to cover every aspect of regulatory needs.

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