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At Curex, we go beyond traditional site management by enhancing trial quality, efficiency, and compliance, ensuring GCP adherence while safeguarding patient rights and safety.
Site monitoring is the vigilant eye that oversees the day-to-day conduct of a clinical trial at investigative sites. Its primary objectives are to verify the rights and well-being of human subjects, ensure adherence to the study protocol and regulatory requirements, and confirm the accuracy and completeness of the clinical trial data. CurexBio employs a risk-based approach to monitoring, optimizing resources while maintaining robust oversight.
Our Clinical Research Associates (CRAs) conduct regular on-site monitoring visits to investigative sites. During these visits, CRAs perform comprehensive source data verification (SDV), comparing data recorded in the Electronic Case Report Form (eCRF) against source documents to ensure accuracy and completeness. Key activities include:
This direct interaction is crucial for building rapport with site staff and providing real-time quality assurance.
CurexBio uses advanced technologies to implement remote and centralized monitoring strategies, particularly in a risk-based framework. Remote monitoring involves off-site review of clinical data and documents, while centralized monitoring involves systematic statistical analysis of aggregated data across all sites to identify trends, outliers, and potential issues. These methods improve efficiency, allow frequent oversight, and enable targeted on-site visits.
Effective site monitoring involves timely query resolution and data review. Our monitors carefully examine incoming data for miscalculation, inconsistencies, discrepancies, and protocol deviations. Our monitors generate clear queries and work closely with site staff to ensure accurate resolution, minimizing data cleaning efforts post-database lock and ensuring the integrity and reliability of final study data.
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