Study Monitoring
Equilab's study monitors coordinate all aspects of clinical monitoring activities, including Site Initiation Visits (SIVs), Monitoring Visits (MVs), Remote Monitoring Visits (RMVs), and Close-out Visits (COVs). We ensure that monitoring activities are conducted efficiently and in accordance with study requirements, GCP guidelines, while providing ongoing support and oversight to site staff and study personnel.
Close-out Visit (COV)
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The COV is the final visit we conduct after all study-related activities have concluded. Our goal is to formally close the site and ensure all documentation and materials are finalized. We perform a final data reconciliation to ensure the study database is complete and ready for analysis, and we meticulously review all remaining study materials. This final, thorough check ensures that all necessary documents and investigational products are properly accounted for.
Remote Monitoring
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Remote monitoring is a flexible and efficient approach that complements on-site visits. By leveraging technology, we can provide more frequent oversight to maintain close contact with your site team without the need for physical travel. We'll remotely access your study database to review data for accuracy and consistency, while also communicating with site staff via video calls to address any questions and resolve data queries quickly.
On-site Monitoring Visits are the core of our ongoing oversight. The main purpose is to ensure data integrity, patient safety, and GCP compliance throughout the trial's enrollment and treatment phases. Our monitors meticulously perform Source Data Verification (SDV), comparing data in the Case Report Forms (CRFs) against original patient source documents to verify accuracy. We also perform thorough reviews of all regulatory documents and reported adverse events to ensure they are being managed correctly.
On-site Monitoring Visit (MV)
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Site Initiation Visit (SIV)
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The SIV is our crucial first step to activating a clinical site. The primary goal is to train the entire site team on the study's protocol and procedures before a single patient is enrolled. We'll provide comprehensive training to all site staff on protocol specifics, enrollment criteria, and how to manage potential adverse events. We also confirm that all essential regulatory documents are complete and properly filed, ensuring the site is fully prepared for a successful trial launch.