clinical trials made easy
Monitoring at FreeCRA
Depending on the nature of the clinical project (interventional or not), its complexity and the type of investigators involved, we conduct a risk analysis and assessment for all studies in order to define the best risk-based monitoring strategy.
From the importance of
Monitoring in Clinical Trials
1. Site Selection and Initiation
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Assess site suitability by reviewing staff qualifications, prior experience with clinical trials, and site infrastructure.
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Conduct pre-study visits (PSVs) to evaluate the site’s ability to meet study requirements.
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Verify the site’s patient population aligns with the study protocol.
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Assess site suitability by reviewing staff qualifications, prior experience with clinical trials, and site infrastructure.
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Conduct pre-study visits (PSVs) to evaluate the site’s ability to meet study requirements.
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Verify the site’s patient population aligns with the study protocol.
2. Regular Monitoring Visits
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Compare data in the Case Report Forms (CRFs) with source documents to ensure accuracy and completeness.
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Confirm that all adverse events are reported per protocol and regulatory requirements.
3. Risk-based monitoring
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Prioritize monitoring efforts based on identified risks, such as high patient enrollment sites or deviations from protocol.
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Utilize centralized data analytics to detect patterns or anomalies (e.g., missing data, outliers).
4. Issue identification and resolution
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Identify protocol deviations, regulatory non-compliance, or data discrepancies during monitoring visits.
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Recognize root causes of issues through detailed investigation.
5. Reporting and communication
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Prepare detailed monitoring visit reports, including observations, deviations, and follow-up actions.
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Ensure all findings are documented in compliance with GCP and sponsor requirements.
