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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.
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.
What our CRAs do for you
On-site monitoring
On site-monitoring is an in-person evaluation carried out by the ICTA monitor at an investigational site where the clinical investigation is being conducted.
REMOTE MONITORING
Remote monitoring is an off-site evaluation performed by the ICTA monitor away from the site where the clinical investigation is being conducted.
CENTRALISED MONITORING
Centralised monitoring is a site evaluation and source data verification carried out by the ICTA monitor at a central location other than the site where the clinical investigation is being conducted. This requires the use of secure digital tools to support communication between stakeholders and the sharing of sensitive documents using an electronic safe.
