Specialized Oversight in Ophthalmic Clinical Trials
We oversee trial conduct through a structured monitoring plan tailored to each clinical project, ensuring protocol compliance, data quality, and adherence to Good Clinical Practice (GCP) and ICH E6 (R3) guidelines.
Comprehensive Monitoring
We combine on-site and remote oversight to provide a complete view of the study. This approach enables early identification of operational, clinical, and data-related risks.
Source Data Verification (SDV)
We cross-check recorded data with source documentation to ensure accuracy.
We prioritize the review of critical variables that impact patient safety and study outcomes.
Protocol Adherence
We identify, record and analyze any deviation from the protocol or procedures.
We apply corrective actions and follow up to prevent recurrences.
Deviation Identification & Management
All protocol or study SOP deviations are carefully recorded and analyzed. Immediate corrective actions are implemented, followed by continuous tracking to prevent recurrence.
GCP-Compliant Audits
We conduct periodic assessments to verify compliance with GCP and applicable regulations.
We ensure data integrity and participant protection.
Quality Reporting
We generate regular reports including findings, key metrics, and implemented actions. We facilitate informed decision making and continuous improvement of the study.
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