Risk-basedMonitoring
Clinical monitoring ensures the integrity, accuracy, patient safety and compliance of your clinical trial. We provide thorough and proactive monitoring services, protecting your data quality and ensuring strict adherence to Good Clinical Practice (GCP), regulatory and protocol requirements.
Our service includes
Risk-Based Monitoring (RBM)
Implementation of tailored, risk-based strategies that optimize monitoring activities, ensuring maximum efficiency.
Site Initiation Visit (SIV), Site Close-out visits (COV) and trainings
Preparation of visits and trainings for study teams, systematic completion of all monitoring activities, ensuring accurate data verification, resolution of queries, and thorough documentation review.
On-site and Remote Monitoring Visits
In accordance with the monitoring plan, we review trial sites to verify protocol adherence, data accuracy, and regulatory compliance, while ensuring that any identified issues are addressed in a timely and documented manner.
Data Verification and Quality Assurance
Rigorous verification of clinical data to confirm consistency, reliability, and accuracy, significantly enhancing the quality of the final datasets.
Investigator and Site Support
Dedicated support to site staff, proactively resolving operational issues and reinforcing protocol adherence throughout the trial lifecycle.
With GALSER, your trials benefit from precise, structured monitoring, safeguarding your clinical data quality and regulatory compliance from start to finish.
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