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ICH-GCP defines monitoring as “the act of overseeing the progress of a clinical trial”, that is, ensuring that the trial is conducted according to protocol, GCP, standard operating procedures (SOP) and regulatory requirements.
One of the key activities performed by a clinical research associate (clinical monitor) during a monitoring visit is the source data verification (SDV). The purpose of this procedure is to ensure the accuracy and integrity of the data and to verify that the patient’s rights are protected. The monitor checks data entered into the database (electronic data capture; EDC) or case report form (CRF) against the data in the source documents.
Clinical monitoring services can be provided by Synergy based on its standard operating procedures (SOP) as well as on the ground of client’s SOPs.
Synergy’s risk based monitoring (RBM) strategy not only further enhances human subject protection but also helps ensure the improved quality of clinical trial data for our Sponsors.
Clinical monitoring activities that comply with the requirements of regulatory authorities, including Roszdravnadzor (Russian Federation) and similar institutions in EAEU and CIS countries), the Food and Drug Administration (FDA, USA) and the European Medicines Agency (EMA, EU countries) result in excellent oversight and improved quality of data while enhancing protection of the patients’ rights and well-being.
Synergy’s monitoring activities are fully aligned with ICH GCP E6(R2) and FDA’s Guidance for Industry on A Risk-Based Approach to Monitoring.
The adoption of RBM for quality risk management means that Synergy’s strategy further enhances the highest level protection of the patients’ rights and well-being.
This risk-based approach to monitoring including centralized monitoring allows Synergy excellent oversight of all study data throughout the duration of the study to ensure the improved quality of clinical trial data.