Optimizing Clinical Monitoring Practices Risk Based Monitoring
Traditionally, the sponsors believe that regulatory agencies expect frequent onsite monitoring visits assuming the fact that 100% Source Data Verification (SDV) is required for all trials irrespective of study design or complexity. Even with intense monitoring, neither the integrity of data nor investigators performance has improved. A large amount of capital is spent in clinical research which usually takes eight to ten years to arrive to a result. Clinical monitoring accounts for about 35-40% of clinical development project cost. It is one of the largest drivers of cost in a clinical trial and plays a critical role in ensuring the conduct and fortune of a clinical trial to bring the investigational drug to market. But over the time Sponsors and CROs have built a paradigm for the necessity for intense monitoring by performing 100% source data verification (SDV) to assure the integrity of the study processes and data. The evolving clinical trial industry is looking forward to streamline the processes of clinical monitoring to improve patient safety and data integrity.
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