Risk-based Monitoring: Overview and Functional Strategies for Digitalization | HCL Whitepaper

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The cost and complexity of clinical trials have increased drastically in recent years. Despite technological advancements, there has been a dip in clinical trial process efficiency. Traditional monitoring process not only accounts for a larger percentage of clinical trial cost, but it may also lead to data quality/integrity issues like frauds, fabrication, and other transcription-based errors.

The increased number of FDA’s Warning Letters on trial monitoring, majorly for non-compliance to GCP and/or Protocol, along with lack of promptness to rectify the insufficiencies identified through monitoring, has justified the need for guidelines on RBM.