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International Clinical Trials

What Is The Risk?

Access to high-quality, real time data is the driver behind risk-based monitoring (RBM) – a methodology used to enhance subject safety and data quality, and to deliver significant efficiency benefits. An RBM approach replaces the in-person, 100% source data verification (SDV) process based on the identification of risks and issues. Its use in clinical trials is increasing as sponsors begin to realise the potential to improve the quality of data while, at the same time, reducing total trial costs by an estimated15-20% (1). This approach is also in line with the push from regulatory authorities in the US and EU for targeted monitoring, as it is more effective than spreading resources equally across all sites.

However, managing and analysing all clinical data during the study – to identify potential current issues and future risks – is a complex speciality, which becomes particularly challenging in global, multi-site trials. Large pharmaceutical companies and CROs may have entire departments devoted to this, but that kind of scope and expertise is expensive and, for many small- and midsized biopharmaceutical and device organisations developing a product on a budget, it simply may not be an option.

Aligning these smaller teams with affordable and robust technologies, which enable the adoption of a risk-based approach to study monitoring, creates cost efficiencies that can significantly benefit them without compromising data value or patient safety.

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Greg Ambra is Vice President of Clinical Operations at DZS Clinical Services. With nearly 20 years of experience in the clinical research industry, he has held strategic leadership positions in various sponsor and CRO companies. Greg has led DZS Clinical Services since 2012, and earned his Master’s degree in Medical Sciences from Boston University, US.

As Senior Director of Biostatistics, Jean Battikha has worked in the pharma industry as a statistician for nearly 40 years. He has been involved in the design, analysis and reporting of many clinical trials across several therapeutic areas, as well as with many NDA submissions in both the US and EU.
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Greg Ambra
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Jean Battikha
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