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International Clinical Trials

Preventable Problems

The development and delivery of cutting-edge medical treatments, drugs, and devices depends on the successful completion of clinical trials. Such studies require high-quality data, affordability, patient safety, and time sensitivity. In today’s clinical trial climate, data are everywhere. The ways in which participant information is now collected – from wearable devices to eJournals – means that researchers are inundated with usable, insightful data. This is undoubtedly an advantage to the integrity of clinical trials, but requires innovative, sophisticated technology and IT systems to cope. However, the complexity of modern-day clinical trials extends beyond data. Increasingly, large trials become harder to manage and traditional methods of study management are no longer always sufficient. Therefore, modern approaches are needed to ensure that trial quality and patient safety are retained.

Risk-based monitoring (RBM), as a component of an overall risk management approach, provides a platform for life sciences companies to enhance the quality and integrity of their clinical trials data by prioritising resources based on the safety of subjects. RBM is an adaptive approach that directs monitoring focus and activities to the areas needing the greatest attention, which have the highest ability to impact patient safety and data quality.

RBM is becoming one of the most valued approaches in clinical trial management; by improving data quality and allowing enhanced study oversight, RBM enables clinical trial managers to utilise technology to facilitate data integration. The ultimate goal is to move traditional RBM towards a management approach, one which is now standard across the industry.

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Sudeep Pattnaik is President and CEO at ThoughtSphere. Prior to founding ThoughtSphere, he was the global leader of products for Quintiles, the largest CRO Fortune 500 life sciences company in the world, creating and leading the strategy team behind a $60 million integrated healthcare data hub. Sudeep also played a key role in defining the risk-based monitoring approach for optimising the clinical development process and helped develop a best-of-breed RBM platform for the industry. He holds an MSc in computer science from Uktal University, India, and an MBA from Leeds School of Business at the University of Colorado, US.
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Sudeep Pattnaik
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