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International Clinical Trials
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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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Industry Events |
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PDA Universe of Pre-Filled Syringes and Injection Devices
8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL
At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments,
regulatory considerations, challenges, and industry trends and best practices.
This is a must-attend event for all industry professionals involved in the
development, manufacturing, testing, or marketing of pre-filled syringes and
injection devices.
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