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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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PlasmidFactory Announces Appointment of Berthold Hackl and Dr. Eduard Ayuso to Board of Directors
Bielefeld, Germany - Leading contract manufacturer and service provider for plasmid and minicircle DNA - PlasmidFactory - announces today the appointment of two board members, Berthold Hackl and Dr. Eduard Ayuso as chairman and member of the board, respectively.
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White Papers |
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Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.
Medpace
Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
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