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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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News and Press Releases |
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PPMA Group Industry Awards 2018 Call for Entries – Deadline 31st July
The PPMA Group Industry Awards,
which recognise manufacturing excellence, technical innovation,
entrepreneurship as well as outstanding achievement and contribution to
the industry, will this year take place at a new venue – the Hilton
Birmingham Metropole Hotel at the NEC - on the 25th September 2018.
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Why You Should Be Using Ultrasonic Cleaning
Natoli Engineering Company, Inc.
Clean punches and dies are essential to maintaining the integrity and efficiency of your tooling investment, as well as the quality of your product. Ultrasonic cleaning has long been considered the most effective, nondestructive way to clean tools – from medical instruments to tablet tooling. The Tableting Specification Manual (TSM) states, “An ultrasonic bath is ideal for cleaning tooling.” This high-tech cleaning process also saves time, reduces cost and is better for the environment.
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Industry Events |
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SMi’s 9th Annual Biosimilars & Biobetters Conference
25-27 September 2018, Copthorne Tara Hotel, London, UK
Following the success of our previous events in both London and the US,
Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker
line-up and bring together a global audience of biosimilar experts to
discuss the latest developments and future of the rapidly evolving and
expanding biosimilars market.
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