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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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Charles River and Distributed Bio Enter Exclusive Partnership to Create an Integrated Antibody Discovery and Development Platform
Charles River Laboratories International, Inc. (NYSE: CRL) today
announced that it has entered into an exclusive partnership with Distributed Bio, Inc., a leader in the computational design and optimization of antibody discovery platforms.
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White Papers |
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Overcoming research challenges with Adaptive Trials
PCI Pharma Services
There has been cause for concern within the pharmaceutical industry over
the last five years, regarding increasing research and development
costs, combined with a fall in the number of new drugs brought to
market. In an attempt to overcome this issue there has been a
significant rise in the use of adaptive clinical trial designs, whilst
saving time and money as well as facilitating more effective decision
making. One of the biggest challenges that pharmaceutical companies have
experienced has been delivering compliant clinical trials supplies
across diverse patient populations in the relatively short timeframes
that adaptive trial designs require, remaining focused on ensuring that
patient compliance and product quality is in no way compromised. This
demand has led to the launch of fast response services that support
Research and Development in responding to changing dosing regimens
mid-trial.
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Industry Events |
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Biotech Showcase™ 2019
7-9 January 2019, Hilton San Francisco Union Square
Biotech
Showcase™ is an investor and networking conference devoted to
providing private and small- and mid-cap biotechnology companies an opportunity
to present to and meet with investors and biopharmaceutical executives during
the course of one of the largest annual healthcare conferences that attracts
investors and biopharmaceutical executives from around the world.
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