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news roundup
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Immuno-Oncology Insights:
Top 5 Challenges in Today’s Immuno-Oncology Trials
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Medidata has acquired Intelemage, a medical image sharing and workflow management provider and it will be integrated into the Medidata Clinical Cloud.®
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Overcoming regulatory and statistical hurdles of biosimilars drug development
Designing smarter trials
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A main component of the collaboration is a co-hosted ground-breaking event in September 2016 called the “Inspiring Hope” Ideathon.
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Mitigating risk using Risk-based Monitoring
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Learn how risk-based monitoring (RBM) is transforming clinical development by mitigating risk while optimizing execution. Understand how to achieve enhanced patient safety with improved quality to execute your RBM studies with confidence.
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Acquiring, Tracking and Maintaining Biological Study Samples for Complex Study Designs
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Advancing Drug Development with Digital Health
4 Key Ways to integrate Patient - Generated Data into Trials
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Regulatory
These principles can be applied to any audit or government inspection, be it GCP, CQA (Clinical Quality Assurance), or other.
MHRA's definition is identifying new uses for existing drug in another indication, or creating novel combinations and says it is “an emerging and dynamic field of drug development.”
Dr. Christa Wirthumer-Hoche has been head of the Austrian Medicines and Medical Devices Agency since October 2013, and has served as vice-chair of EMA's Management Board since March 2015.
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Articles
Quality issues lead to increased data variability, undermine the validity of the results of a trial and require increasing the number of subjects in a trial.
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Blog Posts
Begin by “thinking beyond the meeting,” or discerning how attendees can be reached with meaningful content and experiences before, during and after the event.
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