While cardiovascular outcome trials are critical to demonstrating clinical value, they can also be complex and costly. Among the most challenging aspects are the people involved, from patients to investigators and commit...
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Postmarket Surveillance and M&A
Vicki Anastasi discusses how a merger or acquisition can impact your medical device’s post-market surveillance strategy.
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What Errors Do We Miss in Clinical Trials
Clara Heering, Vice President of Clinical Risk Management, examines the deficits in current risk mitigation approaches and presents a new paradigm for risk management that is aligned with the new ICH GCP guidelines.
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5 Things to Know About ICH GCP (R2) 2016
The rising risk of errors, particularly those with complex sources that may be difficult to ascertain in large organisations.
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Relationships Matter
In this article Dr. Martin Lachs explains about ongoing clinical trials in the oncology area.
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Free-living Physical Activity in COPD Patients
Deriving methodology standards for clinical trials through a review of research studies.
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Go and No Go Decisions – Optimizing Design Strategies
Hear perspectives from ICON’s Uma Arumugam, MD in Applied Clinical Trials on utilizing historical data and employing clinically meaningful outcomes in a clinical trial design.