Risked-based Monitoring Case Studies

Risked-based Monitoring Case Studies 2017-10-03T04:49:21+01:00
Mar2018

Adaptive Monitoring: Anticipating The Human Factor

March 21, 2018|Comments Off on Adaptive Monitoring: Anticipating The Human Factor

An effective way to control risks during a clinical trial is to anticipate events induced by human factor before the study even begins. Dr Johann Proeve's third chapter on Adaptive Monitoring talks about how human factor is complementary to numeric data.

Mar2018

Adaptive Monitoring: Beyond Data Trends and Timely Performance

March 7, 2018|Comments Off on Adaptive Monitoring: Beyond Data Trends and Timely Performance

Adaptive Monitoring is not a “status quo”, it is a dynamic response to clinical research that drives monitoring scope and activities to the evolving areas of greatest need which have the most potential to positively impact. Each clinical study requires its own tailored monitoring approach ensuring risks are minimized.

Feb2018

Adaptive Monitoring: The First Implementation Steps in Real-Life

February 13, 2018|1 Comment

It is widely broadcasted that pharma companies will have to accelerate adoption of adaptive clinical trial designs to reduce study timelines and costs while increasing success rates. Risk-based Monitoring “Real RBM” integrates the Adaptive Monitoring (AM) process, which addresses all aspects of Quality Risk Management.

Dec2015

Clinical Trials: Viva Bias

December 2, 2015|1 Comment

by Alexandra Grossman Alexander K. is a thoughtful man, mid-50s, a writer by profession. He earns money with German and English lessons, and it is almost always tight. "A few years ago, I was sitting [...]

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