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Sep 2021

Risks of IMP Management Under Standard vs. Pandemic Conditions

By |2021-12-22T16:59:18+00:00September 30, 2021|Blog, Case Studies|Comments Off on Risks of IMP Management Under Standard vs. Pandemic Conditions

The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.

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Nov 2020

Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

By |2021-12-22T17:37:35+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Avoiding Regulatory Non-Acceptance

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

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Nov 2020

Best Case Studies for RBQM | Controlling the Number of Open Queries

By |2021-12-22T17:41:30+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Controlling the Number of Open Queries

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

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Nov 2020

Best Case Studies for RBQM | Accurately Predicting Important Events

By |2021-10-25T13:55:23+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Accurately Predicting Important Events

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

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Nov 2020

Best Case Studies for RBQM | Detecting and Mitigating a Conflict of Interest

By |2021-12-22T17:42:58+00:00November 3, 2020|Blog, Case Studies|Comments Off on Best Case Studies for RBQM | Detecting and Mitigating a Conflict of Interest

We've documented real-life case studies for you, illustrating how the MyRBQM® Portal helped address common risks using the principles of risk-based quality management.

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Mar 2020

Best Case Studies for RBQM | Merz Pharma’s RBQM Journey

By |2020-11-03T14:50:45+00:00March 5, 2020|Case Studies, News|Comments Off on Best Case Studies for RBQM | Merz Pharma’s RBQM Journey

This week Applied Clinical Trials published an interesting case study of the risk-based quality management learning curve. The provision of a set of training modules helped Merz Pharma to initiate a smooth RBQM rollout.

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Mar 2018

Adaptive Monitoring: Anticipating The Human Factor

By |2018-03-21T19:31:12+00:00March 21, 2018|Blog, Case Studies|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.

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Mar 2018

Adaptive Monitoring: Beyond Data Trends and Timely Performance

By |2018-06-03T14:21:15+00:00March 7, 2018|Blog, Case Studies|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.

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Feb 2018

Adaptive Monitoring: The First Implementation Steps in Real-Life

By |2018-03-07T12:56:48+00:00February 13, 2018|Blog, Case Studies|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.

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