Johann.Proeve

About Johann Proeve, Chief Scientific Officer

Dr Johann Proeve, our Chief Scientific Officer, has over thirty five years of experience working across the Pharma CRO industry, being the former Head of Global Data Management at Bayer AG.
Sep 2018

Optimizing Adverse Event Capturing and Reporting – 7 Questions to Ask

By |2018-09-20T06:40:12+00:00September 18, 2018|Blog|Comments Off on Optimizing Adverse Event Capturing and Reporting – 7 Questions to Ask

Adverse Event (AE) reporting, identified by the FDA as one of the most important challenges in clinical research, is known to be prone to under and over-reporting. When starting a project and considering the various ways available to capture the adverse event data, it’s important to ask yourself some analytical questions that help you improve AE and SAE capturing and reporting.

Mar 2018

Adaptive Monitoring: Anticipating The Human Factor

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

Mar 2018

Adaptive Monitoring: Beyond Data Trends and Timely Performance

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

Feb 2018

Adaptive Monitoring: The First Implementation Steps in Real-Life

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