Heart Failure RACT Now Available
Heart Failure (HF) is a complex clinical syndrome. Our CSO, Dr Johann Proeve, explains the challenges associated with the conduct of clinical studies in the various heart failure stages.
Dec
2019
Sep
2018
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
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
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
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.