There is a rapidly growing amount of information to process in clinical research. You could argue whether it adds value viewing and verifying the reliability of each single data point. Dirty data and frauds have always existed but can eventually be marginalised by responsive people and processes.
Believe it or not, it was Guinness’ biochemist Gosset who developed the first Six Sigma statistical test in the early 1900s. The Guinness brewery was far ahead of its time by hiring statisticians, chemists and other scientists to improve the quality of its beer.
“There are always a million reasons not to do something” A great inspiring quote from Jan on an episode of The Office when Pam was making excuses not to go to Art school. A very recognisable habit, isn’t it? Talking ourselves out of doing [...]
MyRBQM® Portal's predecessor EarlyBird® RBM software deploys a powerful and flexible system for ad-hoc reporting of risk-relevant data. It can be used to explore clinical data in more detail, prepare centralized monitoring reports, and build up a risk overview across studies. The video [...]
In our previous "AI-driven predictive analytics in RBM" article, we started a discussion about algorithms of machine learning (ML), predictive analytics, and artificial intelligence (AI). We also covered that a risk software needs to calculate forecasts of Key Risk Indicators (KRIs) proactively and alerts [...]
AI-driven Predictive Analytics is a very useful tool in risk-based monitoring and overall risk-based study management. It increases the proportion of correct decisions once the decisions start to become more data-driven. It also helps to understand for a central CRA or study manager the [...]
Four stages of RBM Evolution in a Pharma Company Intelligent software systems are facilitating the data accumulation in clinical trials already. The 75% of clinical trials are conducted with the Electronic Data Capture (EDC) [1]. The next step is to unfreeze the knowledge of [...]
How to avoid audit findings in a Risk-based Quality Management (RBQM) and risk management environment? What are auditors looking for?
The new Risk-based Monitoring concept reforms the clinical monitoring and clinical trial management. Risk factors become an important component there. What does it mean for a pharmaceutical company? Clinical trial risks are easy to foresee, site level risks and operational risks are hard to [...]
The article covers the topics of clinical trial budgeting when applying the risk-based monitoring (RBM) model. The problem is that the new monitoring model requires a new model of clinical trial budgeting too, while today, the common practice is to apply traditional fixed-price budgeting. [...]
