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.
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 [...]
The RBM software EarlyBird® obtains 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. An example of such a [...]
In our previous "predictive analytics in RBM" article, we started a discussion about algorithms of machine learning (ML), predictive analytics, and artificial intelligence. We also covered that a risk software needs to calculate forecasts of Key Risk Indicators (KRIs) proactively and alerts when they [...]
Predictive analytics is a very useful tool in the risk-based monitoring and overall risk-based study management. It increases the proportion of correct decisions, as the decisions start being more data-driven. It also helps to understand for a central CRA or study manager the trending [...]
Video from our recent CyntegrityEDU Webinar - ICH E.6(GCP) Addendum Quality Tolerance Limits Part 1. ICH E6 background (Structural & Non-structural) Quality Tolerance Limits (QTLs) Brief history of QTLs How to use the QTLs Potential benefits Part 2. Technology consideration of QTLs Considerations of enabling [...]
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) . The next step is to unfreeze the knowledge of [...]
Picture source: http://independentaudit.com/tweeting-audit-findings-colour/ How to avoid audit findings in Risk-based Monitoring (RBM) and risk management environment? What are the most common findings in RBM? What are auditors looking for in risk management plans, SOPs and RBM guidance? If we can imagine a pharma hell, this [...]