Blockchain technology is the biggest achievement in cryptography of the past decade. Source Data Verification (SDV), which consumes about 20–30% of the clinical trial budget nowadays, will become redundant when blockchain technology disrupts the pharma industry.
“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 [...]
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 [...]
By Ramin-Wright, Randy, Director of Quality Risk Management, Clinerion Ltd., Basel Switzerland and Andrianov, Artem, Ph.D., Managing Director, Cyntegrity Germany GmbH, Frankfurt Germany Efficient risk management becomes more than advice today, it becomes part of a survival kit for a modern pharmaceutical company. Due to [...]
The International Conference on Harmonisation (ICH) did not change the Good Clinical Practice (GCP) since the mid of the 1990th. However, the scale, complexity and cost of clinical trials increased although the ethical and scientific standards are still valid. The new GCP addendum introduces three [...]
A good RBM Command Center is the heart of a clinical trial. It pumps the most important (risk-relevant) information among the team members. In order to develop a good RBM Command Center many iterations must be undertaken. Many errors have to be made. Moreover, it does [...]
Recent research shows, the size of sponsors correlates with the size of service providers. Big Pharma relies on the large, full-service CROs if they are running a large clinical trial. As the outsourcing world has always moved in cycles, today, there is [...]
If not applied appropriately, Risk-based Monitoring could generate certain risks that influence data quality and patient safety inversely. Adopting an RBM approach involves more than applying some 'formula'. This white paper lists the 8 most common pitfalls of RBM implementation and expert suggestions on how to avoid them.