Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.
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 [...]
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 [...]
What are the most common risks in clinical trials? What challenges faces TransCelerate RACT? Read the answers in the latest article published on ACT. by Moe Alsumidaie, Beat Widler, PhD, Peter Schiemann, PhD, Artem Andrianov, PhD Do you want to know about @RACT more and start using [...]
Going Public Biotechnology Magazine p.76-77 The new upcoming GCP E6(R2) addendum reforms clinical monitoring and clinical trial management. Risk factors are an important component. What this means for a biotech company: clinical trial risks are easy to foresee, site level risks and operational risks are [...]
From Idea to Implementation (by Randy Ramin-Wright and Artem Andrianov) DIA Global Forum: Efficient risk management becomes more than advice today, it becomes part of a survival kit for a modern pharmaceutical company. Due to increasing trial complexity, regulatory scrutiny, competition for patients and high [...]