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Dec 2017

Lean Six Sigma, a different term for the same concept

By | 2017-12-11T14:33:08+00:00 December 5, 2017|Blog, Library|0 Comments

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.

Nov 2017

Implementing RBM – Moving out of your comfort zone

By | 2017-12-06T06:52:04+00:00 November 23, 2017|Blog, Library, Weekly RBM Feature, White Paper|0 Comments

  “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 [...]

Aug 2017

Predictive Analytics in RBM (cont.)

By | 2017-09-18T19:55:38+00:00 August 8, 2017|Blog, Library, RBM Product Updates, Weekly RBM Feature, White Paper|0 Comments

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 [...]

Aug 2017

Predictive Analytics in RBM

By | 2017-10-04T17:01:30+00:00 August 2, 2017|Blog, Library, Weekly RBM Feature, White Paper|0 Comments

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 [...]

May 2016

Data from Global RACT Analysis Reveals Subjectivity

By | 2016-11-16T18:35:33+00:00 May 11, 2016|Library, News|0 Comments

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 [...]

Sep 2015

GCP Change – New Risks for Biotech?

By | 2016-11-16T18:35:43+00:00 September 21, 2015|Library, News|0 Comments

 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 [...]

Aug 2015

Quality Risk Management as a Survival Kit

By | 2016-11-16T18:35:44+00:00 August 26, 2015|Library|0 Comments

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 [...]

May 2015

ICH Goes Risk-Based

By | 2016-11-16T18:35:45+00:00 May 26, 2015|Library|0 Comments

ICH GCP Goes Risk-Based GCP Addendum Review and Embracement Plan by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Web-View AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes [...]