Free White Papers for Clinical Experts

Mar 2018

Blockchain in Clinical Trials – The Ultimate Data Notary

By |2018-03-14T14:00:11+00:00March 14, 2018|Free White Papers for Clinical Experts, News|0 Comments

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.

Nov 2017

Implementing RBM – Moving out of your comfort zone

By |2017-12-06T06:52:04+00:00November 23, 2017|Blog, Free White Papers for Clinical Experts, Library, Neat Features|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 |2020-02-25T08:59:46+00:00August 8, 2017|Blog, Free White Papers for Clinical Experts, Library, Neat Features, RBM Product Updates|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 |2018-10-08T07:31:04+00:00August 2, 2017|Blog, Free White Papers for Clinical Experts, Library, Neat Features|1 Comment

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 [...]

Oct 2015

Guide for Risk-based Monitoring Technologies

By |2017-04-28T09:18:25+00:00October 8, 2015|Free White Papers for Clinical Experts|1 Comment

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 [...]

Oct 2015

How does the New GCP Addendum Influence Clinical Monitoring?

By |2016-06-12T12:30:45+00:00October 6, 2015|Free White Papers for Clinical Experts|0 Comments

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 [...]

Mar 2015

Implementing RBM: Avoid These 8 Common Pitfalls

By |2018-07-26T16:10:12+00:00March 31, 2015|Free White Papers for Clinical Experts|2 Comments

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.

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