Free White Papers

Mar 2018

Blockchain in Clinical Trials – The Ultimate Data Notary

By |2018-03-14T14:00:11+00:00March 14, 2018|Free White Papers, 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.

Mar 2015

Implementing RBM: Avoid These 8 Common Pitfalls

By |2018-07-26T16:10:12+00:00March 31, 2015|Free White Papers|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.

Jan 2015

The RbM Consortium: 10 Burning Questions about Risk-Based Study Management

By |2016-11-16T18:35:47+00:00January 14, 2015|Free White Papers|1 Comment

Moe Alsumidaie, María Proupín-Pérez, PhD, Artem Andrianov, PhD, Beat Widler, PhD, Peter Schiemann, PhD, Johanna Schenk, MD, PhD Originally published on Applied Clinical Trials [link to the article]. Quality Risk Management (QRM), Quality by Design (QbD), Risk-based Monitoring (RbM), data driven monitoring or centralized monitoring [...]

Dec 2014

Duality of Risk-based Monitoring Definition: EMA vs FDA

By |2019-03-21T12:16:18+00:00December 9, 2014|Free White Papers|Comments Off on Duality of Risk-based Monitoring Definition: EMA vs FDA

In October 2014 at the Risk-based Monitoring conference in Copenhagen the Senior Director QA Operations of Janssen, Jan Van Parijs said: "Industry is historically heavily regulated, so as an industry we are kind of used to the fact that the authorities provide a set [...]

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