Blockchain in Clinical Trials – The Ultimate Data Notary
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.
What SDV is really for? How it develops and to what form it evolves? What is the future role of a CRA? This article depicts a role of [...]
Guide for Risk-based Monitoring Technologies
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 [...]
How does the New GCP Addendum Influence Clinical Monitoring?
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 [...]