On 17 - 19 November 2015 Artem Andrianov, CEO of Cyntegrity, shares experience and case studies at Partnership in Clinical Trials in Hamburg during a PCT RBM workshop. The topic of the workshop will be dedicated to most burning RBM questions today like: - What KRIs and KPIs [...]
by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Originally published by Applied Clinical Trials Online Available: http://www.appliedclinicaltrialsonline.com/ich-gcp-goes-risk-based.
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 [...]
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 [...]
Photo by: Dave Granlund Data integrity is the fundamental property of any information. In its original meaning, data integrity refers to consistency and accuracy both within itself and in the context of real life. Today, we make many decisions based on captured data, and we [...]