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 [...]
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 [...]
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 [...]
The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP. Let [...]
Join the top RBM community in our newly reworked Webinar with latest RBM insights: How to improve risk awareness and mitigation from clinical study planning How RbM enhances time and financial control What the next upcoming GCP change will bring Read more and [...]
On 24th-25th of September 2015 Artem Andrianov, CEO of Cyntegrity, speaks on 20th DGGF International Meeting in Ulm, Germany. DGGF (German Society for Good Research Practice) is a platform to discuss quality management in pharma world. The CEO of Cyntegrity Artem Andrianov speaks about experience of application of [...]
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 [...]
