ICH GCP Goes Risk-Based
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.
Oct
2015
Oct
2015
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 a survival kit for a modern pharmaceutical company. Due to [...]
Oct
2015
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 standards are still valid. The new GCP addendum introduces three [...]
Oct
2015
VW Scandal – Data Integrity Issue?
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 [...]
Sep
2015
GCP Change – New Risks for Biotech?
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 [...]
Sep
2015
ICH GCP Addendum Mind Map
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 [...]
Sep
2015
RBM From Idea to Implementation
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 [...]
Sep
2015
Meet Cyntegrity on 20th DGGF International Meeting in Ulm
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 [...]
Aug
2015
Risk-Based Quality Management as a Survival Kit
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 [...]
Aug
2015
New Publication at DIA Global Forum
Quality Risk Management as A Survival Kit: From Idea to Implementation Cyntegrity is happy to present a new article at DIA global Forum written by by Randy Ramin-Wright and Artem Andrianov. The article addresses such questions as: what in embracing of RBM one should start with, [...]