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 SDV in a clinical monitoring process, shows the path of [...]
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 [...]
A good RBM Command Center is the heart of a clinical trial. It pumps the most important (risk-relevant) information among the team members. In order to develop a good RBM Command Center many iterations must be undertaken. Many errors have to be made. Moreover, it [...]
Recent research shows, the size of sponsors correlates with the size of service providers. Big Pharma relies on the large, full-service CROs if they are running a large clinical trial. As the outsourcing world has always moved in cycles, today, there is [...]
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.
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 [...]
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 [...]
