Mar2016

SDV Evolution

March 7, 2016|0 Comments

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 [...]

Oct2015

Guide for Risk-based Monitoring Technologies

October 8, 2015|1 Comment

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 [...]

Oct2015

How does the New GCP Addendum Influence Clinical Monitoring?

October 6, 2015|0 Comments

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 [...]

May2015

RBM Command Center. Make or Buy?

May 22, 2015|0 Comments

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 [...]