Volker Hack


Risk-Based Quality Management: The Importance of Risk Communication

June 19, 2019

Amid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.

The Changing Role of the CRO and its Effect on Project Management

October 21, 2016

Market trends are driving the need for biopharma to decrease fixed costs, leading to increased outsourcing to CROs. To meet greater demand, the role and profile of Project Managers needs to continuously adapt to an ever changing clinical trial environment.