Volker Hack

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.

As more strategic partnerships emerge, demands on CROs have intensified-resulting in the need for next-level competencies for project managers.

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.