The Changing Role of Cros: The Evolution of Strategic Out-Sourcing

Abstract

The CRO industry is evolving rapidly from a history of isolated individual bidding, where CROs were basically order-takers, to carefully defined strategic relationships, where Sponsors and CROs work together to set new standards of rapid and economic drug development through to enhanced product launch and market penetration. This paper will examine several key parameters of the Sponsor-CRO relationship, including resource planning, shared investments, project teams and infrastructure, and setting and achieving expectations. Lessons from the past will be examined as well as ideals for current and future working relationships. Strategic out-sourcing is defined as the establishment of a plan for functional, therapeutic, and managerial core competencies, whereby the Sponsor and CRO each work together to allocate competencies across the joint relationship with clearly established, measurable goals for operating together to achieve targeted outcomes. Although not all Sponsor-CRO relationships will seek to cooperate at the strategic level, each of the areas examined in this paper may still have applicability at the project-by-project level.