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Globalization of clinical trials, and the complexity surrounding the execution of these trials, has stimulated pharmaceutical companies to review their decision making processes to include input from affiliates and outsourced vendors that will be involved in the conduct and execution of the trial. In determining how the study will be directed and which affiliates and contract research organizations (CROs) will be used, registration requirements must be balanced with commercialization needs. Communication is much more complex and affects all aspects of execution from investigator selection to project management. Centralized (eg, corporate) or decentralized (eg, regional) decision making models have an impact on timelines and achievement of milestones. This report identifies the challenges in conducting global clinical trials and addresses issues such as affiliate and CRO selection, project management, investigator selection, site management, on-site monitoring, and regulatory issues. Audience input was solicited and compiled through interactive electronic device technology. An analysis of the results is provided in this paper.

Globalization of clinical trials, and the complexity surrounding the execution of these trials, has stimulated pharmaceutical companies to review their decision making processes to include input from affiliates and outsourced vendors that will be involved in the conduct and execution of the trial. In determining how the study will be directed and which affiliates and contract research organizations (CROs) will be used, registration requirements must be balanced with commercialization needs. Communication is much more complex and affects all aspects of execution from investigator selection to project management. Centralized (eg, corporate) or decentralized (eg, regional) decision making models have an impact on timelines and achievement of milestones. This report identifies the challenges in conducting global clinical trials and addresses issues such as affiliate and CRO selection, project management, investigator selection, site management, on-site monitoring, and regulatory issues. Audience input was solicited and compiled through interactive electronic device technology. An analysis of the results is provided in this paper.

AbstractThe 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-sourcingis 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.