Emerging Roles of Project Management in Clinical Research Organizations
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
EMERGING ROLES OF PROJECT MANAGEMENT IN CLINICAL RESEARCH ORGANIZATIONS OLALEKAN E. ODELEYE,PHD Project Manager
MILANKOVACEVIC, MD, PHD Medical Officer
CARLR. TORCHIO Director of Project Management Project Management, Clinical Operations, Kendle International, Inc., Cincinnati, Ohio
Centralized management of outsourced clinical trials is a relatively new concept in many contract research organizations (CROs).As pharmaceutical developers increasingly partner in the drug development process with CROs to manage their sponsored clinical trials, the role of project managers in CROs has undergone rapid transformation from its inception in the early 1970s. The roles and responsibilities of project managers in CROs have evolved along a path that is closely aligned to sponsor demands-to accelerate research and development time and save costs. In parallel, CROs have incorporated project management into the operational process of executing sponsored research as an instrument to achieve desired productivity and provide eflcient and quality sewices to sponsors. This article examines the evolution of the structuresflunctions of project management and project managers, the development of project management and managers' roles and responsibilities, and the anticipated future direction as shaped by internal and external forces that will impact the divisional structure and functions of project managers in CROs. Key Words: Project management; Project managers; CROs; Outsourcing; Clinical operations
INTRODUCTION CONTRACTING OUT (OR outsourcing) pharmaceutical development activities has evolved rapidly in recent years. Clinical spending for outsourced work to contract re-
Presented at the DLA 36th Annual Meeting, June 1115, 2000, San Diego, California. Reprint address: Olalekan E. Odeleye, PhD, Kendle International, Inc., 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202. E-mail: Odeleye.olalekane@ kendle.com.
search organizations or clinical research organizations has increased from $1.2 billion in 1986 to a projected level of $5 billion in 2000 (1). It has now reached a point where pharmaceutical and biotechnology companies outsource part of or even an entire drug development program as a realistic option (2).This has occurred due to industry downsizing of its manpower, cost containment practices, drug development globalization, and the rise of competitive and competent CROs which specialize in conducting clinical studies on behalf of sponsors and assist-
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Olalekan E. Odeleye, Milan Kovacevic, and Carl R. Torchio
ing the development efforts of developers (3). This rapid growth of service providers to the pharmaceutical industry is changing not only the relationship between the company and its vendors but also the entire internal arrangements and administrative structures-particularly the project management unit of CROs. In CROs, the project management unit or
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