The Planning Paradigm: The Marriage Between Clinical Operations and Project Management
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Drug Infomarion J o u m l , Vol. 35, pp. 1039-1042, 2001
Printed in the USA. All rights reserved.
THE PLANNING PARADIGM: THE MARRIAGE BETWEEN CLINICAL OPERATIONS AND PROJECT MANAGEMENT DENISER. WILLS,MBA Project Director, Clinical Operations, Covance CAPS, Inc., Princeton, New Jersey
The success of clinical trials involves a strong bond between clinical operations and project management throughout the life cycle of a project and clinical development plan. A concentrated effort on the front end of projects is necessary to expertly set priorities appropriately so that timelines are realistic and achievable, Some of the major components critical to the mix are the organization, planning, and execution of start-up activities in clinical operations, the development of sound strategic planning by project management, a cohesive project team, solid and consistent leadership and constant interaction between all departments and disciplines, and training. The development of a solid project plan as a foundation to include tools to adequately assess anticipated potential risks with contingency plans will provide the basis for successful implementation and execution. It is also a key component to identifi study staff with relevant skills and experience appropriate to work on specific projects to achieve an overall fit. Development of a training program to prepare the internal and field project members must be designed in order to effectively execute strategies. Also critical to the mix, priority must be given to the development of effective modes of communication to ensure seamless interactions among the members of the project team internally and externally, and to track key study parameters in order to measure the true progress of a program at any given moment. In this article, tools to prepare strategic project plans, effective management of all study sta& manipulation of timelines to achieve on time completion of studies, and strategies to minimize queries to accelerate study and database closure at the conclusion of studies will be discussed. Key Words: Clinical trials; Project management; Clinical operations
INTRODUCTION
Project management focuses primarily on tracking key study parameters throughout the To SUCCESSFULLY and manage life cycle ofa program to assist clinical operclinical projects, it is important to develop ations to successfully execute studies and to and maintain a solid cohesive bond between drive timelines. In order to so do, there must clinical operations and project management. be a clear understanding of the goals and objectives of the clinical development plan and the Dertinent Darameters most likelv to Reprint address: Denise R. wills, MBA, Project Direc- directly a iositive mus; be tor. Clinical Operations, Covance CAPS, Inc., 210 Caridentified. It is absolutely essential to visualnegie Center, Princeton, NJ 08042. ize and UKkrstand the importance ofthe “big Presented at the DIA Annual Meeting, June 1 1-15. 2000, San Diego, California. picture” and the significant details that devise
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