Practical Tools and Techniques for Project Planning and Control in Clinical Research

Abstract

Achieving a successful outcome in investigative trials is the most important objective in clinical research. Increasing the probability of meeting this objective requires careful planning and the inclusion of appropriate controls throughout the life cycle of a project. It is essential to determine the feasibility of conducting a trial through carefully structured surveys with a consortium of clinicians who have expertise in the therapeutic area of interest, preferably on a global basis. To optimize the initiation phase, a concentrated effort at the ‘front end’ of projects is necessary to appropriately set priorities so that timelines are realistic and achievable within the clinical development plan and at the conclusion.

Fundamental to the planning process is strategic planning and a well developed, in-depth project plan designed to provide the foundation to launch and execute trials successfully in accordance with the study protocol, and equally importantly, the regulations and guidelines. The most effective strategies and project plans are simplistic in design, thereby enabling seamless continuity among all project activities and adherence to budgetary constraints.