A Team-Oriented Approach to the Analysis and Reporting Process

Abstract

Coordinating the writing component with the operational components of a clinical trial can be very challenging. Traditionally, the final integrated report has been completed by a writing department, whose members may not have had regular access to the operational groups who conducted the trial. Access to these operational groups can be particularly difficult when the report is written by a contract research organization (CRO). To minimize problems of coordination between CRO and client and to maximize the clarity and accuracy of the report. Pharmaceutical Research Associates, Inc. has developed a model that involves a “team” of operations personnel in a matrix-like environment who each participate in both the conduct of the trial and in the completion of the final study report. Each reporting team is a subset of the larger, full-service project team and consists of representatives from biostatistics, analysis programming, medical writing, regulatory services, and medical affairs. The team produces a final study report in five distinct stages, each of which is passed to the client for approval before the subsequent stage is produced. By involving diverse team members throughout a reporting project, a CRO can provide clients with a high-quality and efficiently produced report while maximizing enthusiasm and cooperation among team members.