Contract Research Organizations: Enhancing Quality through Systematic Interviews with Sponsor Companies

Abstract

Contract research organizations (CROs) handle an increasing amount of clinical research for pharmaceutical companies. By contracting work to an outside organization, sponsors relinquish some control of the conduct of their studies. It is incumbent on both the CRO and the sponsor to communicate effectively in order to ensure the quality of the research. Communication begins during contract negotiations, and carries through in the day-to-day collaboration as the study proceeds.

As one assessment of the quality of the collaboration, Quintiles Transnational Corp., a CRO, conducts telephone surveys of its client companies. The survey questions are primarily open-ended, and interviews last 10–15 minutes. Results of the surveys are summarized in a matrix format: general issues such as training and resources are reported to management; project-specific findings are reported to the project manager. Positive and negative comments are reported, and the importance of continuous improvement is emphasized. The sampling technique, preparation, format, and examples of findings will be described.

Although systematic client interviews are not traditional components of quality assurance (QA), their role in quality management can be helpful to CROs that want a comprehensive approach to client satisfaction. The advantages and potential drawbacks of the surveys in terms of client expectation and staff motivation will be discussed.