Finding and Evaluating CROs

Abstract

The use of clinical research organizations (CROs) has become increasingly common in recent years. Studies conducted by CROs are always expensive and, in almost all instances, important to the contracting company. For these reasons, it is vital that the best CRO be selected for the study at hand. The selection process must be taken very seriously and it should be remembered that the best CRO for one study may not be the best one for another study that differs in size, complexity, and/or therapeutic area. After identifying and screening a number of CROs, the final selection should include input from a number of people. These will come from clinical research, data processing, regulatory affairs, etc depending on the nature of the study. The IND regulations require that contracts be very specific concerning what responsibilities are to be transferred to a CRO. Time frames for completion of major tasks and penalties for noncompliance should be included in contracts. It is suggested that both the CRO and selected clinical investigators be visited periodically during a contracted study to help assure that the study is conducted on schedule and in compliance with applicable regulations.