Identification and Qualification of Foreign Contract Research Organizations

Abstract

As pharmaceutical research becomes increasingly global in scope, and as the pace of the development process increases, foreign external resources will become more and more critical to these processes. Within the very recent past, several US-based Contract Research Organizations (CROs) have established European operations or have established “joint ventures” with European CROs. Similarly, European CROs have begun to develop US operations. Regardless of whether foreign research is conducted “under the IND” or not, protecting the quality of clinical data is simply good business sense. The first step toward this objective is a careful evaluation of the proposed CRO: abilities, resources, and experience. Experience in conducting IND studies (and finding investigators willing to meet IND regulatory and quality requirements) becomes a critical factor. Special attention needs to be given to such issues as signed v oral informed consent, IRB v Ethics Committee, and review of source documents. Like their US counterparts, foreign CROs frequently promise more than they can provide, and it is best to be aware of that before the contract is signed.