Outsourcing in Clinical Trials

Outsourcing of clinical trials presents the US Food and Drug Administration (FDA) and companies with new issues around quality and responsibilities. By properly transferring responsibilities to contract research organizations (CRO) sponsors can eliminate some potential problems. As sponsor has to indicate what specific responsibilities they are transferring to the CRO in writing. Anything that’s not specifically described in writing is deemed to be retained by the sponsor.

Globalization, outsourcing and increasing complexity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies.