The FDA is emphasising the key role both sponsors and CROs play in ensuring high quality 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 organisations (CRO) sponsors can eliminate some potential problems.
“A sponsor has to indicate what specific responsibilities they’re transferring to the CRO in writing. Anything that’s not specifically described in writing is deemed to be retained by the sponsor”, Ann Meeker O’Connell, acting associate director at the FDA, told Outsourcing-Pharma.
Sponsors encounter problems when there is “a lack of clarity in the transfer of obligations”. Other problems can arise when a sponsor only provides limited real-time oversight in managing the CRO.
Meeker O’Connell goes on to list four areas sponsors must address to ensure a smooth transfer of responsibilities to a CRO. While this is important, sponsors must remember they “retain the ultimate responsibility for the quality and integrity of any data…that are submitted to the FDA”.