Auditing is a valuable tool to gain insight into the performance of your vendors, confirm you have oversight and assure inspection readiness. Collaborations and delegation of tasks among several stakeholders is common in clinical trials. However, as a sponsor you have the obligation to keep oversight, and to take responsibility for regulatory compliance, ethical conduct and the quality and integrity of your clinical data.
Clinical audits are performed to evaluate compliance with the protocol, the procedures, International Standards and the applicable regulatory requirements. An audit can cover all or some of the involved parties, systems and facilities and is performed independent of, and separate from, routine monitoring or quality control functions.
CRU-GLOBAL brings experience in hosting and conducting auditing services, and implementing the lessons learnt from these audits into the client active research programs.
Auditing team (such as the monitoring team) is an independent department from the clinical sites and clinical team. Upon sponsor request CRU-GLOBAL could contract external auditors.